Retatrutide for Obesity

(TRIUMPH-8 Trial)

Not yet recruiting at 31 trial locations
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Pi
Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eli Lilly and Company
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a drug called retatrutide for weight loss. Participants will receive either retatrutide or a placebo (a treatment with no active drug) to compare the drug's effectiveness against no treatment. The trial seeks individuals with a BMI of 30 or higher, or a BMI of 27 or higher with conditions like high blood pressure or sleep apnea, who have struggled to lose weight through dieting. Participants will be involved for about 65 weeks and will attend around 18 visits. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking weight loss treatment.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that retatrutide is likely to be safe for humans?

Research has shown that retatrutide is generally safe for individuals with obesity. Studies have found that it aids in significant weight loss and is considered safe for adults with obesity. Most participants experienced expected side effects, such as mild nausea and diarrhea, which are common with similar treatments. No major safety issues have been reported. However, retatrutide has not yet received FDA approval for general use, so staying updated on any new safety information is important.12345

Why do researchers think this study treatment might be promising?

Retatrutide is unique because it targets obesity by acting on multiple hormone pathways, which is different from most current treatments that focus on a single pathway. This new mechanism of action could lead to more effective weight loss and improved metabolic health. Researchers are excited about Retatrutide because it offers the possibility of better results with fewer side effects compared to existing options like GLP-1 receptor agonists. Additionally, the subcutaneous delivery method of Retatrutide allows for potentially more consistent and sustained therapeutic effects.

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

Research has shown that retatrutide aids weight loss in people with obesity. In previous studies, participants experienced significant weight loss with this treatment. One study found that those on the highest dose lost an average of 16.9% of their body weight. Another study reported weight loss of up to 24.2% after 48 weeks. This trial will test different doses of retatrutide, and these findings suggest that retatrutide can significantly reduce body weight in people with obesity.12467

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 individuals who are overweight or have obesity. Participants will be involved in the study for about 65 weeks and should expect around 18 visits.

Inclusion Criteria

My BMI is over 30, or it's over 27 with a condition like high blood pressure.
Have at least one unsuccessful attempt to lose weight by dieting

Exclusion Criteria

I have a history of MTC or MEN-2 in my family or myself.
I haven't had a heart attack, stroke, or severe heart issues in the last 3 months.
I have not taken any weight loss drugs in the last 90 days.
See 5 more

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 for body weight reduction

61 weeks
Approximately 18 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Retatrutide
Trial Overview The study aims to test the effectiveness and safety of a new medication called Retatrutide, comparing it with a placebo (a substance with no active drug) to see if it helps reduce body weight.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Retatrutide Dose 2Experimental Treatment1 Intervention
Group II: Retatrutide Dose 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

Triple–Hormone-Receptor Agonist Retatrutide for ObesityIn adults with obesity, retatrutide treatment for 48 weeks resulted in substantial reductions in body weight.
Efficacy and safety of retatrutide, a novel GLP-1, GIP, and ...The observed body weight reductions were dose dependent and substantial, with the 12 mg dose group achieving a mean weight reduction of 16.94% ...
Perceived benefits of treatment for obesity with retatrutideParticipants receiving retatrutide 4/8/12 mg experienced the highest mean reduction in weight (-26.2 kg; 23.8% reduction) from baseline to the ...
San Diego, CaliforniaPeople taking retatrutide also lost more weight than those who took placebo – the average weight reduction for the 12 mg group was 16.9% (17.2 ...
Triple hormone receptor agonist retatrutide for metabolic ...In a phase 2 study of retatrutide in people with obesity who did not have T2D, a weight reduction up to 24.2% was observed after 48 weeks.
FDA's Concerns with Unapproved GLP-1 Drugs Used for ...FDA has warned companies that have illegally sold unapproved drugs containing semaglutide, tirzepatide or retatrutide that are falsely labeled “for research ...
Retatrutide Is a New GLP-1 Hit. But Is It Legal?Retatrutide shows big weight loss potential but isn't FDA-approved. Here's what to know about its safety and legal risks.
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