600 Participants Needed

Retatrutide for Obesity

(TRIUMPH-9 Trial)

Recruiting at 34 trial locations
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Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 safety and effectiveness of a new treatment called retatrutide for individuals who are overweight or have obesity but do not have type 2 diabetes. It examines various methods to gradually increase the dose of retatrutide to determine the most effective approach. Ideal candidates for this trial have a BMI of 30 or higher, or a BMI of 27 or higher with conditions like high blood pressure or sleep apnea, and have struggled to lose weight through dieting. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking 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 this trial's treatments are likely to be safe?

Research has shown that retatrutide is generally safe and well-tolerated. Studies have found that adults with obesity lost a significant amount of weight and experienced improved metabolism while using retatrutide. Importantly, the treatment proved safe for participants.

Although the FDA has not yet approved retatrutide, these findings suggest it could be a promising option for weight loss. Participants in previous studies did not report any unexpected harmful effects, making it a potential treatment worth considering for those interested in joining a clinical trial.12345

Why do researchers think this study treatment might be promising for obesity?

Retatrutide is unique because it targets multiple pathways involved in weight regulation, which sets it apart from many current obesity treatments that typically focus on a single hormone or receptor. Unlike existing medications like liraglutide or semaglutide, which primarily act on the GLP-1 receptor, retatrutide is a triple agonist, meaning it also engages the GIP and glucagon receptors. This multi-target approach may enhance weight loss and improve metabolic health more effectively. Researchers are excited about retatrutide because it could offer a more comprehensive solution to obesity, potentially leading to better outcomes for patients.

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

Research has shown that retatrutide holds promise for weight loss in individuals with obesity. One study revealed that participants lost between 22.8% and 24.2% of their weight after 48 weeks of treatment with doses ranging from 8 mg to 12 mg. Another study found that retatrutide led to an average weight loss of up to 24.2%, equating to about 26.2 kg for someone starting at a higher weight, after 48 weeks. Retatrutide affects three hormone receptors, slowing stomach emptying and reducing food intake, which aids in weight loss. Overall, these findings suggest retatrutide could be a highly effective treatment for obesity.13678

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 without type 2 diabetes who are living with obesity or overweight. The study will last approximately 113 weeks, and participants must meet certain health criteria to join.

Inclusion Criteria

Have a Body Mass Index (BMI) at screening ≥ 30 kilogram per square meter (kg/m2) OR ≥ 27 kg/m2 with presence of at least one of the following weight-related conditions at screening: high blood pressure, abnormal levels of lipid, obstructive sleep apnea, heart disease
Have at least one unsuccessful attempt to lose weight by dieting

Exclusion Criteria

I have had or am planning to have surgery for weight loss.
I have a history of pancreatitis.
I have diabetes (type 1 or type 2).
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 subcutaneously with different dose escalation schemes

109 weeks

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 is testing the effectiveness and safety of various dosing schedules of a medication called Retatrutide in managing obesity in people without type 2 diabetes.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Retatrutide Dose Escalation 3Experimental Treatment1 Intervention
Group II: Retatrutide Dose Escalation 2Experimental Treatment1 Intervention
Group III: Retatrutide Dose Escalation 1Experimental Treatment1 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 Obesity

In adults with obesity, retatrutide treatment for 48 weeks resulted in substantial reductions in body weight. (Funded by Eli Lilly; ClinicalTrials.gov number, ...

Lilly's triple agonist, retatrutide, delivered weight loss of up ...

Retatrutide—A Game Changer in Obesity Pharmacotherapy

Animal studies demonstrate retatrutide's ability to delay gastric emptying, reduce food intake, and promote weight loss, with superior efficacy ...

Retatrutide Peptide Results in Real Life: What 24% Weight ...

The trials show: Weight reductions of roughly 22.8–24.2% in a 48‑week obesity study at 8–12 mg doses.

Perceived benefits of treatment for obesity with retatrutide

Treatment with retatrutide was associated with a mean weight reduction of up to 17.5 % (18.7 kg) at 24 weeks and up to 24.2 % (26.2 kg) at 48 weeks in the 12 mg ...

Efficacy and safety of retatrutide, a novel GLP-1, GIP ... - PMC

Retatrutide demonstrated significant improvements in body weight and metabolic outcomes among adults with obesity and had an appropriate safety profile.

American Diabetes Association

Findings demonstrated that participants with obesity lost more than 24% of their starting body weight within 48 weeks of treatment with the ...

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.