TRIUMPH-OUTCOMES
Brief description of study
The main purpose of this study is to learn more about retatrutide, an investigational treatment for participants with BMI of greater than or equal to 27 kg/m2 (kilogram per square meter) and heart related and/or kidney related disease. About 10,000 participants will be randomized to receive either retatrutide or placebo added to their existing SOC background medications. Participants will administer their retatrutide or placebo dose once weekly by sc injection using a single-dose pen.
Detailed description of study
This study uses retatrutide to see how well it works to help people with BMI of greater than or equal to 27 kg/m^2 and heart related and/or kidney related disease.
The first part of the study is the Screening Period, which is a minimum of 4 weeks long, and can be extended to more than 8 weeks. During this time, participants will undergo some tests, such as: obtaining medical and family history, obtaining vital signs, physical examinations, blood draws, urine collections, imaging tests, and questionnaires.
The Study Treatment Period of the study may last for about 5 years. This period is when the participants will receive either retatrutide or a placebo. The participant has a 50% chance of receiving retatrutide and a 50% chance of receiving the placebo, determined by chance. Neither the participant nor the study doctor will know which study drug the participant is getting.
During this time, the participant will take the study drug weekly by injection and may be given an increased dose of the study drug during the course of the study. The dose will gradually increase about every 4 weeks until the participant gets to the full regular dose.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
-
Age: - 99 Years
-
Gender: All
Inclusion
A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m^2)
Participants may be with or without type 2 diabetes (T2D) unless their hemoglobin A1c (HbA1c) is 10% or lower
Participants have established ASCVD and/or CKD, as evidenced at least one of the following: coronary artery disease, cerebrovascular disease, peripheral arterial disease, CKD
Exclusion
Diabetes related: Participants have Type 1 Diabetes or history of diabetic ketoacidosis
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 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
Participants have had or plan to have a surgical treatment for obesity
Find a site
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
