Clinical trial

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

Active, not recruiting · Phase 3 · 1 countries · Registry ID NCT06383390

Active, not recruitingPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age45 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionAtherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)

Full registry criteria

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) 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

Treatments and study arms

Retatrutide

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

Time to First Occurrence of Composite EndpointsRandomization up to Study Completion (Approximate 248 Weeks)

A composite endpoint includes nonfatal myocardial infarction (MI), nonfatal stroke, cardiovascular (CV) death, or hospitalization or urgent visit due to heart failure (HF).

Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), ≥ 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal DeathRandomization up to Study Completion (Approximate 248 Weeks)

ESKD is defined as the following individual components: persistent eGFR \<15 mL/min/1.73 m\^2 confirmed by 2 measurements at least 4 weeks apart at the central laboratory, initiation of dialysis for at least 28 days, receiving a kidney transplant. Sustained decline in eGFR (≥40%) will be confirmed by a repeated measure at least 4 weeks after the first result.

Study locations

743 locations were listed when this page was built. The first 40 are shown.

Buenos Aires Macula S.A🇦🇷 Buenos Aires, Argentina