A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)

April 17, 2024 updated by: Eli Lilly and Company

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@Lilly.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1012
        • CONEXA Investigación Clínica S.A.
        • Contact:
          • Phone Number: 5491169680411
        • Principal Investigator:
          • María Florencia Scioscia
      • Córdoba, Argentina, 5000
        • Centro Diabetológico Dr. Waitman
        • Contact:
          • Phone Number: 549351424516
        • Principal Investigator:
          • Silvana Ernestina Solis
      • Córdoba, Argentina, X50004FHP
        • Clínica Universitaria Reina Fabiola
        • Contact:
          • Phone Number: 35196098294
        • Principal Investigator:
          • Silvina Patri Dominguez Matheu
      • Santa Fe, Argentina, 3000
        • Centro de Diagnóstico y Rehabilitación (CEDIR)
        • Contact:
          • Phone Number: 5493424087292
        • Principal Investigator:
          • Antonio Enrique Saleme
    • Ciudad Aut
      • C.a.b.a., Ciudad Aut, Argentina, C1205AAO
        • CEMEDIAB
        • Contact:
          • Phone Number: 549114405474
        • Principal Investigator:
          • Alejandro Mario Chertkoff
    • Ciudad Autónoma De Buenos Aire
      • Caba, Ciudad Autónoma De Buenos Aire, Argentina, 1204
        • Instituto Centenario
        • Contact:
          • Phone Number: 5491140783327
        • Principal Investigator:
          • SUSANA SALZBERG
    • Ciudad Autónoma De Buenos Aires
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1128AAF
        • Mautalen Salud e Investigación
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
        • Contact:
          • Phone Number: 543416928531
        • Principal Investigator:
          • Horacio Angel Sessa
      • Rosario, Santa Fe, Argentina, 2000
        • Instituto de Investigaciones Clinicas Rosario
        • Contact:
          • Phone Number: 54934133480
        • Principal Investigator:
          • Maximiliano Sicer
      • Venado Tuerto, Santa Fe, Argentina, 2600
        • Sanatorio San Martin
        • Contact:
          • Phone Number: 543462420042
        • Principal Investigator:
          • Oscar Gomez Vilamajo
    • Tucumán
      • SAN M. DE Tucuman, Tucumán, Argentina, T4000AXL
        • Centro de Investigaciones Médicas Tucuman
  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Optimus Clinical Research
      • Merewether, New South Wales, Australia, 2291
        • The AIM Centre / Hunter Diabetes Centre
        • Contact:
          • Phone Number: 61249632323
        • Principal Investigator:
          • Claire Morbey
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women'S Hospital
        • Contact:
          • Phone Number: 61736468111
        • Principal Investigator:
          • Donald Sout McLeod
      • Brisbane, Queensland, Australia, 4064
        • Core Research Group
        • Contact:
          • Phone Number: 61738765688
        • Principal Investigator:
          • David Martin Colquhoun
      • Meadowbrook, Queensland, Australia, 4131
        • Logan Hospital
        • Contact:
          • Phone Number: 0449062262
        • Principal Investigator:
          • Gaurav Puri
    • South Australia
      • Oaklands Park, South Australia, Australia, 5046
        • Southern Adelaide Diabetes & Endocrine Services
        • Contact:
          • Phone Number: 610874258690
        • Principal Investigator:
          • Stephen Neil Stranks
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
        • Principal Investigator:
          • Ming Li Yee
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research
        • Contact:
          • Phone Number: 0395096166
        • Principal Investigator:
          • King Chou Cheung
      • Heidelberg West, Victoria, Australia, 3081
        • Austin Health - Repatriation Hospital
        • Contact:
          • Phone Number: 0394962160
        • Principal Investigator:
          • Elif Ekinci
      • Melbourne, Victoria, Australia, 3004
        • Baker IDI Heart and Diabetes Institute - Melbourne
    • Western Australia
      • Joondalup, Western Australia, Australia, 6027
        • GenesisCare
  • Brazil
      • São Paulo, Brazil, 04266-010
