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

Amgen

Status and phase: Enrolling; Phase 2

Conditions: Overweight or Obesity and Elevated Liver Fat

Treatments: Drug: Placebo; Drug: Maridebart cafraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07441252

20230224

Details and patient eligibility

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

180 participants in 2 patient groups, including a placebo group

Maridebart Cafraglutide

Experimental group

Description:

Participants will receive maridebart cafraglutide as a subcutaneous (SC) injection every 4 weeks (Q4W) for 52 weeks.

Treatment:

Drug: Maridebart cafraglutide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo as a SC injection Q4W for 52 weeks.

Treatment:

Drug: Placebo