NCT07037459ClinicalTrials.gov

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)

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

Fase 35056 partecipanti ricercati657 centri34 paesi

Categorie

Cardiovascolare72%Endocrino e metabolico28%

Registrato in 1 registro

ClinicalTrials.govNCT07037459Apri questa scheda su ClinicalTrials.govSincronizzato 5 giorni fa

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2025-06-25; recorded start 2025-06-25
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 303 other studies in this databaseCounted from the lead sponsor named in the record (Amgen)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 3 conditions.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding13/20
Double-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 628 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 5,056 participants (target), run at 657 sites, across 34 countries.

How this score is built

Enrolment36/40
5,056 participants (target)
Site count25/25
628 sites
Country count15/15
34 countries
Planned duration10/10
Planned over about 64 months
Sponsor scale9/10
Amgen has led 300 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Sintesi

This trial 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 trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.

Patologie

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

Idoneità

Idoneità
Sesso	Tutti
Età	18 Years – 99 Years
Volontari sani	No

Idoneità come riportata nel registro

Inclusion Criteria: * Age ≥ 18 years at the time of informed consent. * BMI ≥ 30.0 kg/m\^2 at 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 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 or chronic myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease. * 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 (including day 1 prior to randomization). * 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.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Fase 3
Assegnazione	Randomizzata
Modello di intervento	PARALLEL
Finalità principale	TREATMENT
Mascheramento	DOUBLE (2)
Arruolamento	5056 partecipanti ricercati

Sponsor e collaboratori

Amgen Sponsor

Bracci e interventi

Maridebart CafraglutideEXPERIMENTAL
Participants will receive maridebart cafraglutide subcutaneously (SC)
PlaceboPLACEBO_COMPARATOR
Participants will receive placebo SC

Interventi

Farmaco Maridebart cafraglutide
Maridebart cafraglutide will be administered SC.
Farmaco Placebo
Placebo will be administered SC.

