Retatrutide for Obesity and Cardiovascular Disease

(TRIUMPH-3 Trial)

Recruiting at 203 trial locations

Overseen By Alan Jan Kivitz

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Weight loss drugs

Disqualifiers: Recent heart events, Type 1 diabetes, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 80 weeks

1800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a medication called retatrutide in people who have both obesity and heart disease. The study will last over two years to see if the medication is safe and effective.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot have taken weight loss drugs in the 90 days before the trial.

What makes the drug Retatrutide unique for treating obesity and cardiovascular disease?

Retatrutide is unique because it may offer a new approach to treating obesity and cardiovascular disease by potentially targeting different mechanisms compared to existing drugs like rimonabant, which focus on cannabinoid receptors. This could provide an alternative for patients who do not respond well to current treatments or experience side effects. ^{1 2 3 4 5}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with obesity (BMI ≥35) and a history of cardiovascular disease, such as heart attack, stroke, or arterial disease. Participants should have tried to lose weight unsuccessfully before. They can't join if they've had recent significant weight changes, certain surgeries or acute cardiovascular events, use of weight loss drugs within the last 90 days, Type 1 diabetes, or specific hereditary cancer syndromes.

Inclusion Criteria

Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²)

I have heart disease, including a past heart attack, stroke, or symptoms of poor blood flow in my legs.

You have tried to lose weight through dieting before, but it didn't work.

Exclusion Criteria

I or my family have a history of MTC or MEN-2.

I have had pancreatitis.

I have had or am planning to have surgery for weight loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive retatrutide or placebo subcutaneously once weekly

80 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

33 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Retatrutide

Trial Overview The study tests Retatrutide's effectiveness and safety in reducing body weight for those with obesity and CVD. It compares Retatrutide given weekly against a placebo over approximately 113 weeks to see which is better at managing these conditions.

How Is the Trial Designed?

Group I: Retatrutide Dose 2 Experimental Treatment 1 Intervention

Participants will receive retatrutide SC.

Group II: Retatrutide Dose 1 Experimental Treatment 1 Intervention

Participants will receive retatrutide subcutaneously (SC).

Group III: Placebo Placebo Group 1 Intervention

Participants will receive placebo.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

In a Phase 4 trial involving 222 patients with obesity and type 2 diabetes, rimonabant (20 mg/day) combined with lifestyle counseling led to significant improvements in body weight, body mass index, and HDL cholesterol after one year, compared to placebo.

Despite these benefits, rimonabant was associated with a deterioration in quality of life and showed no significant improvement in overall cardiovascular risk factors, leading to its suspension from the market due to psychiatric side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rimonabant improves obesity but not the overall cardiovascular risk and quality of life; results from CARDIO-REDUSE (CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USE). Boesten, JE., Kaper, J., Stoffers, HE., et al.[2019]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Rimonabant improves obesity but not the overall cardiovascular risk and quality of life; results from CARDIO-REDUSE (CArdiometabolic Risk reDuctIOn by Rimonabant: the Effectiveness in Daily practice and its USE). [2019]

2. Italy pubmed.ncbi.nlm.nih.gov

New approaches for the management of patients with multiple cardiometabolic risk factors. [2012]

3. England pubmed.ncbi.nlm.nih.gov

A one-year study to assess the safety and efficacy of the CB1R inverse agonist taranabant in overweight and obese patients with type 2 diabetes. [2017]

4. Singapore pubmed.ncbi.nlm.nih.gov

Novel therapies for cardiometabolic risk reduction and implications for clinical practice. [2018]

5. China pubmed.ncbi.nlm.nih.gov

Emerging pharmacotherapy for treating obesity and associated cardiometabolic risk. [2018]