Overweight or Obesity and Elevated Liver FatPhase 2NCT07441252
A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight
A Phase 2 study testing Maridebart cafraglutide in people with Overweight or Obesity and Elevated Liver Fat, run by Amgen at 23 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Overweight or Obesity and Elevated Liver Fat
- What is being tested?
- Maridebart cafraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 23 sitesUnited States
- Study dates
- 5 Mar 2026to 17 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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).
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Bellaire Clinical Research
Bellaire, Texas, 77401
Juno Research LLC
Bellaire, Texas, 77401
San Fernando Valley Health Institute
Canoga Park, California, 91304
Arizona Clinical Trials
Chandler, Arizona, 85224
Pinnacle Clinical Research - Corpus Christi
Corpus Christi, Texas, 78404
South Texas Research Institute
Edinburg, Texas, 78539
Gastroenterology and Liver Institute
Escondido, California, 92025
University of Florida College of Medicine-Jacksonville
Gainesville, Florida, 32610
Woodholme Gastroenterology Associates - Glen Burnie
Glen Burnie, Maryland, 21061
Houston Research Institute
Houston, Texas, 77079
Alliance for Multispecialty Research - Kansas City
Kansas City, Missouri, 64114
Excel Clinical Research
Las Vegas, Nevada, 89109
Floridian Clinical Research LLC
Miami Lakes, Florida, 33016
Indago Research and Health Center
Miami Lakes, Florida, 33016
Houston Research Institute - Pasadena
Pasadena, Texas, 77505
McAllen Research
Pharr, Texas, 78557
Medical Advancement Centers of Arizona
Phoenix, Arizona, 85044
Inland Empire Liver Foundation
Rialto, California, 92377
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215
Pinnacle Clinical Research
San Antonio, Texas, 78229
Apex Clinical Research
San Diego, California, 92120
Gastrointestinal Specialists- Louisiana Research Center- Highland
Shreveport, Louisiana, 71105
Del Sol Research Management
Tucson, Arizona, 85715
About this study
Official title: 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.
- Being tested
- Maridebart cafraglutide, Placebo
- Keywords
- Obesity, Overweight, Elevated liver fat, AMG 133, Maridebart cafraglutide
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maridebart cafraglutideDrug
Also called AMG 133
Maridebart cafraglutide will be administered as a SC injection.
PlaceboDrug
Placebo will be administered as a SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Maridebart Cafraglutide | Experimental | Participants will receive maridebart cafraglutide as a subcutaneous (SC) injection every 4 weeks (Q4W) for 52 weeks. Receives: Drug: Maridebart cafraglutide |
| Placebo | Placebo comparator | Participants will receive placebo as a SC injection Q4W for 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52
Measured: Baseline and Week 52
Percent Change from Baseline in Body Weight at Week 52
Measured: 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
Measured: Baseline and Week 52
Percent Change from Baseline in Visceral Adipose Tissue (VAT) Volume by MRI at Week 52
Measured: Baseline and Week 52
Number of Participants Achieving < 5% LFC by MRI at Week 52
Measured: Week 52
Change from Baseline in LFC by MRI at Week 52
Measured: Baseline and Week 52
Percent Change from Baseline in LFC by MRI at Week 24
Measured: Baseline and Week 24
Change from Baseline in LFC by MRI at Week 24
Measured: Baseline and Week 24
Percent Change from Baseline in Thigh Muscle Volume by MRI at Week 24 and Week 52
Measured: Baseline, Week 24, and 52
Percent Change from Baseline in Thigh Muscle Fat Fraction by MRI at Week 24 and Week 52
Measured: Baseline, Week 24, and 52
Percent Change from Baseline in Thigh Intermuscular and Intramuscular Fat Volume by MRI at Week 24 and Week 52
Measured: Baseline, Week 24, and 52
Percent Change from Baseline in Abdominal Subcutaneous Adipose Tissue (ASAT) Volume by MRI at Week 52
Measured: Baseline and Week 52
Percent Change from Baseline in VAT Volume by MRI at Week 24
Measured: Baseline and Week 24
Percent Change from Baseline in ASAT Volume by MRI at Week 24
Measured: Baseline and Week 24
Change from Baseline in Waist Circumference at Week 52
Measured: Baseline and Week 52
Change from Baseline in Waist-to-height Ratio at Week 52
Measured: Baseline and Week 52