        • Hospital das Clinicas FMUSP
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 71625-175
        • Centro de Pesquisa Clinica do Brasil
        • Contact:
          • Phone Number: 556133643364
        • Principal Investigator:
          • Joao Lindolfo Cunha Borges
    • Goiás
      • Goiânia, Goiás, Brazil, 74230-035
        • Cendi - Endocrinologia e Diabetes
        • Contact:
          • Phone Number: 5562992240229
        • Principal Investigator:
          • Nelson Rassi
    • Rio De Janeiro
      • Volta Redonda, Rio De Janeiro, Brazil, 27253-003
        • Instituto Lóbus
        • Principal Investigator:
          • Vicente Lopes da Silva Junior
    • Rio Grande Do Sul
      • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-120
        • Instituto Méderi de Pesquisa e Saúde
        • Contact:
          • Phone Number: 555435811831
        • Principal Investigator:
          • Hugo Roberto Kurtz Lisboa
    • São Paulo
      • Marília, São Paulo, Brazil, 17504-072
        • Centro de Pesquisa Clínica de Marília - CPCLIM
        • Contact:
          • Phone Number: 551421051477
        • Principal Investigator:
          • José Augusto Sgarbi
      • Santo André, São Paulo, Brazil, 09080-110
        • Pesquisare Saude
        • Contact:
          • Phone Number: 551144273339
        • Principal Investigator:
          • Rita de Cassia Pellegrini
  • China
    • Anhui
      • Hefei, Anhui, China, 230011
        • The Second People's Hospital of Hefei
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital
        • Principal Investigator:
          • Yiming Mu
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Chongqing General Hospital
        • Contact:
          • Phone Number: 8613983685857
        • Principal Investigator:
          • Hongman Wang
    • Guangdong
      • Shenzhen, Guangdong, China, 518020
        • ShenZhen People's Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The Fourth Hospital of Harbin Medical University
        • Contact:
          • Phone Number: 18903602198
        • Principal Investigator:
          • ZhiFeng Cheng
    • Henan
      • Luoyang Shi, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Zhengzhou, Henan, China, 450014
        • The Second Affiliated Hospital of Zhengzhou University
        • Contact:
          • Phone Number: 15838123695
        • Principal Investigator:
          • Qingju Li
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital
        • Principal Investigator:
          • Jianhua Ma
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
        • Principal Investigator:
          • Yibing Lu
        • Contact:
          • Phone Number: 18951762690
      • Nanjing, Jiangsu, China, 210008
        • Jiangsu Province Official Hospital
      • Nantong, Jiangsu, China, 226001
        • NanTong First People's Hospital
        • Principal Investigator:
          • Xueqin Wang
      • Wuxi, Jiangsu, China, 214023
        • Wuxi People's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial People's Hospital
    • Liaoning
      • Dalian, Liaoning, China, 116033
        • Dalian Municipal Central Hospital Affiliated Of Dalian Medical University
        • Contact:
          • Phone Number: 041184412001
        • Principal Investigator:
          • Xinyu Li
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
        • Contact:
          • Phone Number: 15318816218
        • Principal Investigator:
          • Xiaolin Dong
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital
        • Principal Investigator:
          • Ming Liu
        • Contact:
          • Phone Number: 18322017516
      • Tianjin, Tianjin, China
        • Tianjin Medical University Zhu Xianyi Memorial Hospital
        • Principal Investigator:
          • Liming Chen
    • Yunnan
      • Kunming, Yunnan, China, 650034
        • The First People's Hospital of Yunnan Province
        • Principal Investigator:
          • Heng Su
  • Czechia
      • Hradec Kralove, Czechia, 500 12
        • Endokrinologie MUDr. Rehorkova s.r.o.
        • Contact:
          • Phone Number: 420778071767
        • Principal Investigator:
          • Pavla Rehorkova
      • Plzen, Czechia, 326 00
        • MUDr. Jitka Zemanová - diabetologie a interna s.r.o.
