A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors (CAMELLIA-TIMI)

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in overweight and obese subjects with cardiovascular (CV) disease and/or multiple CV risk factors.

Study Overview

• Status: Completed
• Conditions: Obesity; Cardiovascular Disease; Overweight; Type 2 Diabetes; High Cardiovascular Risk
• Intervention / Treatment: Drug: Placebo; Drug: Lorcaserin hydrochloride

Detailed Description

Approximately 12,000 subjects will be randomized to two treatment groups in a ratio of 1:1, stratified by the presence of established CV disease (approximately 80%) or CV risk factors without established CV disease (approximately 20%). Subjects will receive lorcaserin HCl 10 mg BID or placebo BID. The study will consist of 2 phases: Prerandomization and Randomization. The Prerandomization Phase will last up to 30 days and consist of one visit during which subjects will be screened for eligibility. The Randomization Phase will consist of two periods: Treatment and Follow-up. The Treatment Period will last for approximately 5 years with approximately 18 visits and Follow-up period is 30 (+ or - 10 days) from the end of treatment visit.

• Study Type: Interventional
• Enrollment (Actual): 14673
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • South Australian Medical Research Inst, Centre for Clinical Research
  • New South Wales
    • Coffs Harbour, New South Wales, Australia, 2450
      • Coffs Harbour Health Campus
    • Gosford, New South Wales, Australia, 2250
      • Gosford Hospital, Cardiology Clinical Trials
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
    • Wollongong, New South Wales, Australia, 2500
      • Wollongong Hospital
    • Wollongong, New South Wales, Australia, 2500
      • Illawarra Shoalhaven Local Health District, Clinical Trial and Research Unit
  • Queensland
    • Brisbane, Queensland, Australia, 4064
      • Core Research Group
    • Brisbane, Queensland, Australia, 4102
      • Princess Alexandra Hospital, Cardiology Research Department
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital, Endocrinology Department
    • Milton, Queensland, Australia, 4064
      • HeartCare Partners Clinical Research Unit
    • Sherwood, Queensland, Australia, 4075
      • AusTrials Pty Ltd
    • Southport, Queensland, Australia, 4215
      • Gold Coast Hospital, Cardiovascular Research Centre
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • New Royal Adelaide Hospital, Cardiology Department
    • Ashford, South Australia, Australia, 5035
      • Adelaide Medical Research
    • Elizabeth Vale, South Australia, Australia, 5112
      • Lyell McEwin Hospital, Department of Cardiology
    • Fullarton, South Australia, Australia, SA 5063
      • Heart and Vascular Institute
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
  • Victoria
    • Ballarat, Victoria, Australia, 3353
      • Ballarat Health Services
    • Geelong, Victoria, Australia, 3220
      • Geelong Cardiology Research Unit, Barwon Health
    • Heidelberg Heights, Victoria, Australia, 3081
      • Austin Health - Heidelberg Repatriation Hospital, Department of Medicine, Boronia Centre
    • Saint Kilda East, Victoria, Australia, 3183
      • Avenue Cardiovascular Centre
  • Western Australia
    • Joondalup, Western Australia, Australia, 6027
      • Joondalup Cardiovascular Trials Foundation Inc
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital, Cardiology Research Department,CDO11
• Bahamas
  • Nassau, Bahamas
    • The Partners Clinical Research Centre
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2H 2G4
      • LMC Clinical Research Inc. (Calgary)
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Gordon and Leslie Diamond Health Care Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Nova Scotia Health Authority /QEII Health Sciences Centre
  • Ontario
    • Brampton, Ontario, Canada, L6S0C9
      • LMC Diabetes & Endocrinology - Brampton
    • Brampton, Ontario, Canada, L6Z 4N5
      • McMaster University
    • Burlington, Ontario, Canada, L7M 4Y1
      • JBN Medical Diagnostic Services Inc.
    • Burlington, Ontario, Canada, L7R 1E2
      • Aviva Clinical Trial Group In.
    • Cambridge, Ontario, Canada, N1R 6V6
      • Cambridge Cardiac Care Centre
    • Cambridge, Ontario, Canada, N1R 7L6
      • Joanne F. Liutkus Medicine Professional Corp.
    • Cambridge, Ontario, Canada, N1R 7R1
      • Saul Vizel Professional Medicine Corporation, Vizel Cardiac Research
    • Etobicoke, Ontario, Canada, M9R4E1
      • LMC Diabetes & Endocrinology (Etobicoke)
    • Hamilton, Ontario, Canada, L8L 5G8
      • Wharton Medical Clinic Clinical Trials Group Inc.
    • London, Ontario, Canada, N6A 4V2
      • Saint Josephs Health Care London
    • Markham, Ontario, Canada, L6B0P9
      • LMC Diabetes & Endocrinoly
    • Newmarket, Ontario, Canada, L3Y 8C3
      • New Market Cardiology Research Group
    • Oakville, Ontario, Canada, L6K 3W7
      • Dr. Michael Heffernan
    • Oakville, Ontario, Canada, L6M 4H8
      • LMC Clinical Research Inc. (Oakville)
    • Oshawa, Ontario, Canada, L1J 2K1
      • Dr. Cha
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute
    • Peterborough, Ontario, Canada, K9J 0B2
      • Kawartha Cardiology Clinical Trials
    • Sudbury, Ontario, Canada, P3E 6C3
      • Dr. Dinkar Shukla Professional Medicine Corporation
    • Sudbury, Ontario, Canada, P3E3B8
      • Dr Roger Labonte Professional Medicine Corp
    • Thornhill, Ontario, Canada, L4J8L7
      • Lmc Diabetes & Endocrinology (Thornhill)
    • Toronto, Ontario, Canada, M4G 3E8
      • LMC Clinical Research Inc. (Bayview)
    • Toronto, Ontario, Canada, M3M 3E5
      • Keele Medical Place
    • Toronto, Ontario, Canada, M3J 1N2
      • JJ DIG Research Ltd.
    • Toronto, Ontario, Canada, M5C 2T2
      • St Michael's Hospital Health Centre
  • Quebec
    • Brossard, Quebec, Canada, J4X 1S4
      • Viacar Recherche Clinique
    • Gatineau, Quebec, Canada, J8Y 6S8
      • Q&T Research Outaouais Inc.
    • Greenfield Park, Quebec, Canada, J4V 2G8
      • Viacar Recherche Clinique Inc.
    • Levis, Quebec, Canada, G6W 0M6
      • Manna Research Inc
    • Montreal, Quebec, Canada, H1T 3Y7
      • Clinique Sante Cardio MC
    • Quebec City, Quebec, Canada, G1V 4G5
      • Universitaire de Cardiologie et de Pneumologie de Quebec
    • Saint-Charles-Borromee, Quebec, Canada, J6E 6J2
      • Centre hospitalier régional de Lanaudière
    • Sherbrooke, Quebec, Canada, J1J 2E3
      • Recherche Clinique London
    • St Jean sur Richelieu, Quebec, Canada, J3A1C3
      • CardioVasc HR, Inc.
    • St-Lambert, Quebec, Canada, J4P 2H4
      • Viacar Recherche Clinique Inc.
    • Ville Saint-Laurent, Quebec, Canada, H4T 1Z9
      • LMC Clinical Research Inc. (Montreal)
• Chile
  • Concepcion, Chile, 4070038
    • Hospital Regional Concepción
  • Santiago, Chile, 7500520
    • Cardiocob
  • Santiago, Chile, 7500710
    • Servicios Medicos Godoy Ltda.
  • Santiago, Chile, 8331143
    • Ccbr Cecim
  • Temuco, Chile, 4781156
    • Centro Investigacion Clinica Del Sur
  • Temuco, Chile, 4813299
    • CECMI Ltda.
