Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and Major Adverse Kidney Events in Participants With Body Mass Index ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease
Interventional
Phase 3
Eli Lilly and Company (Voir sur ClinicalTrials)
avril 2024
février 2029
03 janvier 2025
The main purpose of this study is to determine if retatrutide can significantly lower the
incidence of serious heart-related complications or prevent the worsening of kidney
function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and
Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last
for about 5 years. Participants will have up to 27 clinic visits with the study doctor.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital La Pitié-Salpêtrière | Contact (sur clinicalTrials) | ||||
| CENTRE HOSPITALIER SUD FRANCILIEN | Contact (sur clinicalTrials) | ||||
| GH PARIS SITE SAINT JOSEPH | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Bordeaux University Hospital - Pellegrin - 33076 - Bordeaux - Aquitaine - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Louis Pasteur - 28630 - Le Coudray - Eure-et-Loir - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau - 37000 - Tours - Indre-et-Loire - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Nice - Hopital Pasteur - 06000 - Nice - Alpes-Maritimes - France | Contact (sur clinicalTrials) | ||||
| CHU Bordeaux Haut-Leveque - 33600 - Pessac - Aquitaine - France | Contact (sur clinicalTrials) | ||||
| Chu Gabriel Montpied - 63000 - Clermont-Ferrand - Puy-de-Dôme - France | Contact (sur clinicalTrials) | ||||
| Chu Grenoble Alpes - 38700 - La Tronche - Isère - France | Contact (sur clinicalTrials) | ||||
| CHU Montpellier Lapeyronie Hospital - 34295 - Montpellier - Hérault - France | Contact (sur clinicalTrials) | ||||
| CHU Rangueil - 31059 - Toulouse cedex 9 - Haute-Garonne - France | Contact (sur clinicalTrials) | ||||
| Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes - 44093 - Nantes Cedex 1 - Loire-Atlantique - France | Contact (sur clinicalTrials) | ||||
| Polyclinique Vauban - 59300 - Valenciennes - Nord - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Participants may be without type 2 diabetes (T2D), or with T2D if their hemoglobin
A1c (HbA1c) is 10% or lower
- Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or
chronic kidney disease (CKD), as evidenced at least one of the following:
- Coronary artery disease
- Cerebrovascular disease
- Peripheral arterial disease
- Chronic kidney disease defined as:
- eGFR <45 millilitres/minute/1.73 meter squared (mL/min/1.73m^2) and UACR
>30 milligram/gram (mg/g) (0.030 mg/mg)
- eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g (0.100 mg/mg), or
- eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (0.300 mg/mg) (eGFR is
calculated by central lab based on Chronic Kidney Disease Epidemiology
Collaboration (CKD-EPI) creatinine-cystatin c equation as determined by
central lab)
- A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m^2)
- Participants may be without type 2 diabetes (T2D), or with T2D if their hemoglobin
A1c (HbA1c) is 10% or lower
- Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or
chronic kidney disease (CKD), as evidenced at least one of the following:
- Coronary artery disease
- Cerebrovascular disease
- Peripheral arterial disease
- Chronic kidney disease defined as:
- eGFR <45 millilitres/minute/1.73 meter squared (mL/min/1.73m^2) and UACR
>30 milligram/gram (mg/g) (0.030 mg/mg)
- eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g (0.100 mg/mg), or
- eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (0.300 mg/mg) (eGFR is
calculated by central lab based on Chronic Kidney Disease Epidemiology
Collaboration (CKD-EPI) creatinine-cystatin c equation as determined by
central lab)
- A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m^2)
Diabetes related:
- Participants have Type 1 Diabetes or any history of diabetic ketoacidosis
CV related:
- Participants have any of the following cardiovascular conditions ≤ 90 days prior to
randomization:
- Myocardial infarction
- Acute coronary syndrome
- Stroke, or
- Coronary, peripheral, or carotid artery arterial revascularization procedure.
- Have acute decompensated heart failure requiring hospitalization.
- Have New York Heart Association (NYHA) Classification Class IV heart failure at
screening
Kidney related:
- Participants have an eGFR <20 mL/min/1.73 m^2 at screening
- Have UACR >5000 mg/g (5.000 mg/mg) at screening
- Have received any form of dialysis ≤ 90 days from the date of randomization
- Have either undergone a kidney transplant or have a transplant procedure scheduled
Other medical conditions:
- Participants have had or plan to have a surgical treatment for obesity,
- Have a history of chronic or acute pancreatitis
- Have a family or personal history of medullary thyroid carcinoma or multiple
endocrine neoplasia (MEN) syndrome type 2
- Have a known clinically significant gastric emptying abnormality, such as severe
gastroparesis or gastric outlet obstruction