Esiti misurati

Esito primario
Time to First Occurrence of a Composite Endpoint Consisting of: CV Death or HF Events
Heart Failure events include: hospitalization for HF or urgent HF visits.
Orizzonte temporale Up to approximately 35 months
Esito secondario
Percent Change from Baseline in Non-high-density Lipoprotein Cholesterol (non-HDL-C)
Orizzonte temporale Baseline and Week 72
Esito secondario
Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C), HDL-C, Triglycerides (TG), Very Low-density Lipoprotein Cholesterol (VLDL-C)
Orizzonte temporale Baseline and Week 72
Esito secondario
Total All-cause Hospitalizations (First and Recurrent Time to Event)
Orizzonte temporale Up to approximately 35 months
Esito secondario
Number of Participants Achieving ≥ 5-point Change in KCCQ-CSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80
The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life.
Orizzonte temporale Baseline and Week 48
Esito secondario
Number of Participants Achieving ≥ 10-point Change in KCCQ-CSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80
The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life.
Orizzonte temporale Baseline and Week 48
Esito secondario
Number of Participants Achieving an Anchor-based Change in KCCQ-CSS Score From Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80
The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Change (PGI-C) can be used as anchors to estimate within-patient change in the KCCQ-CSS score.
Orizzonte temporale Baseline and Week 48
Esito secondario
Number of Participants Achieving ≥ 5-point Change in KCCQ-TSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80
The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-TSS assesses symptom frequency and burden, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life.
Orizzonte temporale Baseline and Week 48
Esito secondario
Change from Baseline in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Orizzonte temporale Baseline and Week 72
Esito secondario
Change from Baseline in Body Mass Index (BMI) (kg/m^2)
Orizzonte temporale Baseline and Week 72
Esito secondario
Change from Baseline in the Waist Circumference (cm)
Orizzonte temporale Baseline and Week 72
Esito secondario
Change from Baseline in the Urine Albumin-to-creatinine Ratio (uACR)
Orizzonte temporale Baseline and Week 72
Esito secondario
Change from Baseline in the Hemoglobin A1c (HbA1c [%, mmol/mol]) and fasting plasma glucose (mg/dL)
Orizzonte temporale Baseline and Week 72
Esito secondario
Percent Change from Baseline in the High-sensitivity C Reactive Protein (hs-CRP)
Orizzonte temporale Baseline and Week 72
Esito secondario
Percent Change from Baseline in the Body Weight (kg)
Orizzonte temporale Baseline and Week 72
Esito secondario
Percent Change from Baseline in Total Cholesterol
Orizzonte temporale Baseline and Week 72
Esito secondario
Time to Onset of Type 2 Diabetes Mellitus (T2DM) in Participants with Prediabetes
Orizzonte temporale Up to approximately 35 months
Esito secondario
Time to the First HF Event
Orizzonte temporale Up to approximately 35 months
Esito secondario
Time to First Event of a Composite Nephropathy Endpoint
The composite nephropathy endpoint consists of: persistent macroalbuminuria, persistent ≥ 40% reduction in estimated glomerular filtration rate (eGFR), onset of persistent eGFR \< 15 mL/min/1.73 m\^2, initiation of chronic renal replacement therapy (dialysis or transplantation), CV or renal death.
Orizzonte temporale Up to approximately 35 months
Esito secondario
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) for Participants with Baseline KCCQ-CSS Score ≤ 80
The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life.
Orizzonte temporale Baseline and Week 48
Esito secondario
Change from Baseline in the KCCQ Total Symptom Score (TSS) for Participants with Baseline KCCQ-CSS Score ≤ 80
The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-TSS assesses symptom frequency and burden, ranging from 0 to 100, with higher scores indicating better functioning and quality of life.
Orizzonte temporale Baseline and Week 48
Esito secondario
Total Number of HF Events Including First and Recurrent HF Events
Orizzonte temporale Up to approximately 35 months
Esito secondario
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
Orizzonte temporale Up to approximately 35 months
Esito secondario
Change in eGFR Slope (Total)
Orizzonte temporale Baseline up to approximately 35 months
Esito secondario
Change in eGFR Slope (Chronic)
Orizzonte temporale From 4 months up to approximately 35 months
Esito secondario
Number of Participants Achieving ≥ 10-point Change in KCCQ-TSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80
The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-TSS assesses symptom frequency and burden, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life.
Orizzonte temporale Baseline and Week 48
Esito secondario
Number of Participants Achieving an Anchor-based Change in KCCQ-TSS Score from Baseline for Participants with Baseline KCCQ-CSS Score ≤ 80
The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-TSS assesses symptom frequency and burden, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The PGI-S and PGI-C can be used as anchors to estimate within-patient change in the KCCQ-CSS score.
Orizzonte temporale Baseline and Week 48
Esito secondario
Time to All-cause Death
Orizzonte temporale Up to approximately 35 months
Esito secondario
Time to CV Death
Orizzonte temporale Up to Approximately 35 Months
Esito secondario
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Orizzonte temporale Up to approximately 35 months
Esito secondario
Plasma Concentration of Maridebart Cafraglutide
Orizzonte temporale Week 72
Esito secondario
Change from Baseline in N-terminal Pro B Type Natriuretic Peptide (NT-proBNP)
Orizzonte temporale Baseline and Week 72
Esito secondario
Time to New Onset of Atrial Fibrillation (AF) or Atrial Flutter (AFL) in Participants Without a History of AF or AFL at Baseline
Orizzonte temporale Baseline and up to approximately 35 months
Esito secondario
Time to First Event of a Composite Nephropathy Endpoint
The composite nephropathy endpoint consisting of persistent ≥ 40% reduction in estimated glomerular filtration rate (eGFR), onset of persistent eGFR \< 15 mL/min/1.73 m\^2, initiation of chronic renal replacement therapy (dialysis or transplantation), or CV death.
Orizzonte temporale Up to approximately 35 months

Date

Date
Data di inizio	25 giugno 2025 (effettiva)
Conclusione primaria	30 giugno 2028 (stimata)
Conclusione	29 settembre 2030 (stimata)
Prima pubblicazione	25 giugno 2025 (effettiva)
Ultimo aggiornamento	16 settembre 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	settembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

