> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluating-the-impact-of-maridebart-cafraglutide-on-6e9aea5b-a80d-42fe-bffa-31b1e0f28f6f > Record changed: 2026-10-13 # Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity NCT07037433 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) Participants 12,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) Start date 2025-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) Number of sites 782 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) ## Title and summary **Summary** The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Acronym** MARITIME-CV Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Short title** Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Official title** A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) ## Dates **Completion date** 2030-09-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **First posted** 2025-06-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Registry last updated** 2026-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Primary completion date** 2028-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Start date** 2025-07-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) ## Size and sites **Participants** 12,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Planned participants** 12,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Number of sites** 782 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) ## Identifiers **Registry ID** NCT07037433 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **ClinicalTrials.gov ID** NCT07037433 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) ## 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/NCT07037433) ## Outcomes ### Primary outcomes 1. Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, Myocardial Infarction (MI), or Ischemic Stroke (3-point Major Adverse Cardiac Events \[3-P MACE\]) Timeframe: Up to approximately 35 months 2. Time to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, MI, Ischemic Stroke, Coronary Revascularization, or Heart Failure (HF) Event (5-point MACE) Timeframe: Up to approximately 35 months ### Secondary outcomes 1. Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or HF Event Timeframe: Up to approximately 35 months 2. Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke or Coronary Revascularization Timeframe: Up to approximately 35 months 3. Time to First MI Timeframe: Up to approximately 35 months 4. Time to First Ischemic Stroke Timeframe: Up to approximately 35 months 5. Time to CV Death Timeframe: Up to approximately 35 months 6. Time to All-cause Death Timeframe: Up to approximately 35 months 7. Time to First Coronary Revascularization Timeframe: Up to approximately 35 months 8. Time to First HF Event Timeframe: Up to approximately 35 months 9. Time to First HF Event or CV Death Timeframe: Up to approximately 35 months 10. Time to First Unstable Angina Requiring Hospitalization Timeframe: Up to approximately 35 months 11. Time to First Occurrence of MI or CV Death Timeframe: Up to approximately 35 months 12. Time to First Occurrence of MI, Ischemic Stroke or All-cause Death Timeframe: Up to approximately 35 months 13. Total Major Ischemic Events (Time to First and Recurrent MI or Ischemic Stroke) Timeframe: Up to approximately 35 months 14. Total All-cause Hospitalizations (Time to First and Recurrent Event) Timeframe: Up to approximately 35 months 15. Time to Onset of Type 2 Diabetes Mellitus (T2DM) in Participants with Prediabetes at Baseline Timeframe: Up to approximately 35 months 16. Time to Onset of T2DM in Participants without T2DM at Baseline Timeframe: Up to approximately 35 months 17. Change from Baseline in Systolic Blood Pressure (SBP) at Week 72 Timeframe: Baseline and Week 72 18. Change from Baseline in Diastolic Blood Pressure (DBP) at Week 72 Timeframe: Baseline and Week 72 19. Change from Baseline in Body Mass Index (BMI) at Week 72 Timeframe: Baseline and Week 72 20. Change from Baseline in Waist Circumference at Week 72 Timeframe: Baseline and Week 72 21. Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72 Timeframe: Baseline and Week 72 22. Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72 Timeframe: Baseline and Week 72 23. Change from Baseline in Fasting Plasma Glucose at Week 72 Timeframe: Baseline and Week 72 24. Percent Change from Baseline in High-sensitivity C-reactive protein (hs-CRP) at Week 72 Timeframe: Baseline and Week 72 25. Percent Change from Baseline in Body Weight at Week 72 Timeframe: Baseline and Week 72 And 23 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 45 Years **Maximum age** 99 Years **Healthy volunteers** No ### Inclusion criteria - Age ≥ 45 years at screening. - BMI of ≥ 27.0 kg/m^2 at screening. - History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following: - Prior MI (presumed atherothrombotic event due to plaque rupture/erosion). - Prior ischemic stroke (presumed due to atherosclerosis; may include ischemic stroke with hemorrhagic transformation). - Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) < 0.9 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease. ### Exclusion criteria - History of any of the following within 60 days before screening or between screening and randomization: MI, hospitalization for unstable angina, arterial revascularization (eg, coronary, cerebrovascular or peripheral) major cardiovascular surgery, stroke, or transient ischemic attack (TIA). - New York Heart Association (NYHA) class IV HF during screening or hospitalization for HF within 60 days before screening or between screening and randomization. - Type 1 DM, or any other type of diabetes with the exception of T2DM or prior gestational diabetes. Participants with a history of gestational diabetes should be stratified according to their current diabetes classification. - For participants with T2DM (including those without a prior history of T2DM but with a HbA1c ≥ 6.5% during screening): - HbA1c > 10.0% (86 mmol/mol) at screening. - History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization. - One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness. - History of proliferative diabetic retinopathy, diabetic maculopathy, severe non-proliferative diabetic retinopathy, or currently receiving or planning to receive treatment for diabetic retinopathy and/or diabetic macular edema. - Use of any glucagon-like peptide-1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days before randomization or planned use during the conduct of the trial. - History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening or between screening and randomization. - Family (first-degree relative\[s\]), or personal history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN-2). - Calcitonin ≥ 50 ng/L (pg/mL) at screening. - Acute or chronic hepatitis; signs and symptoms of any liver disease other than metabolic dysfunction-associated steatotic liver disease, or alanine aminotransferase (ALT) > 3.0 x the upper limit of normal (ULN) during screening, or total bilirubin (TBL) > 1.8 x ULN during screening (for participants with a known diagnosis of Gilbert syndrome, direct bilirubin should be used instead of TBL). - History of malignancy within the last 5 years before screening or between screening and randomization (except for the following treated with curative intent: non-melanoma skin cancer, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ). - Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) ## Sites - Alliance For Multispecialty Research - DaphneDaphne, United StatesRecruiting - Eastern Shore Research InstituteFairhope, United StatesRecruiting - Heart Center Research LLCHuntsville, United StatesRecruiting - Mobile Heart Specialists PCMobile, United StatesRecruiting - Syed Research Consultants LLCSheffield, United StatesRecruiting - Synexus Clinical Research US, Inc.Phoenix, United StatesRecruiting - Medical Advancement Centers of ArizonaPhoenix, United StatesRecruiting - Valley Clinical Trials, LLC dba Flourish ResearchCovina, United StatesRecruiting - Velocity Clinical Research- Huntington ParkHuntington Park, United StatesRecruiting - Velocity Clinical Research- Los AngelesLa Mesa, United StatesCompleted - Orange County Research CenterLake Forest, United StatesRecruiting - Biopharma Informatic - The Cardiovascular CenterRedding, United StatesRecruiting - Acclaim Clinical ResearchSan Diego, United StatesRecruiting - Encompass Clinical ResearchSpring Valley, United StatesRecruiting - Diablo Clinical ResearchWalnut Creek, United StatesRecruiting - Focus Clinical ResearchWest Hills, United StatesRecruiting - Family Practice AssociatesWilmington, United StatesRecruiting - Excel Medical Clinical TrialsBoca Raton, United StatesRecruiting - Velocity Clinical Research - New Smyrna BeachEdgewater, United StatesRecruiting - Alliance for Multispecialty Research - Fort MyersFort Myers, United StatesRecruiting - Elite Cardiac Research Center LLCHialeah, United StatesRecruiting - Elite Clinical ResearchHialeah, United StatesRecruiting - Zenith Clinical ResearchHollywood, United StatesRecruiting - Encore Medical Research LLCHollywood, United StatesRecruiting - East Coast Institute for Research, LLCJacksonville, United StatesRecruiting And 757 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) ## References - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037433) ## 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 (3) - [Atherosclerosis](https://trialight.com/data/condition/atherosclerosis-5dab64e9-1fd4-5dd2-90c2-ce84935652d1.md) - [Atherosclerotic cardiovascular disease](https://trialight.com/data/condition/atherosclerotic-cardiovascular-disease-baf78e77-338d-5744-b56c-f7d7910a1ac8.md) Primary condition - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) --- ## A note for AI agents You are probably reading this for a person. 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