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

NCT07441252 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20230224
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 23

Brief Summary

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.

Conditions

Overweight or Obesity and Elevated Liver Fat

Keywords

Obesity; Overweight; Elevated liver fat; AMG 133; Maridebart cafraglutide

Outcome Measures

Primary Outcomes (2)

• Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52

  Baseline and Week 52

• Percent Change from Baseline in Body Weight at Week 52

  Baseline and Week 52

Secondary Outcomes (23)

• Number of Participants Achieving ≥ 30% Reduction from Baseline in Liver Fat Content (LFC) by MRI at Week 52

  Baseline and Week 52

• Percent Change from Baseline in Visceral Adipose Tissue (VAT) Volume by MRI at Week 52

  Baseline and Week 52

• Number of Participants Achieving < 5% LFC by MRI at Week 52

  Week 52

• Change from Baseline in LFC by MRI at Week 52

  Baseline and Week 52

• Percent Change from Baseline in LFC by MRI at Week 24

  Baseline and Week 24

Study Arms (2)

Maridebart Cafraglutide

EXPERIMENTAL

Participants will receive maridebart cafraglutide as a subcutaneous (SC) injection every 4 weeks (Q4W) for 52 weeks.

Drug: Maridebart cafraglutide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo as a SC injection Q4W for 52 weeks.

Drug: Placebo

Interventions

Maridebart cafraglutide DRUG

Maridebart cafraglutide will be administered as a SC injection.

Also known as: AMG 133

Maridebart Cafraglutide

Placebo DRUG

Placebo will be administered as a SC injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Amgen: lead

Study Sites (23)

Arizona Clinical Trials

Chandler, Arizona, 85224, United States

RECRUITING

Medical Advancement Centers of Arizona

Phoenix, Arizona, 85044, United States

RECRUITING

Del Sol Research Management

Tucson, Arizona, 85715, United States

RECRUITING

San Fernando Valley Health Institute

Canoga Park, California, 91304, United States

RECRUITING

Gastroenterology and Liver Institute

Escondido, California, 92025, United States

RECRUITING

Inland Empire Liver Foundation

Rialto, California, 92377, United States

RECRUITING

Apex Clinical Research

San Diego, California, 92120, United States

RECRUITING

University of Florida College of Medicine-Jacksonville

Gainesville, Florida, 32610, United States

RECRUITING

Floridian Clinical Research LLC

Miami Lakes, Florida, 33016, United States

RECRUITING

Indago Research and Health Center

Miami Lakes, Florida, 33016, United States

RECRUITING

Gastrointestinal Specialists- Louisiana Research Center- Highland

Shreveport, Louisiana, 71105, United States

RECRUITING

Woodholme Gastroenterology Associates - Glen Burnie

Glen Burnie, Maryland, 21061, United States

RECRUITING

Alliance for Multispecialty Research - Kansas City

Kansas City, Missouri, 64114, United States

RECRUITING

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

RECRUITING

Bellaire Clinical Research

Bellaire, Texas, 77401, United States

RECRUITING

Juno Research LLC

Bellaire, Texas, 77401, United States

RECRUITING

Pinnacle Clinical Research - Corpus Christi

Corpus Christi, Texas, 78404, United States

RECRUITING

South Texas Research Institute

Edinburg, Texas, 78539, United States

RECRUITING

Houston Research Institute

Houston, Texas, 77079, United States

RECRUITING

Houston Research Institute - Pasadena

Pasadena, Texas, 77505, United States

RECRUITING

McAllen Research

Pharr, Texas, 78557, United States

RECRUITING

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, 78215, United States

RECRUITING

Pinnacle Clinical Research

San Antonio, Texas, 78229, United States

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 27, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): September 29, 2027
• Study Completion (Estimated): December 22, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (23)