> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/extension-trial-to-evaluate-the-long-term-efficacy-safety-8fefbb8c-85f8-47cc-a5b0-ce60a3f8a0ad > Record changed: 2026-11-04 # Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION) NCT07684144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) Participants 950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) Start date 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) Number of sites 45 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) ## Title and summary **Summary** The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Short title** Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Official title** A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight With Type 2 Diabetes Mellitus Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) ## Dates **Completion date** 2028-03-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **First posted** 2026-07-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Registry last updated** 2026-10-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Primary completion date** 2027-12-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Start date** 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) ## Size and sites **Participants** 950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Planned participants** 950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Number of sites** 45 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) ## Identifiers **Registry ID** NCT07684144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **ClinicalTrials.gov ID** NCT07684144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) ## 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/NCT07684144) ## Outcomes ### Primary outcomes 1. Percent Change in Body Weight from Baseline of the Parent Trial (20210184) Timeframe: Baseline of parent trial (20210184) to Week 48 of current trial 2. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Timeframe: Baseline of current trial up to 60 weeks ### Secondary outcomes 1. Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline of the Parent Trial Timeframe: Baseline of parent trial to Week 48 of current trial 2. Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline of the Parent Trial Timeframe: Baseline of parent trial to Week 48 of current trial 3. Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline of the Parent Trial Timeframe: Baseline of parent trial to Week 48 of current trial 4. Percentage of Participants Achieving ≥ 20% Reduction in Body Weight from Baseline of the Parent Trial Timeframe: Baseline of parent trial to Week 48 of current trial 5. Change from Baseline of the Parent Trial in Hemoglobin A1c Timeframe: Baseline of parent trial to Week 48 of current trial 6. Change from Baseline of the Parent Trial in Waist Circumference Timeframe: Baseline of parent trial to Week 48 of current trial 7. Change from Baseline of the Parent Trial in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score Timeframe: Baseline of parent trial to Week 48 of current trial 8. Percent Change from Baseline in Body Weight Timeframe: Baseline of current trial to Week 48 9. Percentage of Participants with No Body Weight Gain of >3% From Baseline Timeframe: Week 48 of current trial 10. Percentage of Participants with No Body Weight Gain of >5% From Baseline Timeframe: Week 48 of current trial 11. Percentage of Body Weight Reduction Maintained from the Parent Trial Timeframe: Baseline of parent trial to Week 48 of current trial 12. Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved in the Parent Trial Timeframe: Baseline of parent trial to Week 48 of current trial 13. Change from Baseline in HbA1c Timeframe: Week 48 of current trial Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 99 Years **Healthy volunteers** No ### Inclusion criteria - Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol. - Participants completing Study 20210184 must meet the following criteria: - Completed the Week 72 visit in Study 20210184. - Did not permanently discontinue the investigational product in the parent trial (20210184). - Randomized within 7 days of week 72 visit in the parent trial. - Participants must use protocol-specified contraception during treatment and for 16 weeks after the last dose of trial intervention. ### Exclusion criteria - Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. - Body mass index (BMI) ≤ 18.5 kilograms per meter square (kg/m^2). - Participant has known sensitivity to any of the products or components to be administered during dosing. - History of ischemic optic neuropathy. - Any malignancy diagnosed during the parent trial, except for the following treated with curative intent: - Nonmelanoma skin cancers - Breast ductal carcinoma in situ - Cervical carcinoma in situ - Prostate cancer in situ - Newly identified (during the parent trial) multiple endocrine neoplasia syndrome type 2, or family history (first-degree relative\[s\]) history of medullary thyroid carcinoma (MTC). - Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at the Week 72 visit from the parent trial (20210184) before randomization. - Any suicidal ideation (category 4 or 5) or any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS), Since Last Visit version, at the Week 72 visit from the parent trial before randomization. - Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator. - History or evidence of any other clinically significant disorder, condition, disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial) that, in the opinion of the investigator, would pose a risk to participant safety. - Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or planning to become pregnant or breastfeed while on trial until an additional 16 weeks after the last dose of trial intervention. - Major surgical procedures planned during the trial. - Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the trial may be eligible at the discretion of the investigator. - Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) ## Sites - Gilbert Center for Family MedicineGilbert, United StatesRecruiting - San Fernando Valley Health InstituteCanoga Park, United StatesRecruiting - Core Healthcare GroupCerritos, United StatesRecruiting - Velocity Clinical Research Chula VistaLa Mesa, United StatesRecruiting - Paradigm Clinical ResearchModesto, United StatesRecruiting - Empire Clinical ResearchPomona, United StatesRecruiting - San Marcus Research Clinic IncMiami, United StatesRecruiting - Optimus U CorporationMiami, United StatesRecruiting - Indago Research and Health CenterMiami Lakes, United StatesRecruiting - Florida Institute for Clinical ResearchOrlando, United StatesRecruiting - Encore Medical Research of Weston LLCWeston, United StatesRecruiting - Conquest Research - Winter ParkWinter Park, United StatesRecruiting - Endeavor HealthSkokie, United StatesRecruiting - Iowa Diabetes ResearchWest Des Moines, United StatesRecruiting - JCCT- Juno Northwest HoustonLenexa, United StatesRecruiting - Alliance for Multispecialty Research NewtonNewton, United StatesRecruiting - Alliance for Multispecialty Research LLCWichita, United StatesRecruiting - Ima Clinical Research- MonroeMonroe, United StatesRecruiting - Annapolis Internal Medicine, LLCAnnapolis, United StatesRecruiting - Alliance for Multispecialty Research - Kansas CityKansas City, United StatesRecruiting - Palm Research Center IncLas Vegas, United StatesRecruiting - Premier ResearchTrenton, United StatesRecruiting - West Clinical ResearchMorehead City, United StatesRecruiting - Velocity Clinical Research - CincinnatiCincinnati, United StatesRecruiting - Velocity Clinical Research - SpringdaleCincinnati, United StatesRecruiting And 20 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) ## References - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) ### Other registry identifiers (3) - 2025 - 2025-524788-19-00 - U1111-1332-0531 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07684144) ## 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) Primary condition - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) ### 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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