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
02 septembre 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
| Etablissement | Contact | Statut | Actualisé | ||
|---|---|---|---|---|---|
| Etablissement non spécifié, référez vous à la page NCT pour plus d'information Origine et niveau de fiabilité des données | |||||
Critères
Tous
- 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)
Exclusion Criteria:
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