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Looking for participantsPhase3

Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity

Sponsor: Amgen

NCT ID: NCT07037433

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 62 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
45 Years to 99 Years
Who
All
Number of participants
12,800
Started
2025-07-25
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for atherosclerotic cardiovascular disease
  • • Phase3 - 12,800 participants
  • • The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality

Who can take part?

  • • Ages 45 Years to 99 Years
  • • Diagnosed with atherosclerotic cardiovascular disease

Where?

  • • Birmingham - Heartlands Hospital
  • • Blackpool - Waterloo Medical Centre
  • • Bristol - Southmead Hospital
  • • Bristol - West Walk Surgery
  • • +24 more UK sites

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

About This Trial

The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.

Atherosclerotic Cardiovascular DiseaseOverweightObesity

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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: 45 Years - 99 Years
  • Who can join: All genders

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Age ≥ 45 years at screening.
  • ✓BMI of ≥ 27.0 kg/m\^2 at screening.
  • ✓History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following:
  • ✓Prior MI (presumed atherothrombotic event due to plaque rupture/erosion).
See the full criteria
Inclusion Criteria * Age ≥ 45 years at screening. * BMI of ≥ 27.0 kg/m\^2 at screening. * History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following: * Prior MI (presumed atherothrombotic event due to plaque rupture/erosion). * Prior ischemic stroke (presumed due to atherosclerosis; may include ischemic stroke with hemorrhagic transformation). * Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) \< 0.9 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease. Exclusion Criteria * History of any of the following within 60 days before screening or between screening and randomization: MI, hospitalization for unstable angina, arterial revascularization (eg, coronary, cerebrovascular or peripheral) major cardiovascular surgery, stroke, or transient ischemic attack (TIA). * New York Heart Association (NYHA) class IV HF during screening or hospitalization for HF within 60 days before screening or between screening and randomization. * Type 1 DM, or any other type of diabetes with the exception of T2DM or prior gestational diabetes. Participants with a history of gestational diabetes should be stratified according to their current diabetes classification. * For participants with T2DM (including those without a prior history of T2DM but with a HbA1c ≥ 6.5% during screening): * HbA1c \> 10.0% (86 mmol/mol) at screening. * History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization. * One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness. * History of proliferative diabetic retinopathy, diabetic maculopathy, severe non-proliferative diabetic retinopathy, or currently receiving or planning to receive treatment for diabetic retinopathy and/or diabetic macular edema. * 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 before randomization or planned use during the conduct of the trial. * History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening or between screening and randomization. * Family (first-degree relative\[s\]), or personal history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN-2). * Calcitonin ≥ 50 ng/L (pg/mL) at screening. * Acute or chronic hepatitis; signs and symptoms of any liver disease other than metabolic dysfunction-associated steatotic liver disease, or alanine aminotransferase (ALT) \> 3.0 x the upper limit of normal (ULN) during screening, or total bilirubin (TBL) \> 1.8 x ULN during screening (for participants with a known diagnosis of Gilbert syndrome, direct bilirubin should be used instead of TBL). * History of malignancy within the last 5 years before screening or between screening and randomization (except for the following treated with curative intent: non-melanoma skin cancer, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ). * Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment.

Where Is This Study? (28 UK sites)

Heartlands Hospital

Birmingham B9 5SS, United Kingdom

Recruiting

Waterloo Medical Centre

Blackpool FY4 3AD, 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

West Walk Surgery

Bristol BS37 4AX, United Kingdom

Recruiting

Addenbrookes Hospital

Cambridge CB2 0QQ, United Kingdom

TERMINATED
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Countess of Chester Hospital

Chester CH2 1UL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jude Prince

coch.rd-facilitator@nhs.net01244 365243

University Hospital Coventry

Coventry CV2 2DX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Josie Goodby

research@uhcw.nhs.uk02476 965244

Russell Hall Hospital

Dudley DY1 2HQ, United Kingdom

Recruiting

Ninewells Hospital and Medical School

Dundee DD1 9SY, United Kingdom

Recruiting

Staploe Medical Centre

Ely CB7 5JD, 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

Hull Royal Infirmary

Hull HU3 2JZ, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

Glenfield Hospital

Leicester LE3 9QP, United Kingdom

Recruiting

Queen Mary University of London

London EC1M 6BQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

Chelsea and Westminster Hospital

London SW10 9NH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Damon Foster

damon.foster2@nhs.net020 3316 6887

St Georges Hospital

London SW17 0QT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mr Subhir Bedi

researchgovernance@sgul.ac.uk020 8725 4986

Northenden Group Practice

Manchester M22 4DH, United Kingdom

TERMINATED

Newcastle NIHR Commercial Research Delivery Centre

Newcastle upon Tyne NE1 4LP, United Kingdom

Recruiting

University Hospital Llandough

Penarth CF64 2XX, United Kingdom

Recruiting

Salford Royal Hospital

Salford M5 5AP, United Kingdom

Recruiting

Lister Hospital

Stevenage SG1 4AB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)

mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069

Morriston Hospital

Swansea SA2 8PP, United Kingdom

Recruiting

Musgrove Park Hospital

Taunton TA1 5DA, United Kingdom

Recruiting

Torbay Hospital

Torquay TQ2 7AA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Fiona Roberts (R&D Director)

tsdft.research@nhs.net01803 656635

Bradford on Avon and Melksham Health Partnership

Wiltshire BA15 1DQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jane Dennison

bradfordresearch.applications@bthft.nhs.uk01274 382575

Worcestershire Royal Hospital

Worcester WR5 1DD, 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: 2026-10