  • Santiago
    • Providencia, Santiago, Chile, 7500710
      • BioMedica Research Group
    • San Miguel, Santiago, Chile, 8910259
      • Sociedad Medica Cardiologica El Llano
• Mexico
  • Aguascalientes, Mexico, 20230
    • Hospital Cardiologica Aguascalientes
  • Aguascalientes, Mexico, 20230
    • Fundacion Cardiovascular de Aguascalientes
  • Distrito Federal, Mexico, 06700
    • Mentrials S.A.de C.V.
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44600
      • ICLE
    • Guadalajara, Jalisco, Mexico, 44657
      • Private Medical Practice
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64620
      • Centro de Estudios Clínicos y Especialidades Médicas S.C.
    • Monterrey, Nuevo Leon, Mexico, 64020
      • IMED Clin Trials
    • Monterrey, Nuevo Leon, Mexico, 64060
      • Cardiolink ClinTrials S.C.
  • Veracruz
    • Xalapa, Veracruz, Mexico, 91193
      • Hospital de Angeles Xalapa
• New Zealand
  • Auckland, New Zealand, 1148
    • Auckland City Hospital
  • Hastings, New Zealand, 4120
    • Hawkes Bay Regional Hospital
  • Nelson, New Zealand, 7010
    • Nelson Hospital, Cardiology Department
  • Rotorua, New Zealand, 3010
    • Lakeland Clinical Trials, Rotorua
  • Tauranga, New Zealand, 3112
    • Tauranga Hospital
  • Auckland
    • Milford, Auckland, New Zealand, 0622
      • North Shore Hospital-Cardiology Research
    • Papatoetoe, Auckland, New Zealand, 2025
      • Middlemore Hospital
    • Takapuna, Auckland, New Zealand, 0740
      • North Shore Hospital - Diabetes Clinic
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • Christchurch Hospital, Lipids
    • Christchurch, Canterbury, New Zealand, 8811
      • Christchurch Hospital, Cardiology Research
  • Otago
    • Dunedin, Otago, New Zealand, 9016
      • Dunedin Hospital
  • Taranaki
    • New Plymouth, Taranaki, New Zealand, 4310
      • Taranaki Base Hospital
  • Wellington
    • Lower Hutt, Wellington, New Zealand, 5010
      • Hutt Hospital, Cardiology Dept
• Poland
  • Bezrzecze, Poland, 72-003
    • Indywidualna Specjalistyczna Praktyka Lekarska
  • Biala Rawska, Poland, 96-230
    • NZOZ "Eskulap"
  • Białystok, Poland, 15-875
    • Podlaski Osrodek Kardiologii Janusz Korecki
  • Bydgoszcz, Poland, 85-681
    • 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
  • Bydgoszcz, Poland, 85-231
    • Centrum Medyczne Kermed
  • Chorzów, Poland, 41-500
    • Nzoz "Mada-Med"
  • Chrzanów, Poland, 32-500
    • DIABET Centrum Medyczne s. c.
  • Gdynia, Poland, 81-157
    • ISPL w Dziedzinie Kardiologii lek.med. Krzysztof Cymerman
  • Gdynia, Poland, 81-423
    • NZOZ SCBK ProCordis
  • Gdynia, Poland, 81-472
    • Gabinet Kardiologiczno-Internistyczny
  • Inowroclaw, Poland, 88-100
    • Praktyka Lekarska dr n. med. Marek Bronisz
  • Kamieniec Ząbkowicki, Poland, 57-230
    • Piotr Mader Diabetic Clinic NZOZ PD-I
  • Koluszki, Poland, 95-040
    • NZOZ Eskulap SC
  • Kraków, Poland, 30-082
    • Ewa Mirek-Bryniarska Specjalistyczna Praktyka Lekarska
  • Kraków, Poland, 31-156
    • LANDA' Specjalistyczne Gabinety Lekarskie
  • Kraków, Poland, 31-261
    • Medyczne Centrum Diabetologiczno Endokrynologiczno
  • Legnica, Poland, 59-220
    • Nzoz Cardiamed
  • Lublin, Poland, 20-044
    • "CenterMed Lublin" Sp. z o.o.
  • Mrągowo, Poland, 11-700
    • Indywidualna Praktyka Lekarska
  • Olsztyn, Poland, 10-010
    • Zechowicz MEDEUSZ-PLUS
  • Poznań, Poland, 61-655
    • Praktyka Lekarska Ewa Krzyzagorska
  • Poznań, Poland, 61-853
    • NZOZ NEURO-KARD "Ilkowski i Partnerzy"
  • Płock, Poland, 09-402
    • Specjalistyczna Przychodnia Lekarska MEDIKARD (SPL Medikard)
  • Tarnów, Poland, 33-100
    • Specjalistyczny Gabinet Lekarski
  • Toruń, Poland, 87-100
    • Lecznice Citomed Sp. z o.o.
  • Toruń, Poland, 87-100
    • Praktyka Lekarska Pawlowicz Lidia
  • Warszawa, Poland, 01-518
    • Centrum Medyczne AMED
  • Warszawa, Poland, 02-679
    • Centrum Badawcze Wspolczesnej Terapii
  • Warszawa, Poland, 03-973
    • SNZOZ Fundacji PROCLINICA
  • Wierzchosławice, Poland, 33-122
    • Centrum Zdrowia Wierzchoslawice
  • Wroclaw, Poland, 50-127
    • Regionalna Poradnia Diabetologiczna
  • Włocławek, Poland, 87-800
    • Specjalistyczne Gabinety Lekarskie "Medicor PLUS"
  • Łódź, Poland, 94-048
    • NZOZ All-Med Centrum Medyczne
  • Łęczna, Poland, 21-010
    • SP ZOZ w Lecznej
• United States
  • Alabama
    • Alexander City, Alabama, United States, 35010
      • Advanced Cardiovascular, LLC
    • Athens, Alabama, United States, 35611
      • North Alabama Research Center, LLC
    • Birmingham, Alabama, United States, 35294
      • UAB Medical Center
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc.
    • Mobile, Alabama, United States, 36608
      • Mobile Heart Specialists, PC
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Heart Institute
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Connect Clinical Research Center, LCC
    • Glendale, Arizona, United States, 85306
      • Arrowhead Health Centers
    • Glendale, Arizona, United States, 85306
      • Phoenix Heart, PLLC
    • Tucson, Arizona, United States, 85745
      • Eclipse Clinical Research
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners
    • Little Rock, Arkansas, United States, 72205
      • Central Arkansas Veterans Healthcare System
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Cardiology Clinic
  • California
    • Alhambra, California, United States, 91801
      • Clinical Research Alliance
    • Bakersfield, California, United States, 93308
      • Central Cardiology
    • Beverly Hills, California, United States, 90210
      • Cardiovascular Research Foundation of Southern Cal
    • Carmichael, California, United States, 95608
      • Capitol Interventional Cardiology
    • Chula Vista, California, United States, 91911 3813
      • San Diego Costal Endocrinology Group AMC
    • Concord, California, United States, 94520
      • John Muir Physician Network Clinical Research Cent
    • Encino, California, United States, 91436
      • Medical Group of Encino
    • Greenbrae, California, United States, 94904
      • Marin Endocrine Care & Research, Inc.
    • Huntington Beach, California, United States, 92648
      • California Heart Specialists
    • Huntington Park, California, United States, 90255
      • Del Rosario Medical Clinic, Inc.
    • La Mesa, California, United States, 91942
      • Diabetes and Endocrine Associates
    • La Mesa, California, United States, 91942
      • La Mesa Cardiac Center
    • Laguna Hills, California, United States, 92653
      • Alliance Research Centers
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute, Inc.
    • Long Beach, California, United States, 90807
      • Long Beach Center For Clinical Research
    • Los Angeles, California, United States, 90033
      • Metabolic Clinic and Research Center
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Health Care System
    • Los Angeles, California, United States, 90067
      • Beverly Hills Cardiology
    • Mission Viejo, California, United States, 92692
      • Clinical Interventions Research Institute
    • Murrieta, California, United States, 92563
