Retatrutide for Obesity

Phase 3

Recruiting

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)

Must not have

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

Participants have Type 1 Diabetes or history of diabetic ketoacidosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization up to study completion (approximate 248 weeks)

Awards & highlights

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had a heart attack, stroke, or heart failure in the last 3 months.

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I have Type 1 Diabetes or have had diabetic ketoacidosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization up to study completion (approximate 248 weeks)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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)

Time to Occurrence of All-Cause Death