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Clinical Trials in the UK / NCT07861100
Starting soon Phase 3

A Research Study to Look at How Well Zenagamtide Works Compared to Placebo in People With Established Atherosclerotic Cardiovascular Disease and Either Overweight or Obesity

NCT07861100 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2026-10-26
Last updated
2026-10-06

Condition(s) studied

Cardiovascular RiskObesity

Investigational drug(s) / intervention(s)

Zenagamtide →Placebo

Zenagamtide: Zenagamtide will be administered subcutaneously.

Placebo: Placebo will be administered subcutaneously.

Study summary

This clinical study is being conducted to evaluate the safety and effectiveness of zenagamtide in people with atherosclerotic cardiovascular disease (ASCVD) and excess body weight compared with placebo. The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have ASCVD and excess body weight. Participants will be randomly assigned by chance to receive either zenagamtide, the investigational treatment being tested, or a placebo, which contains no active medicine. Half of the participants will receive zenagamtide, and treatment assignment will be determined randomly. Zenagamtide is a new investigational medicine that is not yet available for prescription by doctors.

Eligibility

Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Established ASCVD is defined as at least one of the below conditions (a-c): a. Prior myocardial infarction (MI) b. Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an ankle-brachial index (ABI) less than (\<) 0.85 at rest ii. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis) c. Cerebrovascular disease defined as the following: i. Prior stroke * Participants with Type 2 Diabetes (T2D) (at screening) are allowed in the study with the following provisions: 1. Treatment should be stable for greater than or equal to (≥) 90 days before screening as assessed by the investigator. 2. Glucose lowering agents are permitted according to local label except glucagon-like peptide-1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) and amylin analogues; for insulins, only basal insulin is allowed. Exclusion Criteria: * MI, stroke, unstable angina pectoris, or worsening heart failure (HF) leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization. * Coronary, carotid, or peripheral artery revascularization or percutaneous valve repair or replacement within 30 days prior to the day of screening or planned during the study period and known at screening. * Chronic heart failure classified at screening. * Glycaemia-related: 1. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator. 2. Known history of hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8. 3. History of type 1 diabetes (T1D). 4. Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. 5. Glycated haemoglobin (HbA1c) greater than (\>) 10 percentage (%) (86 millimoles per mole \[mmol/mol\]) as measured by central laboratory at screening. * General health and safety: 1. Treatment with any GLP-1 RA, GIP RA or amylin analogue for any indication before screening.

Primary outcome measure(s)

Trial sites (769)

FacilityCityRegionStatus
Uni of Alabama at Birmingham Birmingham Alabama
Eastern Shore Rsrch Inst, LLC Fairhope Alabama
Mobile Heart Specialists Mobile Alabama
Chambliss Clinical Trials LLC Montgomery Alabama
Mercy Gilbert Medical Center Gilbert Arizona
Sun City Clinical Research Glendale Arizona
Honor Health Scottsdale Arizona
Clinical Research Institute of Arizona Surprise Arizona
National Heart Institute Cal Beverly Hills California
California Inst Of Renal Res Chula Vista California
Valley Clinical Trials Covina California
First Valley Medical Group Lancaster California
Torrance Clin Res Inst, Inc. Lomita California
Pacific Clinical Studies Los Alamitos California
Academic Medical Research Institute Los Angeles California
Valley Clinical Trials, Inc. Northridge California
Desert Oasis Hlthcr Med Group Palm Springs California
Clinical Trials Research_Sacramento Sacramento California
Paradigm Clinical Research San Diego California
N America Res Inst - San Dimas San Dimas California
Fomat Medical Research Santa Maria California
Bridgeport Hospital Bridgeport Connecticut
Innovative Research of W FL Clearwater Florida
Nature Coast Clin Rsrch_Crystal River Crystal River Florida
Florida Premier Cardiology Delray Beach Florida
Encore Medical Research LLC Hollywood Florida
Est Cst Inst for Rsrch,Jksnvil Jacksonville Florida
Jacksonville Ctr Clin Res Jacksonville Florida
Clinical Research of Cent FL Lakeland Florida
K2 Medical Research Maitland Florida
Life Spring Research Foundation LLC Miami Florida
Flourish Research - North Miami Miami Florida
Oceane 7 Medical & Research Center, Inc. Miami Florida
San Marcus Res Clin Miami Lakes Miami Lakes Florida
Advance Rsch for Hlth Improvement_Naples Naples Florida
Suncoast Clinical Research, Inc. New Port Richey Florida
Ocala Cardiovascular Research Ocala Florida
Oviedo Medical Research, LLC Oviedo Florida
Cardio Partners Clin Res Inst Palm Beach Gardens Florida
Suncoast Clinical Research, Inc. Palm Harbor Florida

+ 729 more sites — see the full list on the official registry below.

More Novo Nordisk A/S trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07861100 on ClinicalTrials.gov ↗ ← All trials in the UK