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Phase 2b Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Maridebart Cafraglutide in Adult Participants Living With Elevated Liver Fat and Obesity or Overweight

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The main objective of this trial will be to determine whether maridebart cafraglutide is superior to placebo on reduction in liver fat content and body weight in participants living with obesity or overweight and elevated liver fat content, when administered in conjunction with reduced-calorie diet and increased physical activity.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Age ≥ 18 years.

• Body Mass index (BMI) ≥ 27 kg/m\^2 to ≤ 40 kg/m\^2 at screening.

• For participants with type 2 diabetes mellitus (T2DM) at screening:

• HbA1c ≤ 9.5% (80 mmol/mol) at screening.

• Treated with diet and exercise alone and/or a stable treatment with metformin, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, or combination.

• Liver Controlled Attenuation Parameter (CAPTM) ≥ 300 dB/meter via FibroScan® assessment.

• Liver fat content ≥ 10% by MRI as determined by the central imaging vendor at screening.

• MRI assessment should only be performed after all other eligibility has been confirmed whenever possible.

• History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

Locations
United States
Arizona
Arizona Clinical Trials
RECRUITING
Chandler
Medical Advancement Centers of Arizona
RECRUITING
Phoenix
California
Apex Clinical Research
RECRUITING
San Diego
Florida
University of Florida College of Medicine-Jacksonville
RECRUITING
Gainesville
Indago Research and Health Center
RECRUITING
Hialeah
Floridian Clinical Research LLC
RECRUITING
Miami Lakes
Maryland
Woodholme Gastroenterology Associates - Glen Burnie
RECRUITING
Glen Burnie
Nevada
Excel Clinical Research
RECRUITING
Las Vegas
Texas
Pinnacle Clinical Research - Corpus Christi
RECRUITING
Corpus Christi
South Texas Research Institute
RECRUITING
Edinburg
Houston Research Institute
RECRUITING
Houston
Houston Research Institute - Pasadena
RECRUITING
Pasadena
McAllen Research
RECRUITING
Pharr
Pinnacle Clinical Research
RECRUITING
San Antonio
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2026-03-05
Estimated Completion Date: 2027-12-22
Participants
Target number of participants: 180
Treatments
Experimental: Maridebart Cafraglutide
Participants will receive maridebart cafraglutide as a subcutaneous (SC) injection every 4 weeks (Q4W) for 52 weeks.
Placebo_comparator: Placebo
Participants will receive placebo as a SC injection Q4W for 52 weeks.
Related Therapeutic Areas
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov