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

June 17, 2026 updated by: Amgen

Phase 2b Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Maridebart Cafraglutide in Adult Participants Living With Elevated Liver Fat and Obesity or Overweight

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Arizona Clinical Trials
      • Phoenix, Arizona, United States, 85044
        • Recruiting
        • Medical Advancement Centers of Arizona
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Del Sol Research Management
    • California
      • Canoga Park, California, United States, 91304
        • Recruiting
        • San Fernando Valley Health Institute
      • Escondido, California, United States, 92025
        • Recruiting
        • Gastroenterology and Liver Institute
      • Rialto, California, United States, 92377
        • Recruiting
        • Inland Empire Liver Foundation
      • San Diego, California, United States, 92120
        • Recruiting
        • Apex Clinical Research
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida College of Medicine-Jacksonville
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Floridian Clinical Research LLC
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Indago Research and Health Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Recruiting
        • Gastrointestinal Specialists- Louisiana Research Center- Highland
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Recruiting
        • Woodholme Gastroenterology Associates - Glen Burnie
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Recruiting
        • Alliance for Multispecialty Research - Kansas City
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • Excel Clinical Research
    • Texas
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Bellaire Clinical Research
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Juno Research LLC
      • Corpus Christi, Texas, United States, 78404
        • Recruiting
        • Pinnacle Clinical Research - Corpus Christi
      • Edinburg, Texas, United States, 78539
        • Recruiting
        • South Texas Research Institute
      • Houston, Texas, United States, 77079
        • Recruiting
        • Houston Research Institute
      • Pasadena, Texas, United States, 77505
        • Recruiting
        • Houston Research Institute - Pasadena
      • Pharr, Texas, United States, 78557
        • Recruiting
        • McAllen Research
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Pinnacle Clinical Research
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • American Research Corporation at the Texas Liver Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Maridebart Cafraglutide
Participants will receive maridebart cafraglutide as a subcutaneous (SC) injection every 4 weeks (Q4W) for 52 weeks.
Drug: Maridebart cafraglutide
Maridebart cafraglutide will be administered as a SC injection.
Other Names:
  • AMG 133
Placebo Comparator: Placebo
Participants will receive placebo as a SC injection Q4W for 52 weeks.
Drug: Placebo
Placebo will be administered as a SC injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants Achieving ≥ 30% Reduction from Baseline in Liver Fat Content (LFC) by MRI at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change from Baseline in Visceral Adipose Tissue (VAT) Volume by MRI at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Number of Participants Achieving < 5% LFC by MRI at Week 52
Time Frame: Week 52
Week 52
Change from Baseline in LFC by MRI at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change from Baseline in LFC by MRI at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Change from Baseline in LFC by MRI at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Percent Change from Baseline in Thigh Muscle Volume by MRI at Week 24 and Week 52
Time Frame: Baseline, Week 24, and 52
Baseline, Week 24, and 52
Percent Change from Baseline in Thigh Muscle Fat Fraction by MRI at Week 24 and Week 52
Time Frame: Baseline, Week 24, and 52
Baseline, Week 24, and 52
Percent Change from Baseline in Thigh Intermuscular and Intramuscular Fat Volume by MRI at Week 24 and Week 52
Time Frame: Baseline, Week 24, and 52
Baseline, Week 24, and 52
Percent Change from Baseline in Abdominal Subcutaneous Adipose Tissue (ASAT) Volume by MRI at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change from Baseline in VAT Volume by MRI at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Percent Change from Baseline in ASAT Volume by MRI at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Change from Baseline in Waist Circumference at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline in Waist-to-height Ratio at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline in Aspartate Aminotransferase (AST) at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline in Alanine Aminotransferase (ALT) at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline in Gamma Glutamyl Transferase (GGT) at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Change from Baseline in Fasting Glucose at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Percent Change from Baseline in Fasting Insulin at Week 52
Time Frame: Baseline and Week 52
Baseline and Week 52
Plasma Concentration of Maridebart Cafraglutide at Week 52
Time Frame: Week 52
Week 52
Number of Participants Experiencing Treatment-emergent adverse events (TEAEs)
Time Frame: From first dose to end of trial (up to approximately 65 weeks)
From first dose to end of trial (up to approximately 65 weeks)
Number of Participants Experiencing Serious AEs (SAEs)
Time Frame: From screening to end of trial (up to approximately 69 weeks)
From screening to end of trial (up to approximately 69 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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