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Clinical Trials in the UK / NCT06858839
Active, not recruiting Phase 3

Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

NCT06858839 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 3
Started
2025-03-12
Last updated
2026-09-17

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

Maridebart CafraglutidePlacebo

Maridebart Cafraglutide: Maridebart cafraglutide will be administered SC.

Placebo: Placebo will be administered 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 ≥ 30 kg/m2 or ≥27 kg/m² to \< 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH). * History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. Exclusion Criteria: * Type 1 or Typ2 diabetes mellitus. * Obesity induced by other endocrinologic disorders. * Self-reported change in body weight \> 5 kg within 90 days before screening. * 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 (243)

FacilityCityRegionStatus
Pinnacle Research Group LLC Anniston Alabama
Alliance For Multispecialty Research - Daphne Daphne Alabama
Alliance for Multispecialty Research Mobile Mobile Alabama
Avacare Foothills Research Center Phoenix Arizona
Ark Clinical Research- Tustin Fountain Valley California
Long Beach Clinical Trials Services Inc Long Beach California
Ark Clinical Research- Long Beach Long Beach California
Catalina Research Institute Montclair California
Artemis Institute for Clinical Research Riverside California
Artemis Institute for Clinical Research San Diego California
Apex Clinical Research San Diego California
Southern California Clinical Research Santa Ana California
Diablo Clinical Research Walnut Creek California
Yale School of Medicine New Haven Connecticut
Chase Medical Research LLC Waterbury Connecticut
Indago Research and Health Center Hialeah Florida
Jacksonville Center for Clinical Research Jacksonville Florida
Clinical Neuroscience Solutions - Jacksonville Jacksonville Florida
South Florida Wellness and Clinical Research Institute Margate Florida
Optimus U Corporation Miami Florida
Research Institute of South Florida Miami Florida
Renstar Medical Research Ocala Florida
Clinical Neuroscience Solutions - Orlando Orlando Florida
Combined Research Orlando Phase I IV Orlando Florida
Florida Institute for Clinical Research Orlando Florida
Encore Medical Research of Weston LLC Weston Florida
Center for Advanced Research and Education Gainesville Georgia
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group Union City Georgia
East-West Medical Research Honolulu Hawaii
Solaris Clinical Research Meridian Idaho
Flourish Research - Great Lakes Clinical Trials Chicago Illinois
Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie Skokie Illinois
Evanston Premier Healthcare Research LLC Skokie Illinois
Alliance for Multispecialty Research Newton Newton Kansas
Louisville Metabolic and Atherosclerosis Research Center Louisville Kentucky
Velocity Clinical Research - Baton Rouge Baton Rouge Louisiana
Tandem Clinical Research - Marrero Marrero Louisiana
Headlands Research - Detroit Southfield Michigan
Prime Health and Wellness Sky Clinical Research Network Group Fayette Mississippi
Alliance for Multispecialty Research - Kansas City Kansas City Missouri

+ 203 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 NCT06858839 on ClinicalTrials.gov ↗ ← All trials in the UK