MARITIME-HF

RecruitingPhase 3

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

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)

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

605

Recruiting sites

603

Enrollment

5,056

estimated

Study population

Heart failure, Obesity / overweight

Key I/E criteria

•BMI ≥30•EF ≥40%

Primary endpoint

•Expanded / custom MACE composite (Cardiovascular death, Heart-failure hospitalization, Urgent heart-failure visit)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07037459

Org study ID20230227

Timeline

Milestones

Study first posted2025-06-25actual

Study start2025-06-25actual

Last update posted2026-05-22actual

Primary completion2028-06-30estimated

Study completion2030-09-29estimated

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Study populations

Who this study enrolls

Heart failureObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age99 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age ≥ 18 years at the time of informed consent.

•BMI ≥ 30.0 kg/m^2 at the time of randomization.

•HF diagnosed for at least 30 days with New York Heart Association (NYHA) Class II-IV at the time of informed consent.

•Managed with HF standard of care therapies.

•Left ventricular ejection fraction (LVEF) of > 40% within 12 months from the beginning of screening.

•Elevated NT-proBNP.

•Participants must have at least one of the following:

1. Structural heart disease within 12 months prior to screening OR

2. Documented hospitalization with a primary diagnosis of decompensated HF which required IV loop diuretic treatment > 30 days and < 12 months prior to randomization OR

3. Evidence of elevated filling pressures within 12 months before randomization.

Exclusion criteria

•History of any of the following within 60 days prior to or during screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke.

•HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.

•Any lifetime history of LVEF ≤ 40%.

•Hospitalized with acute decompensated HF at the time of or during the screening period.

•Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.

•For participants with a prior diagnosis of T2DM (including those diagnosed during screening):

1. HbA1c > 10.0% (86 mmol/mol) at screening

2. Uncontrolled diabetes requiring immediate therapy

3. History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization

4. One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness

5. History or presence of either proliferative diabetic retinopathy, or diabetic maculopathy, or severe non-proliferative diabetic retinopathy; or currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.

•SBP ≥ 180 mmHg during the screening period, or on three or more blood pressure-lowering drugs with a SBP > 160 mmHg during the screening period.

•History of chronic pancreatitis or acute pancreatitis in the 180 days before screening or during the screening period.

•Any personal lifetime history of, or family history(first-degree relative[s]) of medullary thyroid carcinoma or MEN-2.

•eGFR < 20 mL/min/1.73 m^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.

•Calcitonin ≥ 50 ng/L (pg/mL) at screening.

•Acute or chronic hepatitis.

•Any of the following psychiatric history:

1. History of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior to screening or during the screening period

2. Lifetime history of suicide attempt

3. History of non-suicidal self-injury within 5 years prior to screening or during the screening period.

•History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the trial.

•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 prior to or during the screening period or planned use during the conduct of the trial.

Endpoints (33)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Heart failure

Cardiovascular outcomes

Cardiometabolic biomarkers

Renal / kidney

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Cardiovascular outcomes

6 endpoints

Primary/protocol endpoint

Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF Events

Time frame:Up to approximately 35 months

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, Heart-failure hospitalization, Urgent heart-failure visit

Secondary/protocol endpoint

Time to First Occurrence of a Composite Endpoint Consisting of: Myocardial Infarction (MI), Ischemic Stroke, CV Death (Major Adverse Cardiac Events [MACE]), or HF Events

Time frame:Up to approximately 35 months

4-point MACE

time to event, event

componentsNon-fatal MI, Ischemic stroke, Cardiovascular death, Heart-failure hospitalization

Secondary/protocol endpoint

Total All-cause Hospitalizations (First and Recurrent Time to Event)

Time frame:Up to approximately 35 months

All-cause hospitalization

event count, event

Secondary/protocol endpoint

Time to All-cause Death

Time frame:Up to approximately 35 months

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Time to CV Death

Time frame:Up to Approximately 35 Months

Cardiovascular death

time to event, event

Secondary/protocol endpoint

Time to New Onset of Atrial Fibrillation (AF) or Atrial Flutter (AFL) in Participants Without a History of AF or AFL at Baseline