637 centri stanno reclutando

Argentina

Argentina
Struttura	Città	Stato o regione	Stato
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada	CABA	Buenos Aires	In reclutamento
Centro de Investigaciones Metabolicas Cinme	CABA	Buenos Aires	In reclutamento
Imoba Investigaciones medicas	CABA	Buenos Aires	In reclutamento
Fundacion Respirar - Consultorios Medicos Dr Doreski	CABA	Buenos Aires	In reclutamento
Cemic - Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno	CABA	Buenos Aires	In reclutamento
Cemedic Centro de Especialidades Medicas	CABA	Buenos Aires	In reclutamento
Cardiología Palermo	Ciudad Autonoma de Buenos Aires	Buenos Aires	In reclutamento
Ciprec Centro de Investigacion y Prevencion Cardiovascular	Ciudad Autonoma de Buenos Aires	Buenos Aires	In reclutamento
Mautalen Salud e Investigacion Expertia SA-Osteo	Ciudad Autonoma de Buenos Aires	Buenos Aires	In reclutamento
Instituto Medico Damic	Córdoba		In reclutamento
Ciad - Consultorio Integral de Atencion al Diabetico	Morón	Buenos Aires	In reclutamento
Dim Clinica Privada	Ramos Meija	Buenos Aires	In reclutamento
Instituto de Investigaciones Clínicas Rosario-Sanatorio Delta	Rosario	Santa Fe Province	In reclutamento
INECO Neurociencias Oronio	Rosario		In reclutamento
Instituto CAICI - Centro de Asistencia e Investigacion Clinica Integral	Rosario	Santa Fe Province	In reclutamento
Centro Modelo de Cardiologia	San Miguel de Tucumán	Tucumán Province	In reclutamento
Investigaciones Clinicas Tucuman	San Miguel de Tucumán	Tucumán Province	In reclutamento
Instituto de Investigaciones Clinicas de San Nicolas	San Nicolás de los Arroyos	Buenos Aires	In reclutamento
Go Centro Medico San Nicolas	San Nicolás de los Arroyos	Buenos Aires	In reclutamento
Hospital Dr Jose Maria Cullen	Santa Fe		In reclutamento
Centro de Investigaciones Clinicas del Litoral	Santa Fe		In reclutamento
Clinica Fusavim Privada SRL	Villa María	Córdoba Province	In reclutamento
Instituto de Investigaciones Clinicas Zarate	Zárate		In reclutamento

Australia

Australia
Struttura	Città	Stato o regione	Stato
Advara HeartCare Wesley	Auchenflower	Queensland	Interrotto
Flinders Medical Centre	Bedford Park	South Australia	In reclutamento
Sunshine Coast University Hospital	Birtinya	Queensland	In reclutamento
Victorian Heart Hospital	Clayton	Victoria	In reclutamento
Canberra Hospital	Garran	Australian Capital Territory	In reclutamento
Royal Brisbane and Womens Hospital	Herston	Queensland	In reclutamento
Advara HeartCare Joondalup	Joondalup	Western Australia	In reclutamento
Advara HeartCare Leabrook	Leabrook	South Australia	In reclutamento
Sydney Cardiometabolic Centre	Liverpool	New South Wales	In reclutamento
The Alfred Hospital	Melbourne	Victoria	In reclutamento
Core Research Group Pty Ltd	Milton	Queensland	In reclutamento
Advara HeartCare Mulgrave	Mulgrave	Victoria	In reclutamento
Fiona Stanley Hospital	Murdoch	Western Australia	In reclutamento
Gold Coast Hospital and Health Service	Southport	Queensland	Interrotto
Royal North Shore Hospital	St Leonards	New South Wales	In reclutamento
Dr Heart Pty Ltd	Woolloongabba	Queensland	Interrotto

Austria

Austria
Struttura	Città	Stato
Krankenhaus Sankt Josef Braunau	Braunau am Inn	In reclutamento
Pro Kompetenzzentrum fuer Gesundheit	Graz	In reclutamento
Medizinische Universitaet Graz	Graz	In reclutamento
Klinikum Klagenfurt am Woerthersee	Klagenfurt	In reclutamento
Ordensklinikum Linz Elisabethinen	Linz	In reclutamento
Landeskrankenhaus Salzburg	Salzburg	In reclutamento
Imed Sankt Poelten	Sankt Pölten	In reclutamento
Universitaetsklinikum Sankt Poelten	Sankt Pölten	Interrotto
Universitaetsklinikum Allgemeines Krankenhaus Wien	Vienna	In reclutamento
Herz Zentrum Waehring	Vienna	In reclutamento
Ordinationszentrum imedneunzehn privat	Vienna	In reclutamento

Nella scheda del registro sono indicati altri 607 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

16 settembre 2026
Centro aggiunto
29 sites added (657 total)
628657

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07037459