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
- A Coruña, Barcelona, Boadilla del Monte, Cáceres, Córdoba, Granada, Huelva, Lleida, Madrid, Majadahonda, Málaga, Marbella, Murcia, Oviedo, Pamplona, Santander, Sevilla, Valencia, Valladolid, and Vigo, SpainSee the 27 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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
Read by machine on 12 November 2026.
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 Spain
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpainTaking people
- Hospital del MarBarcelona, SpainTaking people
- Hospital Quirónsalud BarcelonaBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario HM MonteprincipeBoadilla del Monte, SpainTaking people
- Hospital San Pedro De AlcántaraCáceres, SpainTaking people
- Hospital Universitario Reina SofiaCórdoba, SpainTaking people
- Hospital Universitario Virgen de las NievesGranada, SpainTaking people
- Hospital Universitario Juan Ramon JimenezHuelva, SpainTaking people
- Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De LleidaLleida, SpainTaking people
- Hospital Clínico San CarlosMadrid, SpainTaking people
- Hospital La Luz Grupo QuironsaludMadrid, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainTaking people
- Hospital Universitario Infanta LeonorMadrid, SpainTaking people
- Hospital Universitario La PazMadrid, SpainTaking people
- Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpainTaking people
- Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
- Hospital Costa del SolMarbella, SpainTaking people
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpainTaking people
- Hospital Universitario Central De AsturiasOviedo, SpainTaking people
- Hospital Universitario de NavarraPamplona, SpainTaking people
- Hospital Universitario Marqués de ValdecillaSantander, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
- Consorcio Hospital General Universitario de ValenciaValencia, SpainTaking people
- Hospital Universitario Rio HortegaValladolid, SpainTaking people
- Hospital Alvaro CunqueiroVigo, SpainTaking 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.