      • Brigid Freyne MD Inc
    • Northridge, California, United States, 91325
      • Valley Clinical Trials Inc
    • Oceanside, California, United States, 92056
      • Carr Cardiology
    • Redding, California, United States, 96001
      • Northern California Clinical Research Center
    • San Diego, California, United States, 92103
      • University Of California San Diego
    • San Diego, California, United States, 92101
      • Sharp Rees-Stealy Medical Group, Inc.
    • San Diego, California, United States, 92117
      • Ritchken and First MD's
    • San Ramon, California, United States, 94582
      • West Coast Research LLC
    • Santa Ana, California, United States, 92704
      • Coastal Multi-Specialty Research
    • Thousand Oaks, California, United States, 91360
      • Westlake Medical Research
    • Torrance, California, United States, 90509
      • Harbor - UCLA Medical Center
    • Ventura, California, United States, 93003
      • Ventura Cardiology Consultants
    • Ventura, California, United States, 93003
      • Ronald Chochinov, MD
    • West Hills, California, United States, 91307
      • Infosphere Clinical Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • UCH-MHS Cardiac Research
    • Denver, Colorado, United States, 80209
      • Creekside Endocrine Associates PC
    • Golden, Colorado, United States, 80401
      • New West Physicians, PC
    • Loveland, Colorado, United States, 80538
      • University of Colorado Health
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
    • Bridgeport, Connecticut, United States, 06606
      • Connecticut Clinical Research, Llc
    • Bristol, Connecticut, United States, 06010-5103
      • Clinical Research Works, Bristol
    • Norwalk, Connecticut, United States, 06851
      • Cardiology Associates of Fairfield County, Norwalk
    • Stamford, Connecticut, United States, 06905
      • Stamford Therapeutics Consortium
    • Stamford, Connecticut, United States, 06905
      • Cardiology Associates of Fairfield County, P.C.
    • Trumbull, Connecticut, United States, 06611
      • Cardiology Associates of Fairfield County, P.C.
    • Trumbull, Connecticut, United States, 06611
      • Connecticut Heart and Vascular Center
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Delaware
    • Newark, Delaware, United States, 19713
      • Red Clay Research
    • Wilmington, Delaware, United States, 19803-3733
      • Alfieri Cardiology
  • Florida
    • Aventura, Florida, United States, 33180
      • Aventura Heart Center
    • Boynton Beach, Florida, United States, 33427
      • Zasa Clinical Research
    • Bradenton, Florida, United States, 34201
      • Meridien Research
    • Bradenton, Florida, United States, 34209
      • Nova Southeastern University
    • Brandon, Florida, United States, 33511
      • Bay Area Cardiology
    • Brooksville, Florida, United States, 34601
      • Meridien Research, Brooksville
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular and Interventional Cons.
    • Coral Gables, Florida, United States, 33143
      • Clinical Research of South Florida
    • Coral Springs, Florida, United States, 33065
      • Holy Cross Medical Group
    • Daytona Beach, Florida, United States, 32117
      • International Medical Research
    • Daytona Beach, Florida, United States, 32117
      • Cardiology Research Associates
    • Doral, Florida, United States, 33166
      • Asclepius Medical Research
    • Fleming Island, Florida, United States, 32003
      • Fleming Island Center for Clinical Research
    • Fort Lauderdale, Florida, United States, 33316
      • M & O Clinical Research, LLC
    • Fort Lauderdale, Florida, United States, 33312
      • Integrative Research Associates, Inc.
    • Fort Myers, Florida, United States, 33907
      • Primary Care Associates
    • Gainesville, Florida, United States, 32605
      • Florida Research Network, LLC
    • Green Cove Springs, Florida, United States, 32043
      • George E. Platt, M.D.
    • Hialeah, Florida, United States, 33013
      • Eastern Research, Inc.
    • Hollywood, Florida, United States, 33021
      • Research Physicians Network Alliance
    • Hollywood, Florida, United States, 33021
      • Larry K. Levinson, D.O., P.A.
    • Hudson, Florida, United States, 34667
      • Pasco Cardiology Center
    • Inverness, Florida, United States, 34452
      • Nature Coast Clinical Research
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Jacksonville, Florida, United States, 32209
      • University of Florida- Jacksonville
    • Jacksonville, Florida, United States, 32216
      • Westside Center for Clinical Research
    • Lakeland, Florida, United States, 33805
      • Meridien Research
    • Miami, Florida, United States, 33173
      • Cardiovascular Research Center of South Florida
    • Miami, Florida, United States, 33134
      • Life Spring Research Foundation
    • Miami, Florida, United States, 33126-2956
      • Pharmax Research Clinic, Inc
    • Miami, Florida, United States, 33155
      • United Clinical Research Corp.
    • Miami, Florida, United States, 33176
      • South Florida Research Group LLC
    • Miramar, Florida, United States, 33025
      • South Florida Research Solutions
    • Naples, Florida, United States, 34102
      • Southwest Florida Research
    • Ocala, Florida, United States, 34471
      • Ocala Research Institute, Inc
    • Oviedo, Florida, United States, 32765
      • Oviedo Medical Research
    • Palm Beach Gardens, Florida, United States, 33410-4304
      • Cardiology Partners Clinical Research Institute
    • Palm Beach Gardens, Florida, United States, 33410
      • Palm Beach Gardens Research Center
    • Pembroke Pines, Florida, United States, 33028
      • South Florida Research Solutions
    • Pembroke Pines, Florida, United States, 33025
      • Research Physicians Network Alliance, Pembrok
    • Pensacola, Florida, United States, 32501 6335
      • Cardiology Consultants
    • Plant City, Florida, United States, 33563
      • Clinical Research of Central Florida
    • Plantation, Florida, United States, 33324
      • Columbia Primary Care, LLC d/b/a Heart and Health Institute
    • Ponte Vedra, Florida, United States, 32081
      • St Johns Center for Clinical Research
    • Port Charlotte, Florida, United States, 33952
      • Charlotte Heart Group Research Center
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Rockledge, Florida, United States, 32955
      • Brevard Cardiovascular Research Associates Inc
    • Safety Harbor, Florida, United States, 34695
      • Clearwater Cardiovascular and Interventional Cons.
    • Saint Petersburg, Florida, United States, 33709
      • Meridien Research - St. Petersburg
    • Saint Petersburg, Florida, United States, 33701
      • Bayfront Health St. Petersburg, Research
    • Saint Petersburg, Florida, United States, 33713
      • Professional Health Care of Pinellas, INC
    • Sarasota, Florida, United States, 34239
      • Intercoastal Medical Group
    • Springfield, Florida, United States, 32401
      • Springfield Medical Center
    • Stuart, Florida, United States, 34996
      • Advanced Clinical Research Group
