Retatrutide for Obesity and Cardiovascular Disease

(TRIUMPH-3 Trial)

Not currently recruiting at 227 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called retatrutide to determine if it can help people with obesity and heart disease lose weight and improve heart health. Participants will receive either one of two doses of retatrutide or a placebo (a dummy treatment) to compare effects. The trial seeks individuals who have struggled with weight loss, have a BMI of 35 or higher, and have experienced heart problems like a heart attack or stroke. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that retatrutide is generally safe for people with obesity. Studies have found that this treatment aids in significant weight loss and improves metabolic health without major safety concerns. Common side effects include mild nausea and diarrhea, but these are usually manageable. Importantly, current evidence considers retatrutide safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Retatrutide is unique because it targets multiple pathways involved in weight regulation and cardiovascular health, unlike current treatments that often focus on just one. Most obesity treatments, such as those targeting the GLP-1 receptor, work by controlling appetite or increasing insulin sensitivity. However, retatrutide not only acts on the GLP-1 receptor but also engages additional receptors like GIP and glucagon receptors, which may enhance weight loss and improve heart health more effectively. Researchers are excited about its potential to provide more comprehensive benefits in managing obesity and reducing cardiovascular risks.

What evidence suggests that retatrutide might be an effective treatment for obesity and cardiovascular disease?

Research has shown that retatrutide aids weight loss in people with obesity. One study found that adults taking retatrutide for 48 weeks lost over 20% of their body weight. This treatment also improved the body's handling of sugar and fats, benefiting overall health. In this trial, participants will receive either one of two doses of retatrutide or a placebo. Researchers are studying retatrutide for its potential to reduce heart problems, which is crucial for individuals with heart disease. Overall, evidence suggests that retatrutide could be a promising option for weight loss and heart health in those with obesity and heart issues. ^{1 2 3 4 6}

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. nejm.org nejm.org/doi/full/10.1056/NEJMoa2301972

Triple–Hormone-Receptor Agonist Retatrutide for Obesity In adults with obesity, retatrutide treatment for 48 weeks resulted in substantial reductions in body weight.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12026077/

Efficacy and safety of retatrutide, a novel GLP-1, GIP, and ... Retatrutide demonstrated significant improvements in body weight and metabolic outcomes among adults with obesity and had an appropriate safety profile.

3. trials.lilly.com trials.lilly.com/en-US/trial/479798

The Effect of Retatrutide Once Weekly on Cardiovascular ... The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06383390

Study Details | NCT06383390 | The Effect of Retatrutide ... The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the ...

5. nature.com nature.com/articles/s41591-024-03018-2

Triple hormone receptor agonist retatrutide for metabolic ... A 48-week phase 2 obesity study demonstrated weight reductions of 22.8% and 24.2% with retatrutide 8 and 12 mg, respectively.

6. mountsinai.org mountsinai.org/clinical-trials/effect-of-retatrutide-once-weekly-on-cardiovascular-outcomes-renal-function-in-adults-living-with-obesity-triumph-outcomes

The Effect of Retatrutide Once Weekly on Cardiovascular ... The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the ...