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 : Importé depuis le centre
RECRUTEMENT
Profil des participants
Limites d'âge
minimum : 45 ans
Sexe(s) des participants
ALL
Source : Importé depuis le centre
Condition médicale (spécialité visée)
Domaine de recherche
Donnée non disponible
Critères de sélection
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Zenagamtide
Participants will receive zenagamtide subcutaneously (s.c.) in a dose escalating manner once weekly.
Donnée non disponible
Inconnu
Placebo
Participants will receive placebo matched to zenagamtide s.c. once weekly.
Donnée non disponible
Inconnu
Zenagamtide
État du recrutement
unknown
Participants will receive zenagamtide subcutaneously (s.c.) in a dose escalating manner once weekly.
Placebo
État du recrutement
unknown
Participants will receive placebo matched to zenagamtide s.c. once weekly.
Données à jour depuis :
5 octobre 2026
SITES ET CONTACTS
Centre principal
uni of alabama at birmingham clinical research unit
BIRMINGHAM, ALABAMA, UNITED STATES
Recrutement local
—
À VENIR
Centres au Québec
Santé Québec – Centre hospitalier de l'Université de Montréal
MONTRÉAL, QUÉBEC, CANADA
Recrutement local
—
À VENIR
Santé Québec – Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
QUÉBEC, QUÉBEC, CANADA
Recrutement local
—
À VENIR
diex recherche sherbrooke est
SHERBROOKE, QUEBEC, CANADA
819-346-2887
Recrutement local
—
À VENIR
diex recherche joliette
JOLIETTE, QUEBEC, CANADA
579 841-0571
Recrutement local
—
À VENIR
diex recherche trois-rivières
TROIS-RIVIERES, QUEBEC, CANADA
819 801-9797
Recrutement local
—
À VENIR
ciuss hopit de chicoutimi
CHICOUTIMI, QUEBEC, CANADA
Recrutement local
—
À VENIR
chum-hosp de univ montreal
MONTREAL, QUEBEC, CANADA
Recrutement local
—
À VENIR
clinique de pneumologie et du sommeil de lanaudiere- cpsl ( site 0516)
ST-CHARLES-BORROMEE, QUEBEC, CANADA
Recrutement local
—
À VENIR
centricity research mirabel
MIRABEL, QUEBEC, CANADA
Recrutement local
—
À VENIR
centre de médecine métabolique de lanaudière
TERREBONNE, QUEBEC, CANADA
Recrutement local
—
À VENIR
chu de quebec-universite-laval,hdq
QUÉBEC, CANADA
Recrutement local
—
À VENIR
montreal heart institute, 5000 rue bélanger, montréal
MONTREAL, QUEBEC, CANADA
Recrutement local
—
À VENIR
ciusss de l'e chus_sherbrooke
SHERBROOKE, QUEBEC, CANADA
Recrutement local
—
À VENIR
Aussi disponible à: GILBERT, (ARIZONA), SCOTTSDALE, (ARIZONA), NORTHRIDGE, (CALIFORNIA), BOISE, (IDAHO), VENTURA, (CALIFORNIA), BRIDGEPORT, (CONNECTICUT), HOLLYWOOD, (FLORIDA), NASHVILLE, (TENNESSEE), NANTUCKET, (MASSACHUSETTS), CUMMING, (GEORGIA), BOSSIER CITY, (LOUISIANA), ...
et 745 autres villes.
Dernière modification :
5 octobre 2026
Données à jour depuis :
8 oct.
Origine des données :
clinicaltrials.gov
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
* 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.
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Zenagamtide
Participants will receive zenagamtide subcutaneously (s.c.) in a dose escalating manner once weekly.
Donnée non disponible
Inconnu
Placebo
Participants will receive placebo matched to zenagamtide s.c. once weekly.
Donnée non disponible
Inconnu
Zenagamtide
État du recrutement
unknown
Participants will receive zenagamtide subcutaneously (s.c.) in a dose escalating manner once weekly.
Placebo
État du recrutement
unknown
Participants will receive placebo matched to zenagamtide s.c. once weekly.
Données à jour depuis :
5 octobre 2026
Description de l'étude
Description de l'étude
Résumé de l'étude
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 : Importé depuis le centre
Centres participants
Sites
Centres participants
10
affichés
sur
757
centres
"AHEPA" UNIVERSITY GENERAL HOSPITAL OF THESSALONIKI
Thessaloniki
GREECE
Recrutement local
État du recrutement:
À VENIR
"HYGEIA" GENERAL HOSPITAL OF ATHENS
Athens
GREECE
Recrutement local
État du recrutement:
À VENIR
'G. GENNIMATAS' GENERAL HOSPITAL OF ATHENS - CARDIOLOGY DEPARTMENT
Athens
GREECE
Recrutement local
État du recrutement:
À VENIR
'IPPOKRATEIO' GENERAL HOSPITAL OF THESSALONIKI
Thessaloniki
GREECE
Recrutement local
État du recrutement:
À VENIR
(SITE 106) COLCHESTER RESEARCH GROUP
Truro
NOVA SCOTIA, CANADA
Recrutement local
État du recrutement:
À VENIR
(SITE 417) MEDIZENTRUM ESSEN-BORBECK
Essen
GERMANY
Recrutement local
État du recrutement:
À VENIR
6160096 - 1 WOJSKOWY SZPITAL KLINICZNY Z POLIKLINIKA SPZOZ W LUBLINIE
Lublin
LUBLIN VOIVODESHIP, POLAND
Recrutement local
État du recrutement:
À VENIR
71006-DJW RESEARCH
Krugersdorp
GAUTENG, SOUTH AFRICA
Recrutement local
État du recrutement:
À VENIR
8400805 - PHARMATEX RESEARCH
Amarillo
TEXAS, UNITED STATES
Recrutement local
État du recrutement:
À VENIR
934 SECOND DEPT OF INTERNAL DISEASE, MHAT SVETA KARIDAD EAD
Plovdiv
BULGARIA
Recrutement local
État du recrutement:
À VENIR
Centres participants
Source d'information
Dernière modification :
5 octobre 2026
Données à jour depuis :
8 oct.
Origine des données :
clinicaltrials.gov