Time frame:Baseline and up to approximately 35 months

Atrial-fibrillation composite

time to event, event

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI) (kg/m^2)

Time frame:Baseline and Week 72

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the Waist Circumference (cm)

Time frame:Baseline and Week 72

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in the Body Weight (kg)

Time frame:Baseline and Week 72

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Time to Onset of Type 2 Diabetes Mellitus (T2DM) in Participants with Prediabetes

Time frame:Up to approximately 35 months

Time to T2DM onset

time to event, event

Secondary/protocol endpoint

Change from Baseline in the Hemoglobin A1c (HbA1c [%, mmol/mol]) in Participants with T2DM

Time frame:Baseline and Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Heart failure

11 endpoints

Secondary/protocol endpoint

Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) for Participants with Baseline KCCQ-CSS Score ≤ 80

Time frame:Baseline and Week 48

KCCQ clinical summary

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the KCCQ Total Symptom Score (TSS) for Participants with Baseline KCCQ-CSS Score ≤ 80

Time frame:Baseline and Week 48

change from baseline, improvement

Secondary/protocol endpoint

Total Number of HF Events Including First and Recurrent HF Events

Time frame:Up to approximately 35 months

Heart-failure hospitalization

event count, event

SNOMED 84114007

Secondary/protocol endpoint

Time to the First HF Event

Time frame:Up to approximately 35 months

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Secondary/protocol endpoint

Number of Participants Achieving ≥ 5-point Change in KCCQ-CSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80

Time frame:Baseline and Week 48

KCCQ clinical summary

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Achieving ≥ 10-point Change in KCCQ-CSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80

Time frame:Baseline and Week 48

KCCQ clinical summary

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Achieving an Anchor-based Change in KCCQ-CSS Score From Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80

Time frame:Baseline and Week 48

KCCQ clinical summary

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Achieving ≥ 5-point Change in KCCQ-TSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80

Time frame:Baseline and Week 48

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Achieving ≥ 10-point Change in KCCQ-TSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80

Time frame:Baseline and Week 48

KCCQ total score

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Achieving an Anchor-based Change in KCCQ-TSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80

Time frame:Baseline and Week 48

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in N-terminal Pro B Type Natriuretic Peptide (NT-proBNP)

Time frame:Baseline and Week 72

NT-proBNP, change

change from baseline, improvement

Renal / kidney

4 endpoints

Secondary/protocol endpoint

Time to First Event of a Composite Nephropathy Endpoint

Time frame:Up to approximately 35 months

Custom renal composite

time to event, event

componentsuACR, change, eGFR, change, End-stage renal disease, Kidney-replacement therapy, Renal death, Cardiovascular death

Secondary/protocol endpoint

Change in eGFR Slope (Total)

Time frame:Baseline up to approximately 35 months

eGFR slope (total)

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in eGFR Slope (Chronic)

Time frame:From 4 months up to approximately 35 months

eGFR slope (chronic)

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change from Baseline in the Urine Albumin-to-creatinine Ratio (uACR)

Time frame:Baseline and Week 72

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Change from Baseline in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Time frame:Baseline and Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Percent Change from Baseline in the High-sensitivity C Reactive Protein (hs-CRP)

Time frame:Baseline and Week 72

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Percent Change from Baseline in Total Cholesterol

Time frame:Baseline and Week 72

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percent Change from Baseline in Non-high-density Lipoprotein Cholesterol (non-HDL-C)

Time frame:Baseline and Week 72

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C), HDL-C, Triglycerides (TG), Very Low-density Lipoprotein Cholesterol (VLDL-C)

Time frame:Baseline and Week 72

percent change from baseline, improvement

componentsLDL-C, change, HDL-C, change, Triglycerides, change, VLDL, change

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events

Time frame:Up to approximately 35 months

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Plasma Concentration of Maridebart Cafraglutide

Time frame:Week 72

Plasma concentration (steady state)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.