Change from Baseline in Aspartate Aminotransferase (AST) at Week 52
Measured: Baseline and Week 52
Change from Baseline in Alanine Aminotransferase (ALT) at Week 52
Measured: Baseline and Week 52
Change from Baseline in Gamma Glutamyl Transferase (GGT) at Week 52
Measured: Baseline and Week 52
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 52
Measured: Baseline and Week 52
Change from Baseline in Fasting Glucose at Week 52
Measured: Baseline and Week 52
Percent Change from Baseline in Fasting Insulin at Week 52
Measured: Baseline and Week 52
Plasma Concentration of Maridebart Cafraglutide at Week 52
Measured: Week 52
Number of Participants Experiencing Treatment-emergent adverse events (TEAEs)
Measured: From first dose to end of trial (up to approximately 65 weeks)
Number of Participants Experiencing Serious AEs (SAEs)
Measured: From screening to end of trial (up to approximately 69 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start5 Mar 2026
- Primary completion25 Aug 2027 (estimated)
- Study completion17 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or Obesity and Elevated Liver FatStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441252
- Sponsor's protocol ID
- 20230224
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07441252
- Acronym / sponsor ID
- 20230224
- Keywords
- Obesity, Overweight, Elevated liver fat, AMG 133, Maridebart cafraglutide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 25 Aug 2027 (estimated)
- Study completion
- 17 Nov 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maridebart Cafraglutide | Experimental | Drug: Maridebart cafraglutideParticipants will receive maridebart cafraglutide as a subcutaneous (SC) injection every 4 weeks (Q4W) for 52 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo as a SC injection Q4W for 52 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maridebart cafraglutideAlso: AMG 133Maridebart cafraglutide will be administered as a SC injection. | Drug | Maridebart Cafraglutide |
| PlaceboPlacebo will be administered as a SC injection. | Drug | Placebo |
Primary outcome
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
Percent Change from Baseline in Body Weight at Week 52
Time frame: Baseline and Week 52
23 secondary outcomes
Number of Participants Achieving ≥ 30% Reduction from Baseline in Liver Fat Content (LFC) by MRI at Week 52
Time frame: 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
Number of Participants Achieving < 5% LFC by MRI at Week 52
Time frame: Week 52
Change from Baseline in LFC by MRI at Week 52
Time frame: Baseline and Week 52
Percent Change from Baseline in LFC by MRI at Week 24
Time frame: Baseline and Week 24
Change from Baseline in LFC by MRI at Week 24
Time frame: 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
Percent Change from Baseline in Thigh Muscle Fat Fraction by MRI at Week 24 and Week 52
Time frame: 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
Percent Change from Baseline in Abdominal Subcutaneous Adipose Tissue (ASAT) Volume by MRI at Week 52
Time frame: Baseline and Week 52
Percent Change from Baseline in VAT Volume by MRI at Week 24
Time frame: Baseline and Week 24
Percent Change from Baseline in ASAT Volume by MRI at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Waist Circumference at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Waist-to-height Ratio at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Aspartate Aminotransferase (AST) at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Alanine Aminotransferase (ALT) at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Gamma Glutamyl Transferase (GGT) at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 52
Time frame: Baseline and Week 52
Change from Baseline in Fasting Glucose at Week 52
Time frame: Baseline and Week 52
Percent Change from Baseline in Fasting Insulin at Week 52
Time frame: Baseline and Week 52
Plasma Concentration of Maridebart Cafraglutide at Week 52
Time frame: 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)
Number of Participants Experiencing Serious AEs (SAEs)
Time frame: From screening to end of trial (up to approximately 69 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maridebart cafraglutide in people with Overweight or Obesity and Elevated Liver Fat, run by Amgen at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.