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
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)
Time from randomization to first occurrence of a 4-point (P) composite major adverse cardiovascular events (MACE) endpoint consisting of: Cardiovascular (CV) death, Non-fatal MI, Non-fatal stroke, HF hospitalization or urgent HF visit — From baseline (week 0) to up to 203 weeks or longer Measured in days.
Trial sites (769)
Facility
City
Region
Status
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.
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.
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