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 atscreening.

• MRI assessment should only be performed after all other eligibility has beenconfirmed whenever possible.

• History of at least 1 self-reported unsuccessful attempt at weight loss by diet andexercise.

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/severehypoglycemia.

• 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 steatoticliver 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 bodysize limitations).