Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
180 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for
This trial is looking for adults with obesity or overweight and high liver fat. Participants will take maridebart cafraglutide while following a low-calorie diet and increasing physical activity to see if it helps reduce liver fat and weight.
I have tried to lose weight before without success.
I have high liver fat content confirmed by an MRI.
I have type 2 diabetes and my blood sugar levels are controlled.
You may not be able to join if
I have had major heart issues in the last 60 days.
I have had pancreatitis.
I have unstable psychiatric conditions.
I have a history of certain cancers in the last 5 years.
I cannot have an MRI scan.
I have advanced eye problems due to diabetes.
I have significant liver disease that isn't related to my weight.
I have type 1 diabetes.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
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, …
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).
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