Actively Recruiting
A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight
Led by Amgen · Updated on 2026-05-05
180
Participants Needed
18
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Body mass index (BMI) between 27 and 40 kg/m2 at screening
- For participants with type 2 diabetes: HbA1c 9.5% or less at screening
- Stable treatment with diet and exercise alone and/or metformin, SGLT-2 inhibitors, or combination for diabetes
- Liver Controlled Attenuation Parameter (CAP) 300 dB/meter or higher by FibroScan4 assessment
- Liver fat content 10% or higher by MRI at screening
- History of at least one unsuccessful attempt to lose weight by diet and exercise
You will not qualify if you...
- Surgical or device-based obesity treatment within the past year or planned
- History of cancer within the past 5 years (some exceptions apply)
- Type 1 diabetes or non-type 2 diabetes; unstable or severe low blood sugar
- Advanced diabetic eye disease or macular edema
- History of pancreatitis within the past 180 days or chronic pancreatitis
- History of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Major heart event within 60 days (e.g., heart attack, stroke, coronary artery bypass graft)
- Severe heart failure (New York Heart Association Class IV)
- Unstable psychiatric disorders within the past 2 years
- Significant liver disease other than metabolic dysfunction-associated steatotic liver disease
- Severe kidney disease (eGFR less than 30 mL/min/1.73 m2) or on dialysis
- Patient Health Questionnaire-9 score 15 or higher, or suicidal thoughts or behavior
- Unable to have MRI scan due to metal implant, claustrophobia, or body size limits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Arizona Clinical Trials
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Medical Advancement Centers of Arizona
Phoenix, Arizona, United States, 85044
Actively Recruiting
3
Gastroenterology and Liver Institute
Escondido, California, United States, 92025
Actively Recruiting
4
Inland Empire Liver Foundation
Rialto, California, United States, 92377
Actively Recruiting
5
Apex Clinical Research
San Diego, California, United States, 92120
Actively Recruiting
6
University of Florida College of Medicine-Jacksonville
Gainesville, Florida, United States, 32610
Actively Recruiting
7
Indago Research and Health Center
Hialeah, Florida, United States, 33012
Actively Recruiting
8
Floridian Clinical Research LLC
Miami Lakes, Florida, United States, 33016
Actively Recruiting
9
Woodholme Gastroenterology Associates - Glen Burnie
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
10
Excel Clinical Research
Las Vegas, Nevada, United States, 89109
Actively Recruiting
11
Juno Research LLC
Bellaire, Texas, United States, 77401
Actively Recruiting
12
Pinnacle Clinical Research - Corpus Christi
Corpus Christi, Texas, United States, 78404
Actively Recruiting
13
South Texas Research Institute
Edinburg, Texas, United States, 78539
Actively Recruiting
14
Houston Research Institute
Houston, Texas, United States, 77079
Actively Recruiting
15
Houston Research Institute - Pasadena
Pasadena, Texas, United States, 77505
Actively Recruiting
16
McAllen Research
Pharr, Texas, United States, 78557
Actively Recruiting
17
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
18
Pinnacle Clinical Research
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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