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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Kurz gefasst

Phase 35.056 Teilnehmende gesucht657 Studienzentren34 Länder

Kategorien

Herz-Kreislauf72%Endokrin und metabolisch28%

In 1 Register registriert

ClinicalTrials.govNCT07037459Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 5 Tagen

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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.

Zusammenfassung

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.

Erkrankungen

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

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – 99 Years
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	DOUBLE (2)
Teilnahme	5.056 Teilnehmende gesucht

Sponsor und Mitwirkende

Amgen Sponsor

Studienarme und Interventionen

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

Interventionen

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

Endpunkte

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

Daten

Daten
Startdatum	25. Juni 2025 (tatsächlich)
Primärer Abschluss	30. Juni 2028 (geschätzt)
Abschluss	29. September 2030 (geschätzt)
Erstveröffentlichung	25. Juni 2025 (tatsächlich)
Zuletzt aktualisiert	16. September 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	September 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

637 Studienzentren rekrutieren

Argentina

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

Australia

Australia
Einrichtung	Stadt	Bundesland oder Region	Status
Advara HeartCare Wesley	Auchenflower	Queensland	Vorzeitig beendet
Flinders Medical Centre	Bedford Park	South Australia	Rekrutiert
Sunshine Coast University Hospital	Birtinya	Queensland	Rekrutiert
Victorian Heart Hospital	Clayton	Victoria	Rekrutiert
Canberra Hospital	Garran	Australian Capital Territory	Rekrutiert
Royal Brisbane and Womens Hospital	Herston	Queensland	Rekrutiert
Advara HeartCare Joondalup	Joondalup	Western Australia	Rekrutiert
Advara HeartCare Leabrook	Leabrook	South Australia	Rekrutiert
Sydney Cardiometabolic Centre	Liverpool	New South Wales	Rekrutiert
The Alfred Hospital	Melbourne	Victoria	Rekrutiert
Core Research Group Pty Ltd	Milton	Queensland	Rekrutiert
Advara HeartCare Mulgrave	Mulgrave	Victoria	Rekrutiert
Fiona Stanley Hospital	Murdoch	Western Australia	Rekrutiert
Gold Coast Hospital and Health Service	Southport	Queensland	Vorzeitig beendet
Royal North Shore Hospital	St Leonards	New South Wales	Rekrutiert
Dr Heart Pty Ltd	Woolloongabba	Queensland	Vorzeitig beendet

Austria

Austria
Einrichtung	Stadt	Status
Krankenhaus Sankt Josef Braunau	Braunau am Inn	Rekrutiert
Pro Kompetenzzentrum fuer Gesundheit	Graz	Rekrutiert
Medizinische Universitaet Graz	Graz	Rekrutiert
Klinikum Klagenfurt am Woerthersee	Klagenfurt	Rekrutiert
Ordensklinikum Linz Elisabethinen	Linz	Rekrutiert
Landeskrankenhaus Salzburg	Salzburg	Rekrutiert
Imed Sankt Poelten	Sankt Pölten	Rekrutiert
Universitaetsklinikum Sankt Poelten	Sankt Pölten	Vorzeitig beendet
Universitaetsklinikum Allgemeines Krankenhaus Wien	Vienna	Rekrutiert
Herz Zentrum Waehring	Vienna	Rekrutiert
Ordinationszentrum imedneunzehn privat	Vienna	Rekrutiert

607 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

16. September 2026
Studienzentrum hinzugefügt
29 sites added (657 total)
628657

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