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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (23 UK sites)
University Hospital Monklands
Airdrie ML6 0JS, United Kingdom
North Tyneside General Hospital
Ashington NE63 9JJ, United Kingdom
Research and Development
researchanddevelopment@nhct.nhs.uk0191 2934087Ormeau Clinical Trials Ltd
Belfast BT2 8BG, United Kingdom
Royal Bournemouth Hospital
Bournemouth BH7 7DW, United Kingdom
Research Development & Support
clinicalresearch@bournemouth.ac.uk01202 961200Princess of Wales Hospital
Bridgend CF31 1RQ, United Kingdom
Southmead Hospital
Bristol BS10 5NB, United Kingdom
St Richards Hospital
Chichester PO19 6SE, United Kingdom
Ninewells Hospital and Medicine School
Dundee DD1 9SY, United Kingdom
Royal Devon and Exeter Hospital
Exeter EX2 5DW, United Kingdom
Glasgow Royal Infirmary
Glasgow G31 2ER, United Kingdom
Wycombe Hospital
High Wycombe HP11 2TT, United Kingdom
Highlands Clinical Research Facility, Raigmore Hospital
Inverness IV2 3UJ, United Kingdom
University Hospital Crosshouse
Kilmarnock KA2 0BE, United Kingdom
Glenfield Hospital
Leicester LE3 9QP, United Kingdom
University College London Hospital
London NW1 2BU, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825St Georges Hospital
London SW17 0QT, United Kingdom
Manchester Royal Infirmary
Manchester M13 9WL, United Kingdom
Newcastle NIHR Commercial Research Delivery Centre
Newcastle upon Tyne NE7 7DN, United Kingdom
Craigavon Area Hospital
Portadown, Craigavon BT63 5QQ, United Kingdom
Rachelle Moore
research.office@southerntrust.hscni.net028 3756 3755 Extension: 63755University Hospital of North Tees
Stockton-on-Tees TS19 8PE, United Kingdom
Research and Development
nth-tr.ntandh.researchdevelopment@nhs.net01642 624090Breckland Alliance Research
Thetford IP24 1JD, United Kingdom
Pinderfields Hospital
Wakefield WF1 4DG, United Kingdom
Marine Lake & Estuary Medical Practice
West Kirby CH48 5AA, United Kingdom
How to Get in Touch
Amgen Call Center
Sponsor contactCONTACT
