Overweight or Obesity and Elevated Li...

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

About this trial

Last updated a month ago

Study ID

20230224

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18 to 99 Years

All Sexes

Trial Timing

Started 2 months ago

What is this trial 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.

What are the participation requirements?

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).