        • Contact:
          • Phone Number: 0420602650556
        • Principal Investigator:
          • Jitka Zemanova
      • Český Krumlov, Czechia, 381 01
        • Nemocnice Cesky Krumlov
    • Jihočeský
      • Ceske Budejovice, Jihočeský, Czechia, 37011
        • MUDr. Alena Vachova
        • Contact:
          • Phone Number: 00420720141003
        • Principal Investigator:
          • Alena Vachova
    • Moravskosl
      • Krnov, Moravskosl, Czechia, 79401
        • MUDr. Tomas Edelsberger
        • Contact:
          • Phone Number: 420606703809
        • Principal Investigator:
          • Tomas Edelsberger
    • Pardubice
      • Pardubice V, Pardubice, Czechia, 530 02
        • Diahelp s.r.o
    • Plzeň-město
      • Pilsen, Plzeň-město, Czechia, 301 00
        • Dialine - Interni a diabetologicka ambulance
        • Contact:
          • Phone Number: 420377732052
        • Principal Investigator:
          • Zdenek Jankovec
    • Praha 1
      • Praha, Praha 1, Czechia, 11000
        • Diabet2 s.r.o., diabetologicka a interni ambulance
        • Contact:
          • Phone Number: 420224810592
        • Principal Investigator:
          • Jakub Hron
    • Praha 4
      • Praha, Praha 4, Czechia, 14900
        • Milan Kvapil s.r.o., Diabetologicka ambulance
        • Contact:
          • Phone Number: 420272917011
        • Principal Investigator:
          • Frantisek Loos
    • Praha 8
      • Praha, Praha 8, Czechia, 18100
        • ResTrial s.r.o.
        • Contact:
          • Phone Number: 420257211886
        • Principal Investigator:
          • Emilia Malicherova
    • Praha-západ
      • Jilove u Prahy, Praha-západ, Czechia, 252 42
        • MUDr. Sabina Palova
        • Contact:
          • Phone Number: 00420774453224
        • Principal Investigator:
          • Sabina Palova
    • Středočeský Kraj
      • Pribram, Středočeský Kraj, Czechia, 26201
        • Milan Kvapil s.r.o., Diabetologicka ambulance Pribram
        • Contact:
          • Phone Number: 420272917011
        • Principal Investigator:
          • Dagmar Bartaskova
  • Germany
      • Gelnhausen, Germany, 63571
        • Diabetes Zentrum Dr. Tews
      • Hamburg, Germany, 21109
        • Diabetes Zentrum Wilhelmsburg
        • Contact:
          • Phone Number: 0049407541703
        • Principal Investigator:
          • Peter Witzel
      • Lübeck, Germany, 23562
        • Universität zu Lübeck - Institut für Endokrinologie und Diabetes
    • Bayern
      • München, Bayern, Germany, 80809
        • CDG Studienambulanz Hartard
        • Principal Investigator:
          • Manfred Hartard
      • Wallerfing, Bayern, Germany, 94574
        • Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf
        • Contact:
          • Phone Number: 004999361315
        • Principal Investigator:
          • Wilma Maria Grosskopf
    • Hessen
      • Pohlheim, Hessen, Germany, 35415
        • Diabetologische Schwerpunktpraxis Marck Linn Pickel
    • Nordrhein-
      • Münster, Nordrhein-, Germany, 48145
        • Institut für Diabetesforschung GmbH Münster
        • Contact:
          • Phone Number: 004925193523
        • Principal Investigator:
          • Ludger Rose
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • InnoDiab Forschung Gmbh
        • Contact:
          • Phone Number: 4920189942100
        • Principal Investigator:
          • Helga Zeller
      • Essen, Nordrhein-Westfalen, Germany, 45355
        • Medizentrum Essen Borbeck
        • Contact:
          • Phone Number: 492018664428
        • Principal Investigator:
          • Axel Schaefer
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • University Hospital of Cologne
    • Sachsen
      • Leipzig, Sachsen, Germany, 04107
        • AmBeNet GmbH
        • Contact:
          • Phone Number: 4934196276326
        • Principal Investigator:
          • Hans-Detlev Stahl
      • Pirna, Sachsen, Germany, 01796
        • Private Practice - Dr. Christine Kosch
    • Sachsen-Anhalt
      • Hohenmölsen, Sachsen-Anhalt, Germany, 06679
        • Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • SMO.MD GmbH
        • Contact:
          • Phone Number: 493916119517
        • Principal Investigator:
          • Heike Schlichthaar
    • Schleswig-Holstein
