A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight
Recruiting · NCT07441252 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
Maridebart cafraglutidePlacebo
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.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- Recent or planned surgical/device-based obesity treatment (\<1 year).
- History of malignancy within the past 5 years (exceptions apply).
- Type 1 diabetes or non-type 2 diabetes mellitus (T2DM); unstable/severe hypoglycemia.
- Advanced diabetic retinopathy or macular edema.
- History of pancreatitis (acute \<180 days or chronic).
- History of medullary thyroid carcinoma (MTC) or MEN-2
- Major cardiovascular event within 60 days (e.g., myocardial infarction \[MI\], stroke, coronary artery bypass graft \[CABG\]).
- New York Heart Association (NYHA) Class IV heart failure.
- Unstable psychiatric disorders within 2 years.
- Significant liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD) (e.g., hepatitis, cirrhosis, hepatic decompensation).
- Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2 or on dialysis.
- Patient Health Questionnaire-9 (PHQ-9) ≥ 15, or suicidal ideation/behavior (Columbia-Suicide Severity Rating Scale \[C-SSRS\]).
- Inability to undergo MRI scan (e.g., due to metal implant, claustrophobia, or body size limitations).
Where it is running
23 locations listed across 8 US states.
- Arizona Clinical Trials - Chandler, Arizona, United States
- Medical Advancement Centers of Arizona - Phoenix, Arizona, United States
- Del Sol Research Management - Tucson, Arizona, United States
- San Fernando Valley Health Institute - Canoga Park, California, United States
- Gastroenterology and Liver Institute - Escondido, California, United States
- Inland Empire Liver Foundation - Rialto, California, United States
- Apex Clinical Research - San Diego, California, United States
- University of Florida College of Medicine-Jacksonville - Gainesville, Florida, United States
- Floridian Clinical Research LLC - Miami Lakes, Florida, United States
- Indago Research and Health Center - Miami Lakes, Florida, United States
- Gastrointestinal Specialists- Louisiana Research Center- Highland - Shreveport, Louisiana, United States
- Woodholme Gastroenterology Associates - Glen Burnie - Glen Burnie, Maryland, United States
- Alliance for Multispecialty Research - Kansas City - Kansas City, Missouri, United States
- Excel Clinical Research - Las Vegas, Nevada, United States
- Bellaire Clinical Research - Bellaire, Texas, United States
- Juno Research LLC - Bellaire, Texas, United States
- Pinnacle Clinical Research - Corpus Christi - Corpus Christi, Texas, United States
- South Texas Research Institute - Edinburg, Texas, United States
- Houston Research Institute - Houston, Texas, United States
- Houston Research Institute - Pasadena - Pasadena, Texas, United States
- McAllen Research - Pharr, Texas, United States
- American Research Corporation at the Texas Liver Institute - San Antonio, Texas, United States
- Pinnacle Clinical Research - San Antonio, Texas, United States