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Tests treatment safety and results for Overweight or Obesity and Elevated Liver Fat
Official title A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight
ClinicalTrials.gov ID: NCT07441252
What this study is testing
What is Maridebart cafraglutide?
Maridebart cafraglutide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for overweight or obesity and elevated liver fat.
Also referred to as AMG 133.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join 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.
You likely can't join 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
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Canoga Park, California, United States
- Escondido, California, United States
- Rialto, California, United States
- San Diego, California, United States
- Gainesville, Florida, United States
- Miami Lakes, Florida, United States
- Shreveport, Louisiana, United States
- Glen Burnie, Maryland, United States
- Kansas City, Missouri, United States
- Las Vegas, Nevada, United States
- Bellaire, Texas, United States
- Corpus Christi, Texas, United States
- Edinburg, Texas, United States
- Houston, Texas, United States
- Pasadena, Texas, United States
- Pharr, Texas, United States
- San Antonio, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Canoga Park, California, United States; Escondido, California, United States; Rialto, California, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.