      • Oldenburg, Schleswig-Holstein, Germany, 23758
        • RED-Institut GmbH
        • Contact:
          • Phone Number: 004943615063012
        • Principal Investigator:
          • Thomas Schaum
  • Greece
      • Larissa, Greece, 41110
        • University General Hospital of Larissa
        • Contact:
          • Phone Number: 00302413502987
        • Principal Investigator:
          • ALEXANDRA BARGIOTA
      • Thessaloniki, Greece, 564 29
        • 424 Military General Training Hospital
    • Attikí
      • Athens, Attikí, Greece, 151 25
        • Athens Medical Center
        • Contact:
          • Phone Number: 302106862530
        • Principal Investigator:
          • Georgia Argyrakopoulou
    • Kentrikí Makedonía
      • Thessaloniki, Kentrikí Makedonía, Greece, 54642
        • Ippokrateio General Hospital of Thessaloniki
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Greece, 570 01
        • Thermi Clinic
        • Contact:
          • Phone Number: 302310024800
        • Principal Investigator:
          • Emmanouil Pagkalos
      • Thessaloniki, Thessaloníki, Greece, 546 45
        • Euromedica General Clinic of Thessaloniki
        • Contact:
          • Phone Number: 00302310895505
        • Principal Investigator:
          • Zadalla Mouslech
      • Thessaloniki, Thessaloníki, Greece, 564 29
        • Papageorgiou General Hospital of Thessaloniki
        • Contact:
          • Phone Number: 0030231332318
        • Principal Investigator:
          • Glykeria Tzatzagou
  • India
    • Chhattisgarh
      • Raipur, Chhattisgarh, India, 492099
        • All India Institute of Medical Sciences
    • Delhi
      • New Delhi, Delhi, India, 110005
        • Dr B. L. Kapur Memorial Hospital
    • Gujarat
      • Anand, Gujarat, India, 388325
        • Shree Krishna Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Medstar Speciality Hospital
        • Contact:
          • Phone Number: 09884457106
        • Principal Investigator:
          • ambrish c
      • Hubli, Karnataka, India, 580021
        • Karnataka Institute of Medical Sciences
        • Principal Investigator:
          • Dr RAM S Kaulgud
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • TOTALL Diabetes Hormone Institute
        • Principal Investigator:
          • Sunil M Jain
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
        • Principal Investigator:
          • Nikhil Madhusudan Bhagwat
      • Mumbai, Maharashtra, India, 400058
        • BSES MG hospital
        • Principal Investigator:
          • MANOJ CHAWLA
      • Nagpur, Maharashtra, India, 441108
        • All India Institute of Medical Sciences (AIIMS) - Nagpur
        • Principal Investigator:
          • Rajashree Sanjay Khot
      • Pune, Maharashtra, India, 411004
        • Sahyadri Super Speciality Hospital
        • Principal Investigator:
          • Uday Phadke
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625020
        • Arthur Asirvatham Hospital
        • Contact:
          • Phone Number: 9443751977
        • Principal Investigator:
          • Arthur Joseph Asirvatham
    • Telangana
      • Hyderabad, Telangana, India, 500072
        • Kumudini Devi Diabetes Research Center
        • Contact:
          • Phone Number: 917842041355
        • Principal Investigator:
          • Vishnupriya Rao Paturi
  • Korea, Republic of
    • Kang-won-do
      • Wonju, Kang-won-do, Korea, Republic of, 26426
        • Yonsei University-Wonju Severance Christian Hospital
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Soo Lim
    • Kyǒngsangbuk-do
      • Gyeongsan-si, Kyǒngsangbuk-do, Korea, Republic of, 42415
        • Yeungnam Univeristy Medical Center
        • Contact:
          • Phone Number: 821093703846
        • Principal Investigator:
          • KYUCHANG WON
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 134-090
        • Kyung Hee University Hospital at Gangdong
        • Contact:
          • Phone Number: 8224406126
        • Principal Investigator:
          • In-Kyung Jeong
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 02841
        • Korea University Anam Hospital
        • Principal Investigator:
          • Sin Gon Kim
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06591
