A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAmgen
About this trial
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 criteria
Qualifiers
Age ≥ 18 years.
Body Mass index (BMI) ≥ 27 kg/m² to ≤ 40 kg/m² 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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Maridebart cafraglutide
- Placebo
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov