> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/maridebart-cafraglutide-versus-semaglutide-in-participants-e01e2377-86c1-4442-8aef-155173a27667 > Record changed: 2026-11-04 # Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes NCT07866066 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) Participants 1,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) Start date 2026-11-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) ## Title and summary **Summary** The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Acronym** MARITIME-T2D-3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Short title** Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Official title** A Phase 3, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Maridebart Cafraglutide Once Monthly Versus Semaglutide Once Weekly as Add-on Therapy to Metformin With or Without a Sodium-glucose Cotransporter-2 Inhibitor in Participants With Type 2 Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) ## Dates **Completion date** 2028-12-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **First posted** 2026-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Registry last updated** 2026-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Primary completion date** 2028-09-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Start date** 2026-11-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) ## Size and sites **Participants** 1,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Planned participants** 1,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) ## Identifiers **Registry ID** NCT07866066 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **ClinicalTrials.gov ID** NCT07866066 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) ## Outcomes ### Primary outcomes 1. Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 \[Non-inferiority\] Timeframe: Baseline to Week 68 ### Secondary outcomes 1. Change from Baseline in HbA1c at week 68 \[Superiority\] Timeframe: Baseline to Week 68 2. Percent Change from Baseline in Body Weight at Week 68 Timeframe: Baseline to Week 68 3. Percentage of Participants Achieving HbA1c < 7.0% at Week 68 Timeframe: Week 68 4. Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68 Timeframe: Week 68 5. Percentage of Participants Achieving HbA1c < 5.7% at Week 68 Timeframe: Week 68 6. Change from Baseline in Fasting Plasma Glucose at Week 68 Timeframe: Baseline to Week 68 7. Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline at Week 68 Timeframe: Baseline to Week 68 8. Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 68 Timeframe: Baseline to Week 68 9. Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 68 Timeframe: Baseline to Week 68 10. Percentage of Participants Achieving HbA1c ≤ 6.5% and Weight Reduction ≥ 10% from Baseline at Week 68 Timeframe: Baseline to Week 68 11. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Timeframe: Up To 81 Weeks 12. Number of Participants Experiencing ≥ Level 2 American Diabetes Association (ADA) Defined Hypoglycemic Episodes Timeframe: Up To 81 Weeks 13. Plasma Concentration of Maridebart Cafraglutide at Week 68 Timeframe: Week 68 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening. - Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose cotransporter-2 (SGLT-2) inhibitor on a stable total daily dose for at least 90 days prior to randomization. - Body mass index (BMI) ≥ 25 kilograms per meter squared (kg/m^2) at screening. ### Exclusion criteria - Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus except T2D or past history of gestational diabetes. - Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema. - Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy. - One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery. - History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. - Self-reported change in body weight > 5% within 90 days before screening. Participants must also agree to not initiate an intensive diet or exercise program during the trial with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment. - Previous or planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. The following are allowed: - liposuction and/or abdominoplasty that was performed > 1 year before screening. - laparoscopic adjustable gastric banding, intragastric balloon, and/or duodenal-jejunal bypass liner or gastric sleeve if removed > 1 year before screening. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) ## References - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) ### Other registry identifiers (2) - 2025 - 2025-523772-22-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07866066) ## Related records ### Drugs (2) - [Maridebart cafraglutide](https://trialight.com/data/asset/maridebart-cafraglutide-ed4d163f-9dd6-42fa-9ba3-bc4358617867.md) - [Semaglutide](https://trialight.com/data/asset/semaglutide-0f0980aa-d386-4209-8f14-80da83c40d80.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 ### Targets (2) - [GIPR](https://trialight.com/data/target/gipr-5b65dd73-9875-5aca-be7a-5469a7290f0c.md) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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