A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight

Conditions

• Overweight or Obesity and Elevated Liver Fat

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Maridebart cafraglutide — DRUG
  Maridebart cafraglutide will be administered as a SC injection.
• Placebo — DRUG
  Placebo will be administered as a SC injection.

Study Details

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.

Key Dates

Start date

Mar 5, 2026

Status verified

Jun 2026

Primary completion

Sep 29, 2027

Completion

Dec 22, 2027

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52 [ Time Frame: Baseline and Week 52 ]

Central Contacts

• Amgen Call Center
  866-572-6436
  [email protected]

Locations (22)

Find similar trials in Chandler, AZ