> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-research-study-to-look-at-how-well-zenagamtide-works-618cedf6-195c-4552-9300-a1328f07b026 > Record changed: 2026-11-04 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) Participants 8,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) Lead sponsor Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) Start date 2026-10-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) Number of sites 769 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Acronym** AMBIENCE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Official title** Zenagamtide Use for the Reduction of Risk of Major Adverse Cardiovascular Events in People With Established Atherosclerotic Cardiovascular Disease and Either Overweight or Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) ## Dates **Completion date** 2030-09-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **First posted** 2026-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Registry last updated** 2026-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Primary completion date** 2030-09-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Start date** 2026-10-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) ## Size and sites **Participants** 8,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Planned participants** 8,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Number of sites** 769 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Lead sponsor** Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) ## Identifiers **Registry ID** NCT07861100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **ClinicalTrials.gov ID** NCT07861100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Sponsor staff involved in the clinical trial is masked according to company standard procedures. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) ## Outcomes ### Primary outcomes 1. 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 Timeframe: From baseline (week 0) to up to 203 weeks or longer Measured in days. ### Secondary outcomes 1. 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 Timeframe: From baseline (week 0) to up to 203 weeks or longer Measured in days. 2. Time from randomization to first occurrence of a 3-P composite MACE endpoint consisting of: CV death, Non-fatal MI, Non-fatal stroke Timeframe: From baseline (week 0) to up to 203 weeks or longer Measured in days. 3. 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) Timeframe: From baseline (week 0) to week 104 Measured as mL/min/1.73 m\\^2. 4. Time from randomization to all-cause death Timeframe: From baseline (week 0) to up to 203 weeks or longer Measured in days. 5. Time from randomization to CV death Timeframe: From baseline (week 0) to up to 203 weeks or longer Measured in days. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 45 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) ## Sites - Uni of Alabama at BirminghamBirmingham, United States - Eastern Shore Rsrch Inst, LLCFairhope, United States - Mobile Heart SpecialistsMobile, United States - Chambliss Clinical Trials LLCMontgomery, United States - Mercy Gilbert Medical CenterGilbert, United States - Sun City Clinical ResearchGlendale, United States - Honor HealthScottsdale, United States - Clinical Research Institute of ArizonaSurprise, United States - National Heart Institute CalBeverly Hills, United States - California Inst Of Renal ResChula Vista, United States - Valley Clinical TrialsCovina, United States - First Valley Medical GroupLancaster, United States - Torrance Clin Res Inst, Inc.Lomita, United States - Pacific Clinical StudiesLos Alamitos, United States - Academic Medical Research InstituteLos Angeles, United States - Valley Clinical Trials, Inc.Northridge, United States - Desert Oasis Hlthcr Med GroupPalm Springs, United States - Clinical Trials Research\_SacramentoSacramento, United States - Paradigm Clinical ResearchSan Diego, United States - N America Res Inst - San DimasSan Dimas, United States - Fomat Medical ResearchSanta Maria, United States - Bridgeport HospitalBridgeport, United States - Innovative Research of W FLClearwater, United States - Nature Coast Clin Rsrch\_Crystal RiverCrystal River, United States - Florida Premier CardiologyDelray Beach, United States And 744 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) ## References ### Other registry identifiers (2) - 2026-525182-53 - U1111-1335-0048 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07861100) ## Related records ### Drugs (1) - [Zenagamtide](https://trialight.com/data/asset/zenagamtide-1657e00d-b72c-5541-9936-13b091a52ddc.md) ### Lead sponsors (1) - [Novo Nordisk A/S](https://trialight.com/data/company/novo-nordisk-a-s-35a80f1a-9ef6-4057-99c1-6ab497939195.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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