Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
• Intervention / Treatment: Drug: Maridebart cafraglutide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1105
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, 1120
      • Centro Medico Viamonte
    • CABA, Buenos Aires, Argentina, C1407GTN
      • Cemedic Centro de Especialidades Medicas
    • CABA, Buenos Aires, Argentina, C1426ABP
      • Consultorios Medicos Dr Besada
    • CABA, Buenos Aires, Argentina, C1060ABN
      • CEDIC Centro de Investigación Clínica
    • CABA, Buenos Aires, Argentina, C1425AGC
      • Maffei Centro Médico
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1056ABI
      • Cinme - Centro de Investigaciones Metabolicas
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1061AAT
      • Ciprec Centro de Investigacion y Prevencion Cardiovascular
• Bulgaria
  • Pleven, Bulgaria, 5801
    • Ambulatory for specialized outpatient medical aid in endocrinology-Dr Albena Dinkova EOOD
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
  • Sofia, Bulgaria, 1750
    • University Multiprofile Hospital for Active Treatment Sofiamed OOD
  • Sofia, Bulgaria, 1404
    • Diagnostic - Consultative Center XX - Sofia EOOD
  • Stara Zagora, Bulgaria, 6000
    • Prevencia-2000-Medical center for outpatient medical aid OOD
  • Yambol, Bulgaria, 8600
    • Medical Center Berbatov EOOD
• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3T 2V6
      • TLC Diabetes and Endocrinology
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2V 3M3
      • Chronic Disease Innovation Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Nova Scotia Health Authority, Queen Elizabeth ii Health Sciences Centre
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Ltd
    • Brampton, Ontario, Canada, L6S 0C6
      • Centricity Research Brampton
    • Concord, Ontario, Canada, L4K 4M2
      • Centricity Research Vaughan
    • Hamilton, Ontario, Canada, L8J 0B6
      • Winterberry Family Medicine
    • Hamilton, Ontario, Canada, L8L 5G4
      • Premier Clinical Trial Network
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research
    • Nepean, Ontario, Canada, K2J 0V2
      • Centricity Research Ottawa LMC
    • Niagara Falls, Ontario, Canada, L2H 1H5
      • Your Research Network Inc.
    • North York, Ontario, Canada, M6B 3H7
      • North York Diagnostic and Cardiac Centre
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clinical Research Group Incorporated
    • Toronto, Ontario, Canada, M9V 4B4
      • Albion Finch Medical Centre
  • Quebec
    • Lévis, Quebec, Canada, G6W 0M5
      • Centricity Research Quebec City
    • Montreal, Quebec, Canada, H2W 1R7
      • Institut de Recherches Cliniques de Montreal
    • Montreal, Quebec, Canada, H4N 2W2
      • Centre Medical Acadie
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Centricity Research Pointe-Claire
    • Trois-Rivières, Quebec, Canada, G9A 4P3
      • Diex Recherche Trois Rivieres
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni nemocnice Brno
  • Ostrava, Czechia, 702 00
    • CCR Ostrava sro
  • Pardubice, Czechia, 530 02
    • Pratia Pardubice as
  • Pardubice, Czechia, 530 02
    • Diahelp sro
  • Prague, Czechia, 128 08
    • Vseobecna Fakultni Nemocnice V Praze
  • Prague, Czechia, 140 21
    • Institut Klinicke a Experimentalni Mediciny
  • Prague, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Prague, Czechia, 198 00
    • Endokrinologie Cerny Most sro
  • Prague, Czechia, 149 00
    • Milan Kvapil sro
  • Prague, Czechia, 181 00
    • Restrial sro
  • Pribram VIII, Czechia, 261 01
    • Milan Kvapil sro
• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum Aachen
  • Bad Krozingen, Germany, 79189
    • Universitaets-Herzzentrum Freiburg - Bad Krozingen
  • Bad Mergentheim, Germany, 97980
    • Diabetespraxis Bad Mergentheim
  • Bad Oeynhausen, Germany, 32545
    • Universitaetsklinikum der Ruhr-Universitaet Bochum
  • Berlin, Germany, 13597
    • Mvz am Bahnhof Spandau
  • Berlin, Germany, 13187
    • Diabetespraxis Dr. Hermann Braun
  • Berlin, Germany, 10117
    • Charite - Universitaetsmedizin Berlin, Campus Mitte
  • Berlin, Germany, 10787
    • Velocity Clinical Research GmbH
  • Elsterwerda, Germany, 04910
    • Zentrum fuer Klinische Studien Suedbrandenburg GmbH
  • Essen, Germany, 45136
    • InnoDiab Forschung
  • Falkensee, Germany, 14612
    • Schwerpunktpraxis fuer Diabetes, Gefaess- & Ernaehrungsmedizin
  • Hamburg, Germany, 22607
    • Diabeteszentrum Hamburg West
  • Hamburg, Germany, 22767
    • Endokrinologikum Hamburg
  • Hohenmölsen, Germany, 06679
    • Diabetologische Schwerpunktpraxis Hohenmoelsen
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig
  • Leipzig, Germany, 04107
    • AmBeNet GmbH
  • Markkleeberg, Germany, 04416
    • Kardiologische Praxis Doktor Jens Taggeselle
  • München, Germany, 80809
    • Centrum für Diagnostik und Gesundheit
