> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-maridebart-cafraglutide-in-adult-participants-a4b4a7f3-685e-4968-8c22-ce0ed4ba6024 > Record changed: 2026-10-13 # A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM) NCT06660173 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) Participants 409 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) Start date 2024-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) Number of sites 96 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) ## Title and summary **Summary** The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Short title** A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Official title** A Study to Evaluate the Efficacy, Safety & Tolerability of Maridebart Cafraglutide in Adults With T2DM Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) ## Dates **Completion date** 2026-11-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **First posted** 2024-10-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Registry last updated** 2025-11-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Primary completion date** 2025-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Start date** 2024-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) ## Size and sites **Actual participants** 409 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Participants** 409 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Number of sites** 96 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) ## Identifiers **Registry ID** NCT06660173 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **ClinicalTrials.gov ID** NCT06660173 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) ## Outcomes ### Primary outcomes 1. Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) Timeframe: Baseline to Week 24 ### Secondary outcomes 1. Percent Change From Baseline to Week 24 in Body Weight Timeframe: Baseline to Week 24 2. Number of Participants Achieving HbA1c < 7.0% at Week 24 Timeframe: Week 24 3. Number of Participants Achieving HbA1c ≤ 6.5% at Week 24 Timeframe: Week 24 4. Number of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 24 Timeframe: Week 24 5. Number of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 24 Timeframe: Week 24 6. Change From Baseline to Week 24 in Fasting Glucose Timeframe: Baseline to Week 24 7. Percent Change From Baseline to Week 24 in Total Cholesterol Timeframe: Baseline to Week 24 8. Percent Change From Baseline to Week 24 in Low-density Lipoprotein Cholesterol (LDL-C) Timeframe: Baseline to Week 24 9. Percent Change From Baseline to Week 24 in High-density Lipoprotein Cholesterol (HDL-C) Timeframe: Baseline to Week 24 10. Percent Change From Baseline to Week 24 in Non-high Density Lipoprotein Cholesterol (non-HDL-C) Timeframe: Baseline to Week 24 11. Percent Change From Baseline to Week 24 in Very-low-density Lipoprotein Cholesterol (VLDL-C) Timeframe: Baseline to Week 24 12. Percent Change From Baseline to Week 24 in Triglycerides Timeframe: Baseline to Week 24 13. Percent Change From Baseline to Week 24 in Free Fatty Acids (FFA) Timeframe: Baseline and Week 24 14. Change From Baseline to Week 24 in Systolic Blood Pressure Timeframe: Baseline and Week 24 15. Change From Baseline to Week 24 in Diastolic Blood Pressure Timeframe: Baseline and Week 24 16. Change from Baseline to Week 24 in High-sensitivity C-reactive Protein Timeframe: Baseline and Week 24 17. Pre-dose Plasma Concentration of Maridebart Cafraglutide at Week 20 Timeframe: Week 20 18. Maximum Observed Plasma Concentration of Maridebart Cafraglutide at Week 20 Timeframe: Week 20 19. Number of Participants with Treatment Emergent Adverse Events Timeframe: Up to 24 Weeks 20. Number of Participants with Serious Adverse Events Timeframe: Up to 24 Weeks 21. Number of Participants with Anti-maridebart Cafraglutide Antibody Formation Timeframe: Up to Week 24 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years) - Type 2 diabetes for ≥6 months according to the World Health Organization classification - HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory - Treatment of diabetes with diet and exercise alone, or with a stable dose of metformin, with or without a sodium-glucose cotransporter-2 inhibitor, for at least 3 months prior to screening - Body mass index of 23 to 50 kilograms per square meter ### Exclusion criteria - Type 1 diabetes - Use of any glucose-lowering medication, other than metformin with or without a sodium-glucose cotransporter-2 inhibitor, within 3 months prior to screening - Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology equation. - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy - History of acute or chronic pancreatitis - Malignancy within 5 years before screening, except for nonmelanoma skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer - Myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention, transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure within 90 days prior to screening, or currently have New York Heart Association Class III or IV heart failure. - Use of medications that affect glucose control or body weight or history of bariatric surgery or procedures. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) ## Sites - Accel Research Site - Birmingham Clinical Research UnitBirmingham, United States - Anaheim Clinical TrialsAnaheim, United States - Hope Clinical Research LLCCanoga Park, United States - Orange County Research CenterLake Forest, United States - San Jose Clinical TrialsSan Jose, United States - Northeast Research Institute - NeriFleming Island, United States - New Horizon Research CenterMiami, United States - Florida Institute for Clinical ResearchOrlando, United States - Conquest Research - Winter ParkWinter Park, United States - Accel Research Site - NeurostudiesDecatur, United States - Cedar Crosse Research and Health CareChicago, United States - Tandem Clinical Research - MarreroMarrero, United States - DM Clinical - DetroitSouthfield, United States - Montana Medical ResearchMissoula, United States - Physicians EastGreenville, United States - Diabetes and Endocrinology Associates of Stark County IncCanton, United States - Alliance for Multispecialty ResearchNorman, United States - Trial Management Associates - Myrtle BeachMyrtle Beach, United States - FutureSearch Trials of NeurologyAustin, United States - Velocity Clinical Research - DallasDallas, United States - DM Clinical Research - Cyfair Clinical Research CenterHouston, United States - Southern Endocrinology Associates PAMesquite, United States - Be Well Clinical StudiesRound Rock, United States - Diabetes and Glandular Disease ClinicSan Antonio, United States - DM Clinical Research - Martin Diagnostic ClinicTomball, United States And 71 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) ## References - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) ### Other registry identifiers - 2024-513539-25-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06660173) ## Related records ### Drugs (1) - [Maridebart cafraglutide](https://trialight.com/data/asset/maridebart-cafraglutide-ed4d163f-9dd6-42fa-9ba3-bc4358617867.md) ### Lead sponsors (1) - [Amgen](https://trialight.com/data/company/amgen-e0106b98-aeaf-49cc-b95a-04f4be619a07.md) ### Conditions (2) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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