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.
Treatment should be stable for greater than or equal to (≥) 90 days before screening as assessed by the investigator.
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.
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.
Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
Parallel
Zenagamtide
DrugZenagamtide will be administered subcutaneously.
Placebo
DrugPlacebo will be administered subcutaneously.
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
Measured in days.
Time from randomization to first occurrence of an expanded 5-P composite MACE endpoint consisting of: All-cause death, Non-fatal MI, Non-fatal stroke, HF hospitalization or urgent HF visit, Coronary revascularization
Measured in days.
Time from randomization to first occurrence of a 3-P composite MACE endpoint consisting of: CV death, Non-fatal MI, Non-fatal stroke
Measured in days.
Change in Estimated Glomerular Filtration Rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021) for participants with baseline eGFR< 60 millilitre per minute per 1.73 square metre (mL/min/1.73 m^2)
Measured as mL/min/1.73 m\^2.
Time from randomization to all-cause death
Measured in days.
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