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
    • Tampa, Florida, United States, 33614
      • Healthpoint Medical Group, Inc
    • Tampa, Florida, United States, 33606
      • Meridien Research - Tampa
    • Trinity, Florida, United States, 34655
      • Interventional Cardiac Consultants
    • Venice, Florida, United States, 34292
      • Lovelace Scientific Research
    • Vero Beach, Florida, United States, 32960-3296
      • Indian River Medical Center-Cardiology
    • Wellington, Florida, United States, 33449
      • Cardiology Partners Clinical Research Institute
    • West Palm Beach, Florida, United States, 33401
      • Metabolic Research Institute
    • West Palm Beach, Florida, United States, 33401
      • Cleveland Clinic Foundation
    • Winter Haven, Florida, United States, 33880
      • Clinical Research of Central Florida
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates, Endocrinology
    • Conyers, Georgia, United States, 30094
      • Rockdale Medical-Research Associates
    • Cumming, Georgia, United States, 30041
      • Atlanta Heart Specialists
    • Marietta, Georgia, United States, 30067
      • Urban Family Practice Associates/Clinical Research Advantage
    • Roswell, Georgia, United States, 30076
      • Endocrine Research Solutions, Inc.
    • Suwanee, Georgia, United States, 30024
      • Herman Clinical Research LLC
    • Tucker, Georgia, United States, 30084
      • Atlanta Heart Specialists
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Heart Clinical Research, LLC
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
    • Chicago, Illinois, United States, 60607
      • Cedar-Crosse Research Center
    • Elmhurst, Illinois, United States, 60126
      • Consultants in Cardiovascular Medicine
    • Gurnee, Illinois, United States, 60031
      • Clinical Investigation Specialists, Inc. in Gurnee
    • Rock Island, Illinois, United States, 61201
      • Advanced CardioVascular Consultants, SC
  • Indiana
    • Anderson, Indiana, United States, 46011
      • Community Clinical Research Center
    • Avon, Indiana, United States, 46123
      • American Health Network of IN, LLC, Avon
    • Bloomington, Indiana, United States, 47403 3239
      • Premier Healthcare, Llc
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic, Inc.
    • Franklin, Indiana, United States, 46131
      • American Health Network of IN, LLC, Franklin
    • Greenfield, Indiana, United States, 46140
      • American Health Network of IN, LLC, Greenfield
    • Indianapolis, Indiana, United States, 46254-5471
      • American Health Network - Thomas Moretto, MD
    • Muncie, Indiana, United States, 47304
      • American Health Network of IN, LLC
    • Muncie, Indiana, United States, 47303
      • Medical Consultants PC
    • Munster, Indiana, United States, 46321
      • Cardiology Associates of Northwest Indiana, P.C
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • The University of Iowa, College of Public Health
  • Kansas
    • Wichita, Kansas, United States, 67203
      • Professional Research Network of Kansas, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
    • Louisville, Kentucky, United States, 40205 3338
      • Norton Heart Specialists
    • Louisville, Kentucky, United States, 40205-3338
      • Norton Heart Specialists
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity LLC
  • Maine
    • Auburn, Maine, United States, 04210
      • Central Maine Medical Center
    • Bangor, Maine, United States, 04401
      • Acadia Clinical Research, LLC
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center Northeast Cardiology Associates
    • Biddeford, Maine, United States, 04005
      • Southern Maine Health Care/Maine Medical Center Research Ins
    • Portland, Maine, United States, 04101
      • Intermed, PA
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Medstar Cardiology Associates
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
    • Baltimore, Maryland, United States, 21236
      • Overlea Personal Physicians
    • Baltimore, Maryland, United States, 21218
      • Medstar Union Memorial Heart Specialists
    • Baltimore, Maryland, United States, 21204
      • Chesapeake Cardiovascular Associates, GBMC
    • Baltimore, Maryland, United States, 21204
      • Clinical Research, Inc
    • Baltimore, Maryland, United States, 21229
      • Spectrum Clinical Research
    • Baltimore, Maryland, United States, 21237
      • Shahid Saeed MD, PC
    • Glen Burnie, Maryland, United States, 21061
      • Maryland Heart Associates, LLC
    • Hagerstown, Maryland, United States, 21740
      • Klein & Associates, MD, PA
    • Hyattsville, Maryland, United States, 20782
      • MedStar Health Research Institute
    • Lutherville, Maryland, United States, 21093
      • Lutherville Personal Physicians
    • Oxon Hill, Maryland, United States, 20745
      • MD Medical Research
    • Rockville, Maryland, United States, 20852
      • Endocrine & Metabolic Consultants
    • Towson, Maryland, United States, 21204
      • Lutherville Personal Physicians
    • Towson, Maryland, United States, 21204
      • Overlea Personal Physicians
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02114
      • MGH Weight Center
    • Fall River, Massachusetts, United States, 02720
      • New England Center for Clinical Research, IMCA
    • Haverhill, Massachusetts, United States, 01830
      • Pentucket Medical Associates
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices
    • Natick, Massachusetts, United States, 01760
      • Partners Community Physicians Organization
    • Needham, Massachusetts, United States, 02494
      • Partners Community Physicians Organization
  • Michigan
    • Alpena, Michigan, United States, 49707
      • Endeavor Medical Research PLC
    • Cadillac, Michigan, United States, 49601
      • Cadillac Clinical Research, LLC
    • Kalamazoo, Michigan, United States, 49009
      • Westside Family Medical Center, Pc
    • Lapeer, Michigan, United States, 48446
      • Cardiology Consultants of East Michigan
    • Marquette, Michigan, United States, 49855
      • Marquette General Heart and Vascular Institute
    • Midland, Michigan, United States, 48670
      • MidMichigan Medical Center
    • Petoskey, Michigan, United States, 49770
      • Nisus Research at McLaren Northern Michigan Hospital
    • Pontiac, Michigan, United States, 48341-2985
      • Saint Joseph Mercy Oakland Hospital
    • Rochester, Michigan, United States, 48307
      • Remedica LLC
    • Saginaw, Michigan, United States, 48601 1423
      • Michigan Cardiovascular Institute
    • Southfield, Michigan, United States, 48034
      • American Center for Clinical Trials
    • Traverse City, Michigan, United States, 49684-2386
      • Medical Research Associates, Inc.
    • Ypsilanti, Michigan, United States, 48197
      • Michigan Heart
  • Minnesota
    • Baxter, Minnesota, United States, 56425
      • Minneapolis Heart Institute Foundation
    • Duluth, Minnesota, United States, 55805
      • Essentia Institute of Rural Health
    • Eagan, Minnesota, United States, 55123
      • MNCOME Clinic
