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
- Bialystok, Białystok, Bielsko-Biala, Bydgoszcz, Chrzanów, Cracow, Czestochowa, Dąbrowa Górnicza, Gdansk, Gdynia, Gliwice, Gorzów Wielkopolski, Grodzisk Mazowiecki, Katowice, Kędzierzyn-Koźle, Kluczbork, Krakow, Krosno, Ksawerów, Lodz, Lubin, Lublin, Ostrów Mazowiecka, Ostrów Wielkopolski, Oswiecim, Piotrkow Trybunalski, Poznan, Raciborz, Rzeszow, Skierniewice, Torun, Warsaw, Zamość, Żarów, and Zgierz, PolandSee the 59 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 Poland
- Kresmed Sp. z o. o.Bialystok, PolandTaking people
- Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, PolandTaking people
- angiolog.pl PIOTR LISOWSKIBiałystok, PolandTaking people
- American Heart of Poland S.A.Bielsko-Biala, PolandTaking people
- Centrum Medyczne "Hipokrates" s.c. Elżbieta i Grzegorz GrześkBydgoszcz, PolandTaking people
- American Heart of Poland S.A.Chrzanów, PolandTaking people
- Centrum Medyczne Zdrowa J. Trebacz W. Zajdel Sp. j.Cracow, PolandTaking people
- Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.Cracow, PolandTaking people
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracow, PolandTaking people
- Scanmed S.A.Cracow, PolandTaking people
- Szpital Specjalistyczny Im.J.Dietla W KrakowieCracow, PolandTaking people
- Unicardia Specjalistyczne Centrum Leczenia Chorob Serca I Naczyn & Unimedica Specjalistyczne Centrum Medyczne & Uniestetica Centrum Chirurgii Plastycznej Rekonstrukcyjnej I Medycyny Estetycznej Malopolskie Kliniki Specjalistyczne Sp. z o.o.Cracow, PolandTaking people
- Synexus Polska Sp. z o.o.Czestochowa, PolandTaking people
- American Heart of Poland S.A.Dąbrowa Górnicza, PolandTaking people
- Synexus Polska Sp z o.o.Gdansk, PolandTaking people
- Pratia S.A.Gdynia, PolandTaking people
- Synexus Polska Sp. z o.o.Gdynia, PolandTaking people
- Uniwersyteckie Centrum Medycyny Morskiej i TropikalnejGdynia, PolandTaking people
- Szpital Miejski w Gliwicach Sp. z o.o.Gliwice, PolandTaking people
- Specjalistyczny Gabinet Diabetologiczny Radosław RumianowskiGorzów Wielkopolski, PolandTaking people
- Ameds Clinical Research Sp. z o.o.Grodzisk Mazowiecki, PolandTaking people
- Care Clinic Sp. Z O.O.Katowice, PolandTaking people
- Clinical Medical Research Sp. z o.o.Katowice, PolandTaking people
- Gyncentrum Sp. z o.o.Katowice, PolandTaking people
- Vita Longa Sp. Z o.o.Katowice, PolandTaking people
- American Heart of Poland S.A.Kędzierzyn-Koźle, PolandTaking people
- Scanmed S.A.Kluczbork, PolandTaking people
- Specjalistyczna Praktyka Lekarska Ewa Mirek-BryniarskaKrakow, PolandTaking people
- Intercard Sp. z o.o.Krosno, PolandTaking people
- Centrum Opieki Zdrowotnej Orkan-Med Stec - Michalska Sp. j.Ksawerów, PolandTaking people
- Synexus Polska Sp. z o.o.Lodz, PolandTaking people
- Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZLodz, PolandTaking people
- Wojewodzki Specjalistyczny Szpital Im Dr Wl BieganskiegoLodz, PolandTaking people
- Miedziowe Centrum Zdrowia S.ALubin, PolandTaking people
- 1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w LublinieLublin, PolandTaking people
- Clinical Best Solutions Sp. z o.o. S.K.Lublin, PolandTaking people
- Drelich Grzegorz Centrum Kardiologiczne Kardio-MedLublin, PolandTaking people
- Niepubliczny Zaklad Opieki Zdrowotnej Twoja Przychodnia Sp. z o.o.Lublin, PolandTaking people
- Zana-Med Medical Group Sp. z o.o.Lublin, PolandTaking people
- Kresmed Sp. z o. o.Ostrów Mazowiecka, PolandTaking people
- Jantar Sp. z o.o.Ostrów Wielkopolski, PolandTaking people
- Formed 2 Sp. z o.o.Oswiecim, PolandTaking people
- Provita Centrum Medyczne Sp. z o.o.Piotrkow Trybunalski, PolandTaking people
- Synexus Polska Sp z o oPoznan, PolandTaking people
- Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, PolandTaking people
- Scanmed S.A.Raciborz, PolandTaking people
- Ministerstwa Spraw Wewnetrznych I Administracji W Rzeszowie SPZOZRzeszow, PolandTaking people
- Velocity Nova Sp. z o.o.Skierniewice, PolandTaking people
- Gabinety od serca Bębenek,Mazurek,Metzgier-Gumiela sp. j.Torun, PolandTaking people
- Balsammedica Sp. z o. o.Warsaw, PolandTaking people
- Centrum medyczne Justmed Sp. z o.o.Warsaw, PolandTaking people
- Etg Warszawa Sp. z o.o.Warsaw, PolandTaking people
- Gyncentrum Sp. z o. o.Warsaw, PolandTaking people
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory ReicherWarsaw, PolandTaking people
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut BadawczyWarsaw, PolandTaking people
- Nbr Polska Tomasz KlodawskiWarsaw, PolandTaking people
- Etg Zamosc Sp. z o.o.Zamość, PolandTaking people
- NZOZ Centrum Medyczne SERAFIN-MED Halina SerafinŻarów, PolandTaking people
- American Heart of Poland S.A.Zgierz, PolandTaking 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.