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Study identifier: NCT07441252 Synced from ClinicalTrials.gov · August 09, 2026
● Study status: Recruiting

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

Condition: Overweight or Obesity and Elevated Liver Fat  ·  Sponsor: Amgen

PhasePhase 2
Planned participants180
Who can joinAll sexes, 18 Years to 99 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where23 locations

Interested? Contact the study team ↓

For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Amgen Call Center  ·  866-572-6436  ·  medinfo@amgen.com

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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).

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (23)

Arizona Clinical TrialsChandler, Arizona, United StatesRecruiting
Medical Advancement Centers of ArizonaPhoenix, Arizona, United StatesRecruiting
Del Sol Research ManagementTucson, Arizona, United StatesRecruiting
San Fernando Valley Health InstituteCanoga Park, California, United StatesRecruiting
Gastroenterology and Liver InstituteEscondido, California, United StatesRecruiting
Inland Empire Liver FoundationRialto, California, United StatesRecruiting
Apex Clinical ResearchSan Diego, California, United StatesRecruiting
University of Florida College of Medicine-JacksonvilleGainesville, Florida, United StatesRecruiting
Floridian Clinical Research LLCMiami Lakes, Florida, United StatesRecruiting
Indago Research and Health CenterMiami Lakes, Florida, United StatesRecruiting
Gastrointestinal Specialists- Louisiana Research Center- HighlandShreveport, Louisiana, United StatesRecruiting
Woodholme Gastroenterology Associates - Glen BurnieGlen Burnie, Maryland, United StatesRecruiting

+ 11 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

ChandlerPhoenixTucsonCanoga Park

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