800 Participants Needed

Retatrutide vs Tirzepatide for Obesity

(TRIUMPH-5 Trial)

Recruiting at 68 trial locations
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MK
AJ
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Thomas Schnitzer profile photo
Stacey Layle profile photo
Wilner Jeudy, MD profile photo
Awawu Igbinadolor profile photo
Overseen ByAwawu Igbinadolor
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?

The main purpose of this study is to evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. The study will last about 89 weeks.

Do I need to stop taking my current medications for the trial?

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

Is tirzepatide safe for humans?

Tirzepatide has been shown to be generally safe in humans, with the most common side effects being mild to moderate stomach-related issues. These side effects are similar to those seen with other drugs in the same class and usually do not lead to stopping the treatment.12345

How is the drug Retatrutide vs Tirzepatide unique for obesity treatment?

Tirzepatide is unique because it acts as a dual agonist for both GLP-1 and GIP receptors, which helps lower blood sugar and reduce appetite, making it potentially more effective for weight loss compared to other treatments that target only GLP-1 receptors. This dual action could offer better results for people with obesity, especially those with type 2 diabetes, compared to existing GLP-1 based therapies.46789

What data supports the effectiveness of the drug Retatrutide and Tirzepatide for obesity?

Research shows that Tirzepatide, a drug similar to Retatrutide, is effective for weight loss in people with obesity and type 2 diabetes, helping them lose weight and improve blood sugar levels. This suggests that Retatrutide, which is being compared to Tirzepatide, may also be effective for weight management.245710

Who Is on the Research Team?

C1

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Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with obesity who are looking to participate in a study lasting approximately 89 weeks. The specific eligibility criteria have not been provided, but typically participants must meet certain health conditions and agree to follow the study's procedures.

Inclusion Criteria

Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight.

Exclusion Criteria

I have had or am planning to have a procedure or device treatment for obesity.
I have a history of pancreatitis.
Have a self-reported change in body weight >5 kilograms (kg) (11 pounds) within 90 days before screening
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 either retatrutide or tirzepatide administered subcutaneously

85 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Retatrutide
  • Tirzepatide
Trial Overview The trial is testing the effectiveness and safety of two drugs: Retatrutide (LY3437943) and Tirzepatide (LY3298176). Participants will receive one of these medications to compare their impact on obesity over the course of the study.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: RetatrutideExperimental Treatment1 Intervention
Group II: TirzepatideActive Control1 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

Published Research Related to This Trial

Tirzepatide significantly reduces body weight in patients with type 2 diabetes and obesity, with an average weight loss of -9.81 kg compared to placebo, based on a meta-analysis of 10 studies involving 9,873 patients.
While tirzepatide is effective for weight loss, it has a higher incidence of gastrointestinal side effects compared to placebo, although serious adverse events and hypoglycemia are less common, indicating a need for monitoring these reactions during treatment.
Weight loss efficiency and safety of tirzepatide: A Systematic review.Lin, F., Yu, B., Ling, B., et al.[2023]
Tirzepatide (Mounjaro™) is a new treatment for type 2 diabetes that acts on both GIP and GLP-1 receptors, showing strong results in lowering blood glucose and promoting weight loss based on evidence from five SURPASS clinical trials.
The safety profile of tirzepatide is similar to that of existing GLP-1 receptor agonists, making it a promising option for early intervention in managing type 2 diabetes.
New Drug: Tirzepatide (Mounjaro™).Gettman, L.[2023]
Tirzepatide significantly improved blood glucose levels and reduced body weight in type 2 diabetes patients compared to dulaglutide over a 52-week period.
After stopping tirzepatide, patients experienced a rapid increase in blood