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New drug targets liver fat and weight in obesity trial

NCT ID NCT07441252

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the drug maridebart cafraglutide can reduce liver fat and body weight in adults who are overweight or obese and have high liver fat. Participants will also follow a reduced-calorie diet and increase physical activity. The trial involves 180 adults and lasts about a year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatotic liver disease Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Overweight or obesity and elevated liver fat

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    23 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Alliance for Multispecialty Research - Kansas City

    RECRUITING

    Kansas City, Missouri, 64114, United States

  • American Research Corporation at the Texas Liver Institute

    RECRUITING

    San Antonio, Texas, 78215, United States

  • Apex Clinical Research

    RECRUITING

    San Diego, California, 92120, United States

  • Arizona Clinical Trials

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Bellaire Clinical Research

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Del Sol Research Management

    RECRUITING

    Tucson, Arizona, 85715, United States

  • Excel Clinical Research

    RECRUITING

    Las Vegas, Nevada, 89109, United States

  • Floridian Clinical Research LLC

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Gastroenterology and Liver Institute

    RECRUITING

    Escondido, California, 92025, United States

  • Gastrointestinal Specialists- Louisiana Research Center- Highland

    RECRUITING

    Shreveport, Louisiana, 71105, United States

  • Houston Research Institute

    RECRUITING

    Houston, Texas, 77079, United States

  • Houston Research Institute - Pasadena

    RECRUITING

    Pasadena, Texas, 77505, United States

  • Indago Research and Health Center

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Inland Empire Liver Foundation

    RECRUITING

    Rialto, California, 92377, United States

  • Juno Research LLC

    RECRUITING

    Bellaire, Texas, 77401, United States

  • McAllen Research

    RECRUITING

    Pharr, Texas, 78557, United States

  • Medical Advancement Centers of Arizona

    RECRUITING

    Phoenix, Arizona, 85044, United States

  • Pinnacle Clinical Research

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Pinnacle Clinical Research - Corpus Christi

    RECRUITING

    Corpus Christi, Texas, 78404, United States

  • San Fernando Valley Health Institute

    RECRUITING

    Canoga Park, California, 91304, United States

  • South Texas Research Institute

    RECRUITING

    Edinburg, Texas, 78539, United States

  • University of Florida College of Medicine-Jacksonville

    RECRUITING

    Gainesville, Florida, 32610, United States

  • Woodholme Gastroenterology Associates - Glen Burnie

    RECRUITING

    Glen Burnie, Maryland, 21061, United States

More trials for these conditions

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