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
  • Puerto Rico
      • Bayamón, Puerto Rico, 00959
        • Advanced Clinical Research, LLC
      • Guaynabo, Puerto Rico, 00969
        • Private Practice - Dr. Paola Mansilla-Letelier
  • United States
    • Alabama
      • Pelham, Alabama, United States, 35124
        • Cahaba Research - Pelham
        • Principal Investigator:
          • Michael Vaughn
        • Contact:
          • Phone Number: 205-408-4134
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Novak Clinical Research - Tucson - North La Cholla Boulevard
        • Principal Investigator:
          • Thili Kulatilake
      • Yuma, Arizona, United States, 85364
        • Yuma Clinical Trials
        • Principal Investigator:
          • Robert Smythe
    • California
      • Escondido, California, United States, 92025
        • AMCR Institute
        • Contact:
          • Phone Number: 760-466-1520
        • Principal Investigator:
          • Timothy S. Bailey
      • Huntington Park, California, United States, 90255
        • National Research Institute - Huntington Park
      • Los Angeles, California, United States, 90057
        • National Research Institute - Wilshire
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
        • Contact:
          • Phone Number: 909-590-8409
        • Principal Investigator:
          • Rizwana H Mohseni
      • Tustin, California, United States, 92780
        • University Clinical Investigators, Inc.
        • Contact:
          • Phone Number: 714-734-7944
        • Principal Investigator:
          • Joanna T. Van
    • Florida
      • Hollywood, Florida, United States, 33021
        • Encore Medical Research
        • Contact:
          • Phone Number: 954-400-1725
        • Principal Investigator:
          • Rodolfo Perez
      • Jacksonville, Florida, United States, 32216
        • East Coast Institute for Research, LLC
        • Contact:
          • Phone Number: 904-854-1354
        • Principal Investigator:
          • Mae Sheikh-Ali
      • Margate, Florida, United States, 33063
        • South Florida Clinical Research Institute
        • Contact:
          • Phone Number: 954-582-7007
        • Principal Investigator:
          • Juan Loy
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Balanced Life Health Care Solutions/SKYCRNG
        • Principal Investigator:
          • Nadia Cameron, MD
        • Contact:
          • Phone Number: 770-996-4541
      • Roswell, Georgia, United States, 30076
        • Endocrine Research Solutions, Inc.
        • Principal Investigator:
          • John Chip H. Reed, III
        • Contact:
          • Phone Number: 6788784750
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
        • Contact:
          • Phone Number: 678-494-5735
        • Principal Investigator:
          • Bram Wieskopf
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Pacific Diabetes & Endocrine Center
        • Contact:
          • Phone Number: 808-526-0303
        • Principal Investigator:
          • ALAN PARSA
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
        • Contact:
          • Phone Number: 208-288-0123
        • Principal Investigator:
          • David J. Butuk
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
        • Contact:
          • Phone Number: 515-329-6800
        • Principal Investigator:
          • Anuj Bhargava
    • Maryland
      • Baltimore, Maryland, United States, 21239
        • MedStar Good Samaritan Hospital
        • Contact:
          • Phone Number: 443-444-6275
        • Principal Investigator:
          • Adline Ghazi
    • Michigan
      • Troy, Michigan, United States, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
        • Contact:
          • Phone Number: 248-312-0025
        • Principal Investigator:
          • Neil J. Fraser
    • Missouri
      • Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
        • Principal Investigator:
          • Timothy R Smith
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research
        • Principal Investigator:
          • Bharat R Mocherla
        • Contact:
          • Phone Number: 702-750-0222
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience Inc.