  • Münster, Germany, 48145
    • Zentrum fuer Diabtes und Gefaesskrankheiten im Franziskus Carré Muenster
  • Oldenburg, Germany, 23758
    • RED-Institut GmbH
• Hungary
  • Baja, Hungary, 6500
    • Lausmed Kft
  • Balatonfüred, Hungary, 8230
    • DRC Gyogyszervizsgalo Kozpont Kft
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft
  • Budapest, Hungary, 1033
    • Clinexpert Kft
  • Budapest, Hungary, 1132
    • Med-Tima Kft
  • Budapest, Hungary, 1089
    • ClinDiab Kft
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4025
    • Borvo Clinic Kft
  • Komárom, Hungary, 2900
    • Komaromi Selye Janos Korhaz
  • Nyíregyháza, Hungary, 4405
    • Borbanya Praxis Egeszsegugyi Kft
  • Szombathely, Hungary, 9700
    • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
  • Chieti, Italy, 66100
    • Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
  • Florence, Italy, 50134
    • Azienda Ospedaliero Universitaria Careggi
  • Milan, Italy, 20122
    • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  • Milan, Italy, 20138
    • IRCCS Centro Cardiologico Monzino
  • Milan, Italy, 20157
    • Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco
  • Palermo, Italy, 90127
    • Ospedale Civico, Di Cristina e Benfratelli
• Japan
  • Ehime
    • Matsuyama, Ehime, Japan, 790-0034
      • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
  • Fukuoka
    • Kitakyusyu-shi, Fukuoka, Japan, 807-0072
      • Morizono Medical Clinic
  • Hiroshima
    • Aki-gun, Hiroshima, Japan, 735-8585
      • Mazda Hospital of Mazda Motor Corporation
  • Ibaraki
    • Mito, Ibaraki, Japan, 310-0826
      • Nakamoto Medical Clinic
    • Naka, Ibaraki, Japan, 311-0113
      • Nakakinen clinic
    • Tsuchiura-shi, Ibaraki, Japan, 300-0835
      • Ohishi Naika Clinic
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 860-0863
      • Morinaga Ueno Clinic
  • Osaka
    • Kashiwara-shi, Osaka, Japan, 582-0005
      • Shiraiwa Medical Clinic
  • Shizuoka
    • Shizuoka, Shizuoka, Japan, 424-0855
      • Suruga Clinic
  • Tokyo
    • Meguro-ku, Tokyo, Japan, 153-0053
      • Yutenji Medical Clinic
    • Mitaka-shi, Tokyo, Japan, 181-0013
      • Medical Corporation Ouitsukai Kanno Naika
• Poland
  • Katowice, Poland, 40-772
    • Salvia-Lekston i Madej Spolka Jawna
  • Lodz, Poland, 90-338
    • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
  • Lublin, Poland, 20-718
    • Ekamed Spolka z Ograniczona Odpowiedzialnoscia
  • Lublin, Poland, 20-011
    • Clinical Best Solutions Sp zoo Spolka Komandytowa Gabinet Lekarski
  • Oświęcim, Poland, 32-600
    • Medicome Spolka z Ograniczona Odpowiedzialnoscia
  • Puławy, Poland, 24-100
    • Velocity Nova Sp zoo Velocity Pulawy
  • Ruda Śląska, Poland, 41-709
    • NZOZ Przychodnia Specjalistyczna A Wittek H Rudzki spolka jawna
  • Staszów, Poland, 28-200
    • Velocity Nova Sp zoo Velocity Staszow
  • Warsaw, Poland, 02-507
    • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
  • Warsaw, Poland, 00-710
    • NBR Polska Tomasz Klodawski
  • Wroclaw, Poland, 51-685
    • Wromedica I Bielicka A Strzalkowska SC
  • Świdnik, Poland, 21-040
    • Tomasz Blicharski Lubelskie Centrum Diagnostyczne
• Puerto Rico
  • San Juan, Puerto Rico, 00909
    • Latin Clinical Trial Center
• South Korea
  • Ansan-si, Gyeonggi-do, South Korea, 15355
    • Korea University Ansan Hospital
  • Daegu, South Korea, 42415
    • Yeungnam University Medical Center
  • Seongnam-si, Gyeonggi-do, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Marys Hospital
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
  • Seoul, South Korea, 07441
    • Hallym University Kangnam Sacred Heart Hospital
  • Seoul, South Korea, 05278
    • KyungHee University Gangdong Hospital
  • Wonju-si, Gangwon-do, South Korea, 26426
    • Yonsei University Wonju Severance Christian Hospital
• United Kingdom
  • Belfast, United Kingdom, BT28BG
    • Ormeau Clinical Trials Ltd
  • Birmingham, United Kingdom, B21 9RY
    • FutureMeds Birmingham
  • Blackpool, United Kingdom, FY4 3AD
    • Waterloo Medical Centre
  • Blackpool, United Kingdom, FY3 7EN
    • Layton Medical Centre
  • Bristol, United Kingdom, BS10 5NB
    • Southmead Hospital
  • Ely, United Kingdom, CB7 5JD
    • Staploe Medical Centre
  • Glasgow, United Kingdom, G20 7BE
    • FutureMeds Glasgow
  • Hull, United Kingdom, HU3 2JZ
    • Hull Royal Infirmary
  • Leicester, United Kingdom, LE5 4PW
    • NIHR Leicestershire & Northamptonshire Commercial Research Delivery Centre
  • Liverpool, United Kingdom, L9 7AL
    • Aintree University Hospital
  • Rotherham, United Kingdom, S65 1DA
    • Clifton Medical Centre
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Alliance for Multispecialty Research Mobile
  • Arizona
    • Gilbert, Arizona, United States, 85296
      • Gilbert Center for Family Medicine
    • Mesa, Arizona, United States, 85213
      • Desert Clinical Research
