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Clinical Trials in the UK / NCT06858878
Active, not recruiting Phase 3

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

NCT06858878 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 3
Started
2025-03-17
Last updated
2025-12-31

Condition(s) studied

Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Investigational drug(s) / intervention(s)

Maridebart cafraglutidePlacebo

Maridebart cafraglutide: Maridebart cafraglutide will be adminstered SC.

Placebo: Placebo will be adminstered SC.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (187)

FacilityCityRegionStatus
Alliance for Multispecialty Research Mobile Mobile Alabama
Gilbert Center for Family Medicine Gilbert Arizona
Desert Clinical Research Mesa Arizona
Avacare Foothills Research Center Phoenix Arizona
San Fernando Valley Health Institute Canoga Park California
Core Healthcare Group Cerritos California
Velocity Clinical Research Chula Vista Chula Vista California
Headlands Research California Escondido California
Paradigm Clinical Research Modesto California
Flourish Research Northridge California
University of California Irvine Orange California
Empire Clinical Research Pomona California
Infinity Clinical Trials San Diego California
Greenwich Clinical Trials Riverside Connecticut
Indago Research and Health Center Hialeah Florida
Optimus U Corporation Miami Florida
New Horizon Research Center Miami Florida
San Marcus Research Clinic Inc Miami Lakes Florida
Florida Institute for Clinical Research Orlando Florida
Encore Medical Research of Weston LLC Weston Florida
Conquest Research - Winter Park Winter Park Florida
Alliance For Multispecialty Research - Oak Brook Oak Brook Illinois
Alliance for Multispecialty Research, LLC - Park Ridge Park Ridge Illinois
Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie Skokie Illinois
Indiana Medical Research Institute Merrillville Indiana
Iowa Diabetes Research West Des Moines Iowa
Alliance for Multispecialty Research Newton Newton Kansas
Alliance for Multispecialty Research LLC Wichita Kansas
Advanced Internal Medicine Paducah Kentucky
Ima Clinical Research- Monroe Monroe Louisiana
Annapolis Internal Medicine, LLC Annapolis Maryland
Brigham and Womens Hospital Boston Massachusetts
International Diabetes Center - HealthPartners Institute Minneapolis Minnesota
Alliance for Multispecialty Research - Kansas City Kansas City Missouri
Palm Research Center Inc Las Vegas Nevada
Vector Clinical Trials Sparks Nevada
Premier Research Trenton New Jersey
Albany Medical College Albany New York
Asheville Clinical Research Asheville North Carolina
Physicians East Greenville North Carolina

+ 147 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06858878 on ClinicalTrials.gov ↗ ← All trials in the UK