    • New York
      • Albany, New York, United States, 12203
        • Albany Medical College, Division of Community Endocrinology
        • Contact:
          • Phone Number: 518-264-4420
        • Principal Investigator:
          • Robert Busch
      • Albany, New York, United States, 12208
        • Albany Stratton VA Medical Center
        • Contact:
          • Phone Number: 518-626-5642
        • Principal Investigator:
          • Aidar Gosmanov
      • Long Island City, New York, United States, 11106
        • NYC Research INC
        • Contact:
          • Phone Number: 718-704-5376
        • Principal Investigator:
          • Anastasios Manessis
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Accellacare - Raleigh
        • Contact:
          • Phone Number: 919-783-4895
        • Principal Investigator:
          • John Rubino
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Headlands
        • Contact:
          • Phone Number: 503-972-9805
        • Principal Investigator:
          • James H. Bergthold
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Alliance for Multispecialty Research, LLC
        • Contact:
          • Phone Number: 865-305-9100
        • Principal Investigator:
          • William B. Smith
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Research Center
      • DeSoto, Texas, United States, 75115
        • Epic Medical Research - DeSoto
      • Denison, Texas, United States, 75020
        • Soma Clinical Trials
        • Contact:
          • Phone Number: 469-819-0228
        • Principal Investigator:
          • Hesham Elgouhari
      • San Antonio, Texas, United States, 78230
        • VIP Trials
        • Contact:
          • Phone Number: 2105692672
        • Principal Investigator:
          • Juan Carlos Garza
      • San Antonio, Texas, United States, 78229
        • Diabetes and Glandular Disease Center
        • Contact:
          • Phone Number: 210-615-5594
        • Principal Investigator:
          • Mark S. Kipnes
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research
        • Contact:
          • Phone Number: 434-817-2442
        • Principal Investigator:
          • James R. Clark
    • Washington
      • Tacoma, Washington, United States, 98405
        • Universal Research Group
        • Contact:
          • Phone Number: 2538821070
        • Principal Investigator:
          • Sabrina Ann Benjamin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

  • Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:

    • either diet/exercise alone or
    • up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).

Exclusion Criteria:

  • Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
  • Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
  • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laster photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).
  • Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.
  • Have had a history of chronic or acute pancreatitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo
Drug: Placebo
Administered orally
Experimental: Orforglipron Dose 1
Participants will receive orforglipron administered orally.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Experimental: Orforglipron Dose 2
Participants will receive orforglipron administered orally.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Experimental: Orforglipron Dose 3
Participants will receive orforglipron administered orally.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 72
Baseline, Week 72

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Change from Baseline in Hemoglobin A1c (HbA1c) %
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Change from Baseline in Fasting Glucose
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Percent Change from Baseline in Fasting Insulin
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Change from Baseline in Diastolic Blood Pressure (DBP)
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Change from Baseline in Fasting Triglycerides
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Percent Change from Baseline in Fasting non-High-Density Lipoprotein (HDL) Cholesterol
Time Frame: Baseline, Week 72
Baseline, Week 72
Mean Change from Baseline in Short Form 36 Version 2 Health Survey Acute Form (SF-36v2) Domain Scores
Time Frame: Baseline, Week 72
Baseline, Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18560 (City of Hope Comprehensive Cancer Center)
  • J2A-MC-GZGQ (Other Identifier: Eli Lilly and Company)
  • 2022-502837-24-00 (Other Identifier: Eli Lilly and Company)
  • U1111-1289-8799 (Other Identifier: UTN Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Time Frame:

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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