    • Phoenix, Arizona, United States, 85044
      • Avacare Foothills Research Center
  • California
    • Canoga Park, California, United States, 91304
      • San Fernando Valley Health Institute
    • Cerritos, California, United States, 90703
      • Core Healthcare Group
    • Chula Vista, California, United States, 91911
      • Velocity Clinical Research Chula Vista
    • Escondido, California, United States, 92025
      • Headlands Research California
    • Modesto, California, United States, 95355
      • Paradigm Clinical Research
    • Northridge, California, United States, 91325
      • Flourish Research
    • Orange, California, United States, 92868
      • University of California Irvine
    • Pomona, California, United States, 91767
      • Empire Clinical Research
    • San Diego, California, United States, 92108
      • Infinity Clinical Trials
  • Connecticut
    • Riverside, Connecticut, United States, 06878
      • Greenwich Clinical Trials
  • Florida
    • Hialeah, Florida, United States, 33012
      • Indago Research and Health Center
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Miami, Florida, United States, 33135
      • Optimus U Corporation
    • Miami Lakes, Florida, United States, 33014
      • San Marcus Research Clinic Inc
    • Orlando, Florida, United States, 32825
      • Florida Institute for Clinical Research
    • Weston, Florida, United States, 33331
      • Encore Medical Research of Weston LLC
    • Winter Park, Florida, United States, 32789
      • Conquest Research - Winter Park
  • Illinois
    • Oak Brook, Illinois, United States, 60523
      • Alliance For Multispecialty Research - Oak Brook
    • Park Ridge, Illinois, United States, 66068
      • Alliance for Multispecialty Research, LLC - Park Ridge
    • Skokie, Illinois, United States, 60077
      • Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie
  • Indiana
    • Merrillville, Indiana, United States, 46410
      • Indiana Medical Research Institute
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Diabetes Research
  • Kansas
    • Newton, Kansas, United States, 67114
      • Alliance for Multispecialty Research Newton
    • Wichita, Kansas, United States, 67207
      • Alliance for Multispecialty Research LLC
  • Kentucky
    • Paducah, Kentucky, United States, 42001
      • Advanced Internal Medicine
  • Louisiana
    • Monroe, Louisiana, United States, 71201
      • Ima Clinical Research- Monroe
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Annapolis Internal Medicine, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Womens Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • International Diabetes Center - HealthPartners Institute
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Alliance for Multispecialty Research - Kansas City
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Palm Research Center Inc
    • Sparks, Nevada, United States, 89436
      • Vector Clinical Trials
  • New Jersey
    • Trenton, New Jersey, United States, 08611
      • Premier Research
  • New York
    • Albany, New York, United States, 12203
      • Albany Medical College
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Clinical Research
    • Greenville, North Carolina, United States, 27834
      • Physicians East
    • Morehead City, North Carolina, United States, 28557
      • Carteret Medical Group
    • Morehead City, North Carolina, United States, 28557
      • West Clinical Research
  • Ohio
    • Blue Ash, Ohio, United States, 45242
      • Velocity Clinical Research - Cincinnati
    • Cincinnati, Ohio, United States, 45246
      • Velocity Clinical Research - Springdale
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research - Providence
  • Tennessee
    • Elizabethton, Tennessee, United States, 37643
      • Medical Care LLC
  • Texas
    • Austin, Texas, United States, 78701
      • Elligo Clinical Research Center
    • Corpus Christi, Texas, United States, 78414
      • Osvaldo A Brusco MD PA
    • Dallas, Texas, United States, 75251
      • Cedar Health Research, LLC
    • Denison, Texas, United States, 75020
      • Soma Clinical Trials, LLC
    • Euless, Texas, United States, 76040
      • Cedar Health Research, LLC
    • Houston, Texas, United States, 77054
      • Juno Research LLC
    • Houston, Texas, United States, 77040
      • Juno Research LLC
    • McKinney, Texas, United States, 75069
      • Tekton Research
    • San Antonio, Texas, United States, 78233
      • Northeast Clinical Research of San Antonio LLC
  • Utah
    • Layton, Utah, United States, 84041
      • Alliance for Multispecialty Research - Layton
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center Inc
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Healthcare System
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Ima Clinical Research - West Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years.