    • Edina, Minnesota, United States, 55435
      • Radiant Research, Inc.
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital
  • Mississippi
    • Gulfport, Mississippi, United States, 39501
      • Coast Cardiovascular Consultants PLLC
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates Research, LLC
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Diabetes & Endocrinology Specialists, Inc.
    • Washington, Missouri, United States, 63090
      • BodyAesthetic Research Center
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic Research Center
    • Billings, Montana, United States, 59102
      • Montana Health Research Institute, Inc.
    • Kalispell, Montana, United States, 59901
      • Glacier View Cardiology PC
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Internal Medical Associates of Grand Island, PC
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Clinical Research Advantage / Rita Chuang, M.D.
    • Las Vegas, Nevada, United States, 89121
      • Clinical Research of South Nevada
    • Las Vegas, Nevada, United States, 89117
      • Clinical Research Advantage, Inc.
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807-3060
      • Medicor Cardiology, PA
    • Bridgewater, New Jersey, United States, 08807
      • Advanced Heart Care
    • East Brunswick, New Jersey, United States, 08816
      • UmiMed Center LLC
    • Elmer, New Jersey, United States, 08318-1715
      • Cardiovascular Associates of the Delaware Valley
    • Haddon Heights, New Jersey, United States, 08035
      • Advocare Heights Primary Care
    • Haddon Heights, New Jersey, United States, 08035
      • Cardiovascular Associates of the Delaware Valley P
    • Linden, New Jersey, United States, 07036
      • NJ Heart
    • Mine Hill, New Jersey, United States, 07103
      • Rutgers New Jersey Medical School
    • Sewell, New Jersey, United States, 08080-1715
      • Cardiovascular Associates Delaware Valley Sewell
    • Somerset, New Jersey, United States, 08873
      • Cardio Metabolic Institute
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute, PA
  • New York
    • Albany, New York, United States, 12211
      • Capital Cardiology Associates
    • Albany, New York, United States, 12206
      • Albany College of Medicine, Division of Endocrinology
    • Binghamton, New York, United States, 13901
      • United Medical Associates, PC
    • Bronx, New York, United States, 10468
      • James J. Peters VA Medical Center, Bronx, NY
    • Buffalo, New York, United States, 14215
      • Buffalo Heart group
    • Endwell, New York, United States, 13760
      • Regional Clinical Research, Inc.
    • Great Neck, New York, United States, 11023
      • Long Island Gastrointestinal Research Group LLP
    • Mineola, New York, United States, 11501
      • Long Island Heart Associates
    • New Hyde Park, New York, United States, 11042
      • North Shore Diabetes and Endocrine Associates
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • North Massapequa, New York, United States, 11758
      • Digiovanna Institute For Medical Education
    • Poughkeepsie, New York, United States, 12601
      • Hudson Valley Heart Center
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
    • Southampton, New York, United States, 11968
      • Northwell Health Physician Partners Cardiology
    • Troy, New York, United States, 12180
      • Capital Cardiology Associates
    • Westfield, New York, United States, 14787
      • Great Lakes Medical Research
  • North Carolina
    • Burlington, North Carolina, United States, 27215
      • Kernodle Clinic
    • Cary, North Carolina, United States, 27518
      • Clinical Trials of America Inc.
    • Charlotte, North Carolina, United States, 28209
      • PMG Research of Charlotte, LLC
    • Charlotte, North Carolina, United States, 28204
      • Metrolina Internal Medicine
    • Greensboro, North Carolina, United States, 27401
      • Bland Clinic, PA
    • Hickory, North Carolina, United States, 28601
      • Clinical Trials of America, Inc.
    • Hickory, North Carolina, United States, 28601
      • Clinical Trials of America Inc. Hickory
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research
    • Lenoir, North Carolina, United States, 28645
      • Clinical Trials of America, Inc.
    • Morehead City, North Carolina, United States, 28557
      • Diabetes & Endocrinology Consultants
    • Morganton, North Carolina, United States, 28655
      • Burke Primary Care
    • Pinehurst, North Carolina, United States, 28374-8798
      • Pinehurst Medical Clinic, INC.
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
    • Rocky Mount, North Carolina, United States, 27804
      • PMG Research of Rocky Mount
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury
    • Sanford, North Carolina, United States, 27330
      • Sanford Cardiology
    • Statesville, North Carolina, United States, 28625
      • Piedmont Healthcare
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem, LLC
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Lillestol Research LLC
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Research Center
    • Cincinnati, Ohio, United States, 45236
      • Sentral Clinical Research
    • Delaware, Ohio, United States, 43015
      • Delaware Research Group, LLC
    • Marion, Ohio, United States, 43302
      • Awasty Research Network, LLC
    • Massillon, Ohio, United States, 44646
      • Community Health Care
    • Springfield, Ohio, United States, 45505
      • Apex Medical Research Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Memorial Clinical Research
    • Oklahoma City, Oklahoma, United States, 73135
      • South Oklahoma Heart Research, LLC
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Cardiovascular Physicians LLC
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
    • Tulsa, Oklahoma, United States, 74136 7028
      • Vital Prospects Clinical Research Institute PC
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Clinical Research Associates of Central PA, LLC
    • Altoona, Pennsylvania, United States, 16602
      • Blair Medical Associates
    • Camp Hill, Pennsylvania, United States, 17011
      • Capital Area Research, LLC
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Health System
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Health Clinic
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Health Cardiology a Division of Doylestown Health
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
    • Erie, Pennsylvania, United States, 16508
      • Liberty Family Practice
    • Feasterville, Pennsylvania, United States, 19053
      • Endocrine Clinical Research LLC
    • Indiana, Pennsylvania, United States, 15701
      • Joseph Lamantia, DO
    • Jenkintown, Pennsylvania, United States, 19046
      • The Clinical Trial Center, LLC
    • Jersey Shore, Pennsylvania, United States, 17740
      • Lycoming Internal Medicine, Inc.
    • Johnstown, Pennsylvania, United States, 15905-3443
      • Berkley Hills Clinicals
    • Johnstown, Pennsylvania, United States, 15905
      • Ilumina Clinical Associates, Johnstown
    • Johnstown, Pennsylvania, United States, 15905
