The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Li… (NCT06383390) | Clinical Trial Compass
Active — Not RecruitingPhase 3
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
United States, Argentina, Australia10,000 participantsStarted 2024-04-30
Plain-language summary
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.
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying retatrutide specifically in people who have both obesity and either cardiovascular disease or chronic kidney disease — does my combination of conditions and overall health profile make this worth discussing as a potential option?
2Since this is a Phase 3 trial, what do we know so far about retatrutide's safety profile, and are there any risks I should weigh carefully given my current heart or kidney function?
3The trial is no longer enrolling new participants — does that mean there are other ongoing studies of retatrutide or similar GLP-1-based medications where I might still be able to participate, or should we focus on approved treatments instead?
4One of the main things this trial is measuring is whether retatrutide can delay serious kidney outcomes like end-stage kidney disease or a major drop in kidney filtering ability — given where my kidney function stands right now, how does that change what treatments you'd recommend for me?
5Are there currently approved medications that work in a similar way to retatrutide that you'd consider for my cardiovascular or kidney disease, while we wait for results from trials like this one to become available?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to First Occurrence of Composite Endpoints
Timeframe: Randomization up to Study Completion (Approximate 248 Weeks)
2
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 Death
Timeframe: Randomization up to Study Completion (Approximate 248 Weeks)