> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-maridebart-cafraglutide-in-adult-ec2bf21b-f077-41a7-994f-e832c5420f1b > Record changed: 2026-10-13 # Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight NCT06858878 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) Participants 1,105 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) Start date 2025-03-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) Number of sites 187 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) ## Title and summary **Summary** The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Acronym** MARITIME-2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Short title** Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Official title** A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) ## Dates **Completion date** 2027-04-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **First posted** 2025-03-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Registry last updated** 2025-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Primary completion date** 2027-01-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Start date** 2025-03-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) ## Size and sites **Actual participants** 1,105 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Participants** 1,105 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Number of sites** 187 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) ## Identifiers **Registry ID** NCT06858878 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **ClinicalTrials.gov ID** NCT06858878 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) ## 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/NCT06858878) ## Outcomes ### Primary outcomes 1. Percent Change from Baseline in Body Weight at Week 72 Timeframe: Baseline and Week 72 ### Secondary outcomes 1. Change from Baseline in Waist Circumference at Week 72 Timeframe: Baseline and Week 72 2. Participant achieving ≥ 5% reduction in body weight from baseline at week 72 Timeframe: Baseline and Week 72 3. Participant achieving ≥ 10% reduction in body weight from baseline at week 72 Timeframe: Baseline and Week 72 4. Participant achieving ≥ 15% reduction in body weight from baseline at week 72 Timeframe: Baseline and Week 72 5. Change from Baseline in Systolic Blood Pressure (SBP) at Week 72 Timeframe: Baseline and Week 72 6. Percent Change from Baseline in Fasting Triglycerides at Week 72 Timeframe: Baseline and Week 72 7. Change from Baseline in Fasting Plasma Glucose at Week 72 Timeframe: Baseline and Week 72 8. Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72 Timeframe: Baseline and Week 72 9. Participant achieving HbA1c < 7% at week 72 Timeframe: Week 72 10. Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72 Timeframe: Baseline and Week 72 11. Change from Baseline in Body Weight at Week 72 Timeframe: Baseline and Week 72 12. Participant achieving ≥ 20% reduction in body weight from baseline at week 72 Timeframe: Baseline and Week 72 13. Change from Baseline in Body Mass Index (BMI) at Week 72 Timeframe: Baseline and Week 72 14. Participant achieving HbA1c ≤ 6.5% at week 72 Timeframe: Week 72 15. Participant achieving HbA1c < 5.7%, at week 72 Timeframe: Week 72 16. Percent Change from Baseline in Fasting Insulin at Week 72 Timeframe: Baseline and Week 72 17. Percent Change from Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72 Timeframe: Baseline and Week 72 18. Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72 Timeframe: Baseline and Week 72 19. Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol Timeframe: Baseline and Week 72 20. Percent Change from Baseline at Week 72 in Fasting Concentration of Non-high-density Lipoprotein Cholesterol (non-HDL-C) Timeframe: Baseline and Week 72 21. Percent Change from Baseline at Week 72 in Fasting Concentration of Low-density Lipoprotein Cholesterol (LDL-C) Timeframe: Baseline and Week 72 22. Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C) Timeframe: Baseline and Week 72 23. Percent Change from Baseline at Week 72 in Fasting Concentration of High-density Lipoprotein Cholesterol (HDL-C) Timeframe: Baseline and Week 72 24. Change from Baseline in Diastolic Blood Pressure DBP at Week 72 Timeframe: Baseline and Week 72 25. Change from Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72 Timeframe: Baseline and Week 72 And 3 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 99 Years **Healthy volunteers** No ### Inclusion criteria - Age ≥ 18 years. - Body mass index ≥ 27 kg/m^2. - History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. - Diagnosis of T2DM. ### Exclusion criteria - Type 1 diabetes mellitus. - Self-reported change in body weight > 5 kg within 90 days before screening. - Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment. - Obesity induced by other endocrinologic disorders. - Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2. - History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening. - History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening. - Lifetime history of suicide attempt. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) ## Sites - Alliance for Multispecialty Research MobileMobile, United States - Gilbert Center for Family MedicineGilbert, United States - Desert Clinical ResearchMesa, United States - Avacare Foothills Research CenterPhoenix, United States - San Fernando Valley Health InstituteCanoga Park, United States - Core Healthcare GroupCerritos, United States - Velocity Clinical Research Chula VistaChula Vista, United States - Headlands Research CaliforniaEscondido, United States - Paradigm Clinical ResearchModesto, United States - Flourish ResearchNorthridge, United States - University of California IrvineOrange, United States - Empire Clinical ResearchPomona, United States - Infinity Clinical TrialsSan Diego, United States - Greenwich Clinical TrialsRiverside, United States - Indago Research and Health CenterHialeah, United States - Optimus U CorporationMiami, United States - New Horizon Research CenterMiami, United States - San Marcus Research Clinic IncMiami Lakes, United States - Florida Institute for Clinical ResearchOrlando, United States - Encore Medical Research of Weston LLCWeston, United States - Conquest Research - Winter ParkWinter Park, United States - Alliance For Multispecialty Research - Oak BrookOak Brook, United States - Alliance for Multispecialty Research, LLC - Park RidgePark Ridge, United States - Endeavor Health Medical Group - Endocrinology and Diabetes- SkokieSkokie, United States - Indiana Medical Research InstituteMerrillville, United States And 162 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) ## References - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858878) ## 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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