      • Joseph Lamantia, DO
    • Langhorne, Pennsylvania, United States, 19047
      • Comprehensive Cardiology Consultants
    • Lansdale, Pennsylvania, United States, 19446
      • Detweiler Family Medicine and Associates PC
    • Lansdale, Pennsylvania, United States, 19446
      • Green & Seidner Family Practice Associates
    • Newport, Pennsylvania, United States, 17074
      • Capital Area Research LLC
    • Philadelphia, Pennsylvania, United States, 19114
      • Endocrine Metabolic Associates
    • Pottstown, Pennsylvania, United States, 19464
      • Pottstown Medical Specialists, Inc. (PMSI)
    • Scranton, Pennsylvania, United States, 18508
      • Geisinger Clinic
  • Rhode Island
    • Cumberland, Rhode Island, United States, 02864
      • Partners in Clinical Research
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • Radiant Research, Inc.
    • Greer, South Carolina, United States, 29651
      • Mountain View Clinical Research
    • Spartanburg, South Carolina, United States, 29302
      • Palmetto Research Center, LLC
  • South Dakota
    • Watertown, South Dakota, United States, 57201
      • Brown Clinic, PLLP
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • PMG Research of Bristol, LLC
    • Chattanooga, Tennessee, United States, 37421
      • WR-Clinsearch, LLC
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Research and Medicine (CHARM)
    • Greeneville, Tennessee, United States, 37745-5810
      • Wellmont CVA Heart Institute
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic, PA
    • Jackson, Tennessee, United States, 38305
      • Kore Cardiovascular Research
    • Jackson, Tennessee, United States, 38301-3930
      • Research Associates Of Jackson
    • Johnson City, Tennessee, United States, 37604
      • Wellmont CVA Heart Institute
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
    • Kingsport, Tennessee, United States, 37660
      • Wellmont CVA Heart Institute
    • Memphis, Tennessee, United States, 38119
      • The Endocrine Clinic
    • Nashville, Tennessee, United States, 37203
      • Cardiology Wellness Center
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Diabetes & Endocrinology
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research, LLC
    • Carrollton, Texas, United States, 75007
      • Texas Health Physicians Group
    • Corpus Christi, Texas, United States, 78404
      • Adriana Pop-Moody MD Clinic, PA
    • Dallas, Texas, United States, 75231
      • Research Institute Of Dallas
    • Dallas, Texas, United States, 75218
      • Texas Health Physicians Group
    • Dallas, Texas, United States, 75024
      • Baylor Research Institute
    • Dallas, Texas, United States, 75220
      • Texas Health Physicians Group, Dallas
    • Fort Worth, Texas, United States, 76104
      • Odilon Alvarado, M.D.
    • Fort Worth, Texas, United States, 76107
      • Texas Health Physicians Group Fort Worth
    • Fort Worth, Texas, United States, 76117
      • Tand R Clinic, PA
    • Georgetown, Texas, United States, 78626
      • San Gabriel Clinical Research, LLC
    • Houston, Texas, United States, 77095
      • Endocrine and Psychiatry Center
    • Houston, Texas, United States, 77074
      • Oxford Clinical Research, LLC
    • Houston, Texas, United States, 77025 5253
      • Angiocardiac Care of Texas PA
    • Houston, Texas, United States, 77094
      • West Houston Area Clinical Trial Consultants, LLC
    • Irving, Texas, United States, 75039
      • Texas Health Physicians Group
    • Kingwood, Texas, United States, 77339
      • Texas Cardiology Associates of Houston
    • Lewisville, Texas, United States, 75067
      • Jalil Aziz Khan M.D., P.A.
    • Midland, Texas, United States, 79707
      • Midland Clinical Research Center
    • Odessa, Texas, United States, 79761
      • Permian Research Foundation
    • Plano, Texas, United States, 75075
      • Clinical Investigations of Texas, LLC
    • Plano, Texas, United States, 75023
      • Medical Clinic of North Texas
    • Round Rock, Texas, United States, 78681
      • Texas Diabetes
    • San Antonio, Texas, United States, 78229
      • Cardiology Clinic of San Antonio
    • San Antonio, Texas, United States, 78229
      • Radiant Research San Antonio
    • San Antonio, Texas, United States, 78228
      • Physician PrimeCare Research Institute, PLLC
    • Tomball, Texas, United States, 77375
      • Martin Diagnostic Clinic
    • Tyler, Texas, United States, 75701
      • Cardiovascular Associates of East Texas
    • Webster, Texas, United States, 77598
      • Bay Area Total Health Medical Group
  • Utah
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Alexandria Clinical Research, LLC
    • Arlington, Virginia, United States, 22201
      • Washington Center for Weight Management and Resear
    • Burke, Virginia, United States, 22015
      • Burke Internal Medicine and Research
    • Danville, Virginia, United States, 24541
      • Cardiology Consultants of Danville, Inc.
    • Danville, Virginia, United States, 24541
      • Danville Internal Medicine, Inc
    • Falls Church, Virginia, United States, 22044
      • Seven Corners Medical Research Center
    • Falls Church, Virginia, United States, 22042-1262
      • Virginia Heart
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center
    • Manassas, Virginia, United States, 20109
      • Inova Health Care Services
    • Manassas, Virginia, United States, 20110
      • Burke Internal Medicine and Research
    • Norfolk, Virginia, United States, 23507
      • Clinical Research Associates of Tidewater
    • Norfolk, Virginia, United States, 23502
      • Health Research of Hampton Roads - Norfolk, Inc.
    • Richmond, Virginia, United States, 23229
      • Virginia Cardiovascular Specialists
    • Richmond, Virginia, United States, 23220
      • Clinical Research Partners
    • Richmond, Virginia, United States, 23294
      • National Clinical Research-Richmond, Inc
    • Winchester, Virginia, United States, 22601
      • Selma Medical Associates
  • Washington
    • Federal Way, Washington, United States, 98003
      • Larry D. Stonesifer, MD, Inc PS
    • Seattle, Washington, United States, 98105
      • Seattle Women's
    • Spokane, Washington, United States, 99218
      • Rowan Research Inc.
    • Tacoma, Washington, United States, 98405
      • Universal Research Group
    • Tacoma, Washington, United States, 98405
      • MultiCare Research Institute
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Hospital & Clinics
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Cardiology Associates of Bellin Health
    • Green Bay, Wisconsin, United States, 54303
      • Prevea Clinic, Inc
    • Kenosha, Wisconsin, United States, 53142
      • Clinical Investigation Specialists, Inc.
    • Madison, Wisconsin, United States, 53713
      • Meriter hospital Inc., DBA: UnityPoint Health-Meriter Heart
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. BMI greater than or equal (>=) to 27 kilogram per meter square (kg/m^2)
2. Subjects able and willing to comply with a reduced-calorie diet and an increased physical activity program

