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.
Plain-language title generated from the registry record
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
Key facts
- Where
- Acquaviva delle Fonti, Bari, Bergamo, Castellana Grotte, Catanzaro, Chieti Scalo, Cosenza, Ferrara, Florence, Grosseto, Latina, Lucca, Milan, Naples, Negrar, Orbassano, Padova, Rimini, Rome, Salerno, Sesto San Giovanni, Siena, Turin, and Venice, ItalySee the 31 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT07861100, who can take part
Where in Italy
- Ente Ecclesiastico ospedale generale Regionale MiulliAcquaviva delle Fonti, ItalyTaking people
- Azienda Universitaria Ospedaliera Consorziale Policlinico BariBari, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- National Institute of Gastroenterology Saverio De Bellis Research HospitalCastellana Grotte, ItalyTaking people
- Azienda Ospedaliero Universitaria Renato DulbeccoCatanzaro, ItalyTaking people
- Universita' Degli Studi G. D'Annunzio Di ChietiChieti Scalo, ItalyTaking people
- Azienda Ospedaliera-Universitaria Di CosenzaCosenza, ItalyTaking people
- University Hospital Of FerraraFerrara, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- Azienda Unita' Sanitaria Locale Toscana Sud EstGrosseto, ItalyTaking people
- Casa Di Cura Accreditata Istituto Chirurgico Ortopedico Traumatologico Marco PasqualiLatina, ItalyTaking people
- Ospedale Santa Maria Goretti LatinaLatina, ItalyTaking people
- Azienda Unita' Sanitaria Locale Toscana Nord OvestLucca, ItalyTaking people
- ASST Fatebenefratelli SaccoMilan, ItalyTaking people
- Centro Cardiologico Monzino S.p.A.Milan, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Azienda Ospedaliera dei ColliNaples, ItalyTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
- IRCCS Ospedale Sacro Cuore Don CalabriaNegrar, ItalyTaking people
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyTaking people
- Azienda Ospedaliera di PadovaPadova, ItalyTaking people
- Azienda Unita Sanitaria Locale Della RomagnaRimini, ItalyTaking people
- Azienda Ospedaliera S Giovanni AddolorataRome, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Azienda Ospedaliero-Universitaria Sant AndreRome, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'AragonaSalerno, ItalyTaking people
- Multimedica S.p.A.Sesto San Giovanni, ItalyTaking people
- Azienda Ospedaliero Universitaria SeneseSiena, ItalyTaking people
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, ItalyTaking people
- Azienda Ulss 3 SerenissimaVenice, ItalyTaking people
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?
Trial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- NCT07861100EU 2026-525182-53-00
- Record updated
- 6 October 2026
- Original description
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.Read full original descriptionShow less
Zenagamtide Use for the Reduction of Risk of Major Adverse Cardiovascular Events in People With Established Atherosclerotic Cardiovascular Disease and Either Overweight or Obesity
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.
Inclusion: 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.
Exclusion: 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.