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)

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En resumen

Fase 35056 participantes buscados657 centros34 países

Categorías

Cardiovascular72%Endocrino y metabólico28%

Registrado en 1 registro

ClinicalTrials.govNCT07037459Abrir este registro en ClinicalTrials.govSincronizado hace 5 días

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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.

Resumen

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.

Afecciones

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

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	18 Years – 99 Years
Voluntarios sanos	No

Elegibilidad tal como figura en el 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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 3
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	DOUBLE (2)
Inscripción	5056 participantes buscados

Patrocinador y colaboradores

Amgen Patrocinador

Grupos e intervenciones

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

Intervenciones

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

Variables de resultado

Variable de resultado principal
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.
Plazo Up to approximately 35 months
Variable de resultado secundaria
Percent Change from Baseline in Non-high-density Lipoprotein Cholesterol (non-HDL-C)
Plazo Baseline and Week 72
Variable de resultado secundaria
Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C), HDL-C, Triglycerides (TG), Very Low-density Lipoprotein Cholesterol (VLDL-C)
Plazo Baseline and Week 72
Variable de resultado secundaria
Total All-cause Hospitalizations (First and Recurrent Time to Event)
Plazo Up to approximately 35 months
Variable de resultado secundaria
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.
Plazo Baseline and Week 48
Variable de resultado secundaria
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.
Plazo Baseline and Week 48
Variable de resultado secundaria
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.
Plazo Baseline and Week 48
Variable de resultado secundaria
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.
Plazo Baseline and Week 48
Variable de resultado secundaria
Change from Baseline in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Plazo Baseline and Week 72
Variable de resultado secundaria
Change from Baseline in Body Mass Index (BMI) (kg/m^2)
Plazo Baseline and Week 72
Variable de resultado secundaria
Change from Baseline in the Waist Circumference (cm)
Plazo Baseline and Week 72
Variable de resultado secundaria
Change from Baseline in the Urine Albumin-to-creatinine Ratio (uACR)
Plazo Baseline and Week 72
Variable de resultado secundaria
Change from Baseline in the Hemoglobin A1c (HbA1c [%, mmol/mol]) and fasting plasma glucose (mg/dL)
Plazo Baseline and Week 72
Variable de resultado secundaria
Percent Change from Baseline in the High-sensitivity C Reactive Protein (hs-CRP)
Plazo Baseline and Week 72
Variable de resultado secundaria
Percent Change from Baseline in the Body Weight (kg)
Plazo Baseline and Week 72
Variable de resultado secundaria
Percent Change from Baseline in Total Cholesterol
Plazo Baseline and Week 72
Variable de resultado secundaria
Time to Onset of Type 2 Diabetes Mellitus (T2DM) in Participants with Prediabetes
Plazo Up to approximately 35 months
Variable de resultado secundaria
Time to the First HF Event
Plazo Up to approximately 35 months
Variable de resultado secundaria
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.
Plazo Up to approximately 35 months
Variable de resultado secundaria
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.
Plazo Baseline and Week 48
Variable de resultado secundaria
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.
Plazo Baseline and Week 48
Variable de resultado secundaria
Total Number of HF Events Including First and Recurrent HF Events
Plazo Up to approximately 35 months
Variable de resultado secundaria
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
Plazo Up to approximately 35 months
Variable de resultado secundaria
Change in eGFR Slope (Total)
Plazo Baseline up to approximately 35 months
Variable de resultado secundaria
Change in eGFR Slope (Chronic)
Plazo From 4 months up to approximately 35 months
Variable de resultado secundaria
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.
Plazo Baseline and Week 48
Variable de resultado secundaria
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.
Plazo Baseline and Week 48
Variable de resultado secundaria
Time to All-cause Death
Plazo Up to approximately 35 months
Variable de resultado secundaria
Time to CV Death
Plazo Up to Approximately 35 Months
Variable de resultado secundaria
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Plazo Up to approximately 35 months
Variable de resultado secundaria
Plasma Concentration of Maridebart Cafraglutide
Plazo Week 72
Variable de resultado secundaria
Change from Baseline in N-terminal Pro B Type Natriuretic Peptide (NT-proBNP)
Plazo Baseline and Week 72
Variable de resultado secundaria
Time to New Onset of Atrial Fibrillation (AF) or Atrial Flutter (AFL) in Participants Without a History of AF or AFL at Baseline
Plazo Baseline and up to approximately 35 months
Variable de resultado secundaria
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.
Plazo Up to approximately 35 months

Fechas

Fechas
Fecha de inicio	25 de junio de 2025 (real)
Finalización principal	30 de junio de 2028 (estimada)
Finalización	29 de septiembre de 2030 (estimada)
Primera publicación	25 de junio de 2025 (real)
Última actualización	16 de septiembre de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	septiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

637 centros están en reclutamiento

Argentina

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

Australia

Australia
Centro	Ciudad	Estado o región	Estado
Advara HeartCare Wesley	Auchenflower	Queensland	Finalizado antes de tiempo
Flinders Medical Centre	Bedford Park	South Australia	En reclutamiento
Sunshine Coast University Hospital	Birtinya	Queensland	En reclutamiento
Victorian Heart Hospital	Clayton	Victoria	En reclutamiento
Canberra Hospital	Garran	Australian Capital Territory	En reclutamiento
Royal Brisbane and Womens Hospital	Herston	Queensland	En reclutamiento
Advara HeartCare Joondalup	Joondalup	Western Australia	En reclutamiento
Advara HeartCare Leabrook	Leabrook	South Australia	En reclutamiento
Sydney Cardiometabolic Centre	Liverpool	New South Wales	En reclutamiento
The Alfred Hospital	Melbourne	Victoria	En reclutamiento
Core Research Group Pty Ltd	Milton	Queensland	En reclutamiento
Advara HeartCare Mulgrave	Mulgrave	Victoria	En reclutamiento
Fiona Stanley Hospital	Murdoch	Western Australia	En reclutamiento
Gold Coast Hospital and Health Service	Southport	Queensland	Finalizado antes de tiempo
Royal North Shore Hospital	St Leonards	New South Wales	En reclutamiento
Dr Heart Pty Ltd	Woolloongabba	Queensland	Finalizado antes de tiempo

Austria

Austria
Centro	Ciudad	Estado
Krankenhaus Sankt Josef Braunau	Braunau am Inn	En reclutamiento
Pro Kompetenzzentrum fuer Gesundheit	Graz	En reclutamiento
Medizinische Universitaet Graz	Graz	En reclutamiento
Klinikum Klagenfurt am Woerthersee	Klagenfurt	En reclutamiento
Ordensklinikum Linz Elisabethinen	Linz	En reclutamiento
Landeskrankenhaus Salzburg	Salzburg	En reclutamiento
Imed Sankt Poelten	Sankt Pölten	En reclutamiento
Universitaetsklinikum Sankt Poelten	Sankt Pölten	Finalizado antes de tiempo
Universitaetsklinikum Allgemeines Krankenhaus Wien	Vienna	En reclutamiento
Herz Zentrum Waehring	Vienna	En reclutamiento
Ordinationszentrum imedneunzehn privat	Vienna	En reclutamiento

En el registro figuran 607 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

16 de septiembre de 2026
Centro añadido
29 sites added (657 total)
628657

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

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