Not yet taking people in BrazilPhase 3
Zenagamtide Compared With Placebo in People With Heart Disease and Excess Weight
Tests zenagamtide against placebo in people with atherosclerotic heart disease and excess weight.
Key facts
- Who runs it
- Novo Nordisk A/S
- Where
- Bairro Rodolfo Teófilo, Fortaleza, Botucatu, Bragança Paulista, Campinas, Curitiba, Goiânia, Manaus, Marília, Poços de Caldas, Porto Alegre, São José dos Campos, Sao Jose Rio Preto, and São Paulo, BrazilSee the 20 sitesAlso in 25 other countries, 741 sites
- Trial code
- NCT07861100
- EU 2026-525182-53-00
- U1111-1335-0048
- Registry 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
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 8,500 people, planned
- Started
- 26 Oct 2026
- Expected to end
- 16 Sept 2030
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Zenagamtide
- Placebo
- Record updated
- 6 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 45 to 64 who have established atherosclerotic cardiovascular disease and are overweight or obese. They will get zenagamtide or a placebo.
- Age
- 45 Years to 64 Years
- Sex
- All sexes can join.
- Disease stage
- Established atherosclerotic cardiovascular disease: a prior heart attack, symptomatic peripheral artery disease, or a prior stroke. Type 2 diabetes is allowed if treatment has been stable for at least 90 days.
- Earlier treatment
- People who ever took a GLP-1 RA, GIP RA or amylin analogue cannot join. Type 2 diabetes treatment must be stable for at least 90 days before screening, with only basal insulin allowed.
- Biomarker or test result
- HbA1c must not be above 10 % (86 mmol/mol) at screening.
Main reasons for not taking part
- Heart attack, stroke, unstable angina or worsening heart failure needing hospital or IV diuretics within 30 days before screening
- Artery revascularization or valve repair or replacement within 30 days before screening or planned during the study
- Chronic heart failure at screening
- History of type 1 diabetes
- Recurrent severe low blood sugar episodes in the last year, or hypoglycaemia unawareness
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Established ASCVD is defined as at least one of the below conditions (a-c):; 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:; 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
Who cannot take part
- 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
- General health and safety:; Treatment with any GLP-1 RA, GIP RA or amylin analogue for any indication before screening
- Chronic heart failure classified at screening
- Glycaemia-related:; Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator; Known history of hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8; History of type 1 diabetes (T1D); 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; Glycated haemoglobin (HbA1c) greater than (>) 10 percentage (%) (86 millimoles per mole [mmol/mol]) as measured by central laboratory at screening
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 64 years old?
Where in Brazil
Also in 25 other countries, 741 sites
- Hospital Universitário Walter CantídioBairro Rodolfo Teófilo, Fortaleza, BrazilContact: Novo NordiskNo longer taking part
- Universidade Estadual Paulista Julio de Mesquita Filho- Campus de Botucatu Faculdade de MedicinaBotucatu, BrazilContact: Novo NordiskNo longer taking part
- Associação Lar São Francisco de Assis na Providência de Deus - Bragança PaulistaBragança Paulista, BrazilContact: Novo NordiskNo longer taking part
- i9 Pesquisas ClínicasCampinas, BrazilContact: Novo NordiskNo longer taking part
- Instituto de Pesquisa Clínica de CampinasCampinas, BrazilContact: Novo NordiskNo longer taking part
- Sociedade Campineira De Educação E Instrução (SCEI)Campinas, BrazilContact: Novo NordiskNo longer taking part
- PUCPR - Pontificia Universidade Catolica do ParanaCuritiba, BrazilContact: Novo NordiskNo longer taking part
- Hospital Ruy Azeredo LtdaGoiânia, BrazilContact: Novo NordiskNo longer taking part
- CPHosp Manaus Medicina, Ensino e Pesquisa LTDAManaus, BrazilContact: Novo NordiskNo longer taking part
- Irmandade da Santa Casa de Misericordia de MariliaMarília, BrazilContact: Novo NordiskNo longer taking part
- Hospital Maternidade e Pronto Socorro Santa LuciaPoços de Caldas, BrazilContact: Novo NordiskNo longer taking part
- Hospital de Clinicas de Porto AlegrePorto Alegre, BrazilContact: Novo NordiskNo longer taking part
- Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.Porto Alegre, BrazilContact: Novo NordiskNo longer taking part
- CIPES - Centro Internacional de Pesquisa Clínica LTDASão José dos Campos, BrazilContact: Novo NordiskNo longer taking part
- Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio PretoSao Jose Rio Preto, BrazilContact: Novo NordiskNo longer taking part
- BR Trials - Ensaios Clínicos e Consultoria Ltda.São Paulo, BrazilContact: Novo NordiskNo longer taking part
- Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USPSão Paulo, BrazilContact: Novo NordiskNo longer taking part
- CPQuali Pesquisa Clínica LtdaSão Paulo, BrazilContact: Novo NordiskNo longer taking part
- Instituto Brasileiro de Controle do CânceNúcleo de Pesquisa e Ensino IBCC / São CamiloSão Paulo, BrazilContact: Novo NordiskNo longer taking part
- Instituto do Coração - HCFMUSPSão Paulo, BrazilContact: Novo NordiskNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- ZenagamtideTreatment being tested
Participants will receive zenagamtide subcutaneously (s.c.) in a dose escalating manner once weekly.
- PlaceboPlacebo, for comparison
Participants will receive placebo matched to zenagamtide s.c. once weekly.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- Zenagamtide Compared With Placebo in People With Heart Disease and Excess WeightGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07861100, who can take part
- Record updated
- 6 October 2026