• Body mass index ≥ 27 kg/m^2.
• History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
• Diagnosis of T2DM.

Exclusion Criteria:

• Type 1 diabetes mellitus.
• Self-reported change in body weight > 5 kg within 90 days before screening.
• Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
• Obesity induced by other endocrinologic disorders.
• Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
• History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
• History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
• Lifetime history of suicide attempt.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maridebart Cafraglutide High Dose; Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.	Drug: Maridebart cafraglutide; Maridebart cafraglutide will be adminstered SC.; Other Names: AMG 133; MariTide
Experimental: Maridebart Cafraglutide Medium Dose; Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.	Drug: Maridebart cafraglutide; Maridebart cafraglutide will be adminstered SC.; Other Names: AMG 133; MariTide
Experimental: Maridebart Cafraglutide Low Dose; Participants will receive maridebart cafraglutide low dose SC for 72 weeks.	Drug: Maridebart cafraglutide; Maridebart cafraglutide will be adminstered SC.; Other Names: AMG 133; MariTide
Placebo Comparator: Placebo; Participants will receive placebo SC for 72 weeks.	Drug: Placebo; Placebo will be adminstered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change from Baseline in Body Weight at Week 72	Baseline and Week 72

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Waist Circumference at Week 72	Baseline and Week 72
Change from Baseline in Systolic Blood Pressure (SBP) at Week 72	Baseline and Week 72
Percent Change from Baseline in Fasting Triglycerides at Week 72	Baseline and Week 72
Change from Baseline in Fasting Plasma Glucose at Week 72	Baseline and Week 72
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72	Baseline and Week 72
Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72	Baseline and Week 72
Change from Baseline in Body Weight at Week 72	Baseline and Week 72
Change from Baseline in Body Mass Index (BMI) at Week 72	Baseline and Week 72
Percent Change from Baseline in Fasting Insulin at Week 72	Baseline and Week 72
Percent Change from Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72	Baseline and Week 72
Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72	Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol	Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of Non-high-density Lipoprotein Cholesterol (non-HDL-C)	Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of Low-density Lipoprotein Cholesterol (LDL-C)	Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C)	Baseline and Week 72
Percent Change from Baseline at Week 72 in Fasting Concentration of High-density Lipoprotein Cholesterol (HDL-C)	Baseline and Week 72
Change from Baseline in Diastolic Blood Pressure DBP at Week 72	Baseline and Week 72
Change from Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72	Baseline and Week 72
Number of Participants who Experienced Treatment-emergent Adverse Events	Up to Week 84
Number of Participants who Experienced Serious Adverse Events	Up to Week 84
Plasma Concentration of Maridebart Cafraglutide at Week 72	Week 72
Participant achieving ≥ 5% reduction in body weight from baseline at week 72	Baseline and Week 72
Participant achieving ≥ 10% reduction in body weight from baseline at week 72	Baseline and Week 72
Participant achieving ≥ 15% reduction in body weight from baseline at week 72	Baseline and Week 72
Participant achieving HbA1c < 7% at week 72	Week 72
Participant achieving ≥ 20% reduction in body weight from baseline at week 72	Baseline and Week 72
Participant achieving HbA1c ≤ 6.5% at week 72	Week 72
Participant achieving HbA1c < 5.7%, at week 72	Week 72

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): January 21, 2027
• Study Completion (Estimated): April 16, 2027

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Overweight; T2DM; Type 2 Diabetes Mellitus; AMG 133; Maridebart Cafraglutide; MariTide; Chronic Weight Management
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 20210184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; 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