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Retatrutide for Obesity

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants may be with or without type 2 diabetes (T2D) unless their hemoglobin A1c (HbA1c) is 10% or lower
Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD) as evidenced by 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), eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g, or eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (eGFR is calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin c equation as determined by central lab)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to study completion (approximate 248 weeks)
Awards & highlights

Study Summary

This trial aims to see if retatrutide can reduce serious heart problems and stop kidney function from getting worse in adults with a high body mass index and heart or kidney disease.

Who is the study for?
This trial is for adults with obesity (BMI of 27 or higher) who also have heart disease and/or chronic kidney disease. It's not specified who can't join, but typically those with conditions that could interfere with the study or pose a risk to their health are excluded.Check my eligibility
What is being tested?
The TRIUMPH-OUTCOMES trial is testing if retatrutide, given once weekly, can reduce serious heart complications or slow down kidney function decline in obese individuals compared to a placebo.See study design
What are the potential side effects?
While specific side effects aren't listed here, drugs like retatrutide often cause gastrointestinal issues such as nausea and diarrhea. They may also affect blood sugar levels and potentially cause allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My HbA1c level is 10% or lower, with or without type 2 diabetes.
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I have heart disease, stroke history, or kidney disease with specific test results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization up to study completion (approximate 248 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to study completion (approximate 248 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Time to First Occurrence of Composite Endpoints
Secondary outcome measures
Percentage change from Baseline in Albuminuria urinary albumin/creatinine ratio (UACR) in Participants with UACR ≥30 mg/g (0.03 mg/mg) at baseline
Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF
Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RetatrutideExperimental Treatment1 Intervention
Participants will receive escalated doses of retatrutide administered subcutaneously (SC) up to a maximum tolerated dose.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo administered SC.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,622 Previous Clinical Trials
3,206,775 Total Patients Enrolled
55 Trials studying Obesity
41,219 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
405,898 Total Patients Enrolled
38 Trials studying Obesity
20,938 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can we find a substantial number of medical centers conducting this research within the borders of the United States?

"The current phase of this research is underway at 349 different locations, including Lynwood, Lufkin, and Phoenix. Opting for a nearby site can reduce travel commitments when participating in the trial."

Answered by AI

Has Retatrutide received the FDA's stamp of approval?

"According to Power's evaluation, the safety rating for Retatrutide is graded as 3 due to its Phase 3 trial status. This signifies existing efficacy data and repeated safety findings."

Answered by AI

Are researchers currently accepting participants for this study?

"Information from clinicaltrials.gov shows that this particular trial is not presently seeking participants. Although initially listed on May 1st, 2024, with the most recent update on April 22nd, 2024, recruitment is currently closed. It's worth noting that there are a substantial number of other trials actively enrolling candidates - totaling at least 1721 studies elsewhere."

Answered by AI

Who else is applying?

What site did they apply to?
Valley Clinical Trials, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I really need to loose weight I'm up for my Second knee replacement I want a successful outcome and loosing a significant amount of weight would aid me in the outcome I seek.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Renal Function in Adults Living With Obesity (TRIUMPH-OUTCOMES)
2024. "The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Renal Function in Adults Living With Obesity (TRIUMPH-OUTCOMES)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06383390.
~6667 spots leftby Feb 2029
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