3. Age >= to 40 years with established CV disease as defined by one of the following:

   1. History of documented MI or ischemic stroke
   2. History of peripheral artery disease
   3. History of revascularization (coronary, carotid, or peripheral artery)
   4. Significant unrevascularized coronary arterial stenosis

OR

Age >= to 55 years for women or >= to 50 years for men who have type 2 diabetes mellitus (T2DM) without established CV disease plus at least one of the following CV risk factors:

1. Hypertension, or currently receiving therapy for documented hypertension
2. Dyslipidemia, or currently taking prescription lipid-lowering therapy for documented dyslipidemia
3. Estimated glomerular filtration rate >= to 30 to less than equal (<=) to 60 mililitre per minute per 1.73 meter square (mL/min/1.73 m^) per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
4. High high sensitivity C-reactive protein (hsCRP)
5. Urinary albumin-to-creatinine ratio (ACR) >= 30 ug/mg

Subjects with T2DM may have a pre-existing or new diagnosis of T2DM. A new diagnosis of T2DM (ie, discovered at Screening) should be based on the 2013 American Diabetes Association (ADA) guidelines.

All T2DM subjects must have an HbA[1c] less (<) than 10% at Screening. If subjects are being treated, or upon diagnosis need to be treated with antidiabetic agents, the T2DM treatment regimen must be stable for at least 3 months prior to randomization.

Exclusion Criteria

1. Moderate or greater symptoms of congestive cardiac failure (New York Heart Association [NYHA] class III or IV)
2. Known left ventricular (LV) ejection fraction < than 20%
3. Moderate or greater symptoms of pulmonary hypertension (PH)
4. Known severe valvular disease
5. Moderate renal impairment, severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m^ per the CKD-EPI equation based on ideal body weight), or end stage renal disease (ESRD)
6. Severe hepatic impairment
7. Use of other products intended for weight loss including prescription drugs, over-the-counter (OTC) drugs, and herbal preparations
8. Use of more than one other serotonergic drug
9. Use of drugs known to increase the risk for cardiac valvulopathy within 6 months prior to Screening including, but not limited to: pergolide, ergotamine, methysergide, cabergoline
10. History or evidence of clinically significant disease (e.g., malignancy, cardiac, respiratory, gastrointestinal, renal or psychiatric disease)
11. Use of lorcaserin HCl prior to Screening or hypersensitivity to lorcaserin HCl or any of the excipients
12. Planned bariatric surgery
13. Females must not be breastfeeding or pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lorcaserin hydrochloride (HCL)10 mg; APD356 10 mg twice daily	Drug: Lorcaserin hydrochloride; APD356 10 mg twice daily; Other Names: APD356; BELVIQ
PLACEBO_COMPARATOR: Placebo; Placebo twice daily	Drug: Placebo; Placebo twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis	The MACE events involved myocardial infarction (MI), stroke, or cardiovascular (CV) death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.	Baseline up to Month 42
Time From Randomization to First Occurrence of MACE+	The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or heart failure (HF), or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.	Baseline up to end of study (Month 56)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Participants With Prediabetes at Baseline	Time from randomization to conversion to T2DM was defined as first occurrence of any component of the 2013 American Diabetes Association (ADA) Diagnostic Criteria (ADA, 2013) in participants with prediabetes at baseline. The diagnostic criteria were met if a participant had unequivocal hyperglycemia (random plasma glucose greater than or equal to (>=) 200 milligram per deciliter (mg/dL) (11.1 millimole per liter [mmol/L]) with classic symptoms of hyperglycemia or hyperglycemic crisis) or any of the following criteria were observed and subsequently confirmed on repeat laboratory testing such as: glycosylated hemoglobin (HbA1c) >=to 6.5%; fasting plasma glucose (FPG) >=126 mg/dL (7.0 mmol/L); 2-hour plasma glucose >=200 mg/dL (11.1 mmol/L) by an oral glucose tolerance test (OGTT). The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.	Baseline up to end of study (Month 56)
Time From Randomization to First Occurrence of the Individual Components of MACE+	The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or HF, or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.	Baseline up to end of study (Month 56)
Time From Randomization to Event of All-cause Mortality	The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.	Baseline up to end of study (Month 56)
Time From Randomization to Conversion to Normal Glucose Homeostasis in Participants With Prediabetes at Baseline	Normal glucose homeostasis was defined as HbA1c less than or equal to (<=) 5.6% and FPG < 100 mg/dL without any antidiabetic treatment. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.	Baseline up to end of study (Month 56)
Time From Randomization to Conversion to T2DM for Participants Without Any Type of Diabetes at Baseline	The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.	Baseline up to end of study (Month 56)
Change From Baseline in HbA1c at Month 6 in Participants With T2DM at Baseline		Baseline, and Month 6
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Participants	New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (albumin-to-creatinine ratio [ACR] >=30mcg/mg and ACR>=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at Baseline developed macroalbuminuria, ACR increased >=30% from Baseline during treatment), newly developed chronic kidney disease (CKD) (eGFR >=90 milliliter per minute per 1.73 [mL/min/1.73]body surface area (BSA) and without kidney damage at Baseline changed to CKD Stage 1/higher as per National Kidney Foundation [NKF] Guidelines [2002]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines [2002] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times Baseline value and >=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.	Baseline up to end of study (Month 56)
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With Prediabetes at Baseline	New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (ACR >=30mcg/mg and ACR >=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at baseline developed macroalbuminuria, ACR increased >=30% from baseline during treatment), CKD (eGFR >=90 mL/min/1.73 BSA and without kidney damage at baseline changed to CKD Stage 1/higher as per NKF Guidelines [2002]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines [2002] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times baseline value and >=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.	Baseline up to end of study (Month 56)
Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With T2DM at Baseline	New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (ACR >=30 mcg/mg and ACR >=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at baseline developed macroalbuminuria, ACR increased >=30% from baseline during treatment), CKD (eGFR >=90 mL/min/1.73 BSA and without kidney damage at baseline changed to CKD Stage 1/higher as per NKF Guidelines [2002]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines [2002] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times baseline value and >=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.	Baseline up to end of study (Month 56)
Time From Randomization to Event of Improvement in Renal Function in Participants With T2DM at Baseline	Improvement in renal function was defined as first occurrence of regression of albuminuria or regression of CKD. Regression of albuminuria was defined as when participants with macroalbuminuria at baseline developed microalbuminuria or nonalbuminuria (ACR <30 mcg/mg in spot urine), or participants with microalbuminuria at baseline became nonalbuminuric, and ACR value decreased >= 30% from previous assessment during treatment. Regression of CKD defined as when participants with CKD Stage 1 or higher at baseline improved to normal or lower stages by NKF guidelines (eGFR >=90 with albuminuria at baseline improved to eGFR >=90 without albuminuria, or eGFR 60 to 89 at baseline became eGFR >=90 with or without albuminuria, or eGFR between 30 to 59 at baseline improved to >60 mL/min/1.73 BSA) during treatment. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.	Baseline up to end of study (Month 56)
Percentage of Participants Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes		Months 6 and 12
Percentage of Participants With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy		Months 6 and 12
Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure		Baseline, Month 12

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Collaborators: Thrombolysis In Myocardial Infarction (TIMI) Academic Research Organization

Publications and helpful links

General Publications

• Scirica BM, Bohula EA, Dwyer JP, Qamar A, Inzucchi SE, McGuire DK, Keech AC, Smith SR, Murphy SA, Im K, Leiter LA, Gupta M, Patel T, Miao W, Perdomo C, Bonaca MP, Ruff CT, Sabatine MS, Wiviott SD; CAMELLIA-TIMI 61 Steering Committee and Investigators. Lorcaserin and Renal Outcomes in Obese and Overweight Patients in the CAMELLIA-TIMI 61 Trial. Circulation. 2019 Jan 15;139(3):366-375. doi: 10.1161/CIRCULATIONAHA.118.038341.
• Bohula EA, Scirica BM, Inzucchi SE, McGuire DK, Keech AC, Smith SR, Kanevsky E, Murphy SA, Leiter LA, Dwyer JP, Corbalan R, Hamm C, Kaplan L, Nicolau JC, Ophuis TO, Ray KK, Ruda M, Spinar J, Patel T, Miao W, Perdomo C, Francis B, Dhadda S, Bonaca MP, Ruff CT, Sabatine MS, Wiviott SD; CAMELLIA-TIMI 61 Steering Committee Investigators. Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial. Lancet. 2018 Nov 24;392(10161):2269-2279. doi: 10.1016/S0140-6736(18)32328-6. Epub 2018 Oct 4.
• Bohula EA, Wiviott SD, McGuire DK, Inzucchi SE, Kuder J, Im K, Fanola CL, Qamar A, Brown C, Budaj A, Garcia-Castillo A, Gupta M, Leiter LA, Weissman NJ, White HD, Patel T, Francis B, Miao W, Perdomo C, Dhadda S, Bonaca MP, Ruff CT, Keech AC, Smith SR, Sabatine MS, Scirica BM; CAMELLIA-TIMI 61 Steering Committee and Investigators. Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients. N Engl J Med. 2018 Sep 20;379(12):1107-1117. doi: 10.1056/NEJMoa1808721. Epub 2018 Aug 26.
• Bohula EA, Scirica BM, Fanola C, Inzucchi SE, Keech A, McGuire DK, Smith SR, Abrahamsen T, Francis BH, Miao W, Perdomo CA, Satlin A, Wiviott SD, Sabatine MS. Design and rationale for the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients-Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial. Am Heart J. 2018 Aug;202:39-48. doi: 10.1016/j.ahj.2018.03.012. Epub 2018 Mar 29.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 24, 2014
• Primary Completion (ACTUAL): May 14, 2018
• Study Completion (ACTUAL): May 14, 2018

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: December 18, 2013
• First Posted (ESTIMATE): December 24, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes; Obesity; Overweight; Cardiovascular Disease; MACE; Multiple Cardiovascular Risk Factors; Conversion to Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
• Other Study ID Numbers: APD356-G000-401; 2013-000324-34 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes