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

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).