RECRUITING

Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part study with a double-blind period and an open-label extension (OLE). The study is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.

Official Title

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)

Quick Facts

Study Start:2025-06-25
Study Completion:2030-09-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07037459

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years.
  2. * BMI ≥ 30 kg/m\^2.
  3. * HF diagnosed for at least 30 days before screening with New York Heart Association (NYHA) Class II-IV.
  4. * Managed with HF standard of care therapies.
  5. * Left ventricular ejection fraction (LVEF) of \> 40%.
  6. * Elevated NT-proBNP.
  7. * Participants must have at least one of the following:
  8. 1. Structural heart disease OR
  9. 2. Documented hospitalization with a primary diagnosis of decompensated HF within 12 months before randomization OR
  10. 3. Evidence of elevated filling pressures within 12 months before randomization.
  1. * History of any of the following within 60 days before screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke.
  2. * HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular heart disease, or clinically significant congenital heart disease.
  3. * Any lifetime history of LVEF ≤ 40%.
  4. * Currently hospitalized with acute decompensated HF or hospitalization with a primary diagnosis of decompensated HF within 30 days before screening.
  5. * Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.
  6. * For participants with a prior diagnosis of T2DM at screening:
  7. 1. HbA1c \> 10.0%
  8. 2. Uncontrolled diabetes requiring immediate therapy
  9. 3. History of diabetic ketoacidosis or hyperosmolar state/coma
  10. 4. One or more episodes of severe hypoglycemia within 6 months before screening and/or history of hypoglycemia unawareness
  11. 5. History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.
  12. * SBP ≥ 180 mmHg , or on three or more blood pressure-lowering drugs with a SBP \> 160 mmHg.
  13. * History of chronic pancreatitis or acute pancreatitis in the 180 days before screening.
  14. * Family (or personal) history of medullary thyroid carcinoma or MEN-2.
  15. * eGFR \< 20 mL/min/1.73 m\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.
  16. * Calcitonin ≥ 50 ng/L (pg/mL) at screening.
  17. * Acute or chronic hepatitis.
  18. * Any of the following psychiatric history:
  19. 1. History of unstable major depressive disorder or other severe psychiatric disorder within 2 years before screening
  20. 2. Lifetime history of suicide attempt
  21. 3. History of non-suicidal self-injury within 5 years before screening.
  22. * History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the study.
  23. * 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 study.

Contacts and Locations

Study Contact

Amgen Call Center
CONTACT
866-572-6436
medinfo@amgen.com

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Valley Clinical Trials
Northridge, California, 91325
United States
NorthBay Clinical Research LLC
Santa Rosa, California, 95405
United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
United States
Ocala Cardiovascular Research
Ocala, Florida, 34471
United States
Northshore Heart and Vascular LLC
Mandeville, Louisiana, 70448
United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, 37388
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-25
Study Completion Date2030-09-29

Study Record Updates

Study Start Date2025-06-25
Study Completion Date2030-09-29

Terms related to this study

Keywords Provided by Researchers

  • Heart Failure
  • Obesity
  • Maridebart Cafraglutide
  • AMG 133
  • MariTide

Additional Relevant MeSH Terms

  • Heart Failure With Preserved Ejection Fraction
  • Heart Failure With Mildly Reduced Ejection Fraction
  • Obesity