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Looking for participantsPhase3

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

Sponsor: Amgen

NCT ID: NCT07037459

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Maridebart cafraglutide (drug), Placebo (drug)
How long the study runs
Study runs about 63 months (dates as stated)
About the drug or intervention
Maridebart cafraglutide — drug: Maridebart cafraglutide will be administered SC. · Placebo — drug: Placebo will be administered SC.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 99 Years
Who
All
Number of participants
5,056
Started
2025-06-25
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure with preserved ejection fraction
  • • Phase3 - 5,056 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 99 Years
  • • Diagnosed with heart failure with preserved ejection fraction

Where?

  • • Airdrie - University Hospital Monklands
  • • Ashington - North Tyneside General Hospital
  • • Belfast - Ormeau Clinical Trials Ltd
  • • Bournemouth - Royal Bournemouth Hospital
  • • +19 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Heart Failure With Preserved Ejection FractionHeart Failure With Mildly Reduced Ejection FractionObesity

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 99 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Age ≥ 18 years at the time of agreement to take part.
  • ✓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 agreement to take part.
  • ✓Managed with HF the usual treatment therapies.
  • ✓Left ventricular ejection fraction (LVEF) of \> 40% within 12 months before randomization.

Who cannot take part

  • ✗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):
  • ✗HbA1c \> 10.0% (86 mmol/mol) at screening
  • ✗Uncontrolled diabetes requiring immediate therapy
See the full criteria
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.

Where Is This Study? (23 UK sites)

University Hospital Monklands

Airdrie ML6 0JS, United Kingdom

Recruiting

North Tyneside General Hospital

Ashington NE63 9JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

researchanddevelopment@nhct.nhs.uk0191 2934087

Ormeau Clinical Trials Ltd

Belfast BT2 8BG, United Kingdom

Recruiting

Royal Bournemouth Hospital

Bournemouth BH7 7DW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research Development & Support

clinicalresearch@bournemouth.ac.uk01202 961200

Princess of Wales Hospital

Bridgend CF31 1RQ, United Kingdom

Recruiting

Southmead Hospital

Bristol BS10 5NB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

St Richards Hospital

Chichester PO19 6SE, United Kingdom

Recruiting

Ninewells Hospital and Medicine School

Dundee DD1 9SY, United Kingdom

Recruiting

Royal Devon and Exeter Hospital

Exeter EX2 5DW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

Glasgow Royal Infirmary

Glasgow G31 2ER, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

Wycombe Hospital

High Wycombe HP11 2TT, United Kingdom

Recruiting

Highlands Clinical Research Facility, Raigmore Hospital

Inverness IV2 3UJ, United Kingdom

Recruiting

University Hospital Crosshouse

Kilmarnock KA2 0BE, United Kingdom

Recruiting

Glenfield Hospital

Leicester LE3 9QP, United Kingdom

Recruiting

University College London Hospital

London NW1 2BU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

St Georges Hospital

London SW17 0QT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mr Subhir Bedi

researchgovernance@sgul.ac.uk020 8725 4986

Manchester Royal Infirmary

Manchester M13 9WL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

Newcastle NIHR Commercial Research Delivery Centre

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting

Craigavon Area Hospital

Portadown, Craigavon BT63 5QQ, United Kingdom

Recruiting

University Hospital of North Tees

Stockton-on-Tees TS19 8PE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

nth-tr.ntandh.researchdevelopment@nhs.net01642 624090

Breckland Alliance Research

Thetford IP24 1JD, United Kingdom

Recruiting

Pinderfields Hospital

Wakefield WF1 4DG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Judith Holliday

Midyorks.My.Research@nhs.net01924 543772

Marine Lake & Estuary Medical Practice

West Kirby CH48 5AA, United Kingdom

Recruiting

How to Get in Touch

Amgen Call Center

Sponsor contact

CONTACT

866-572-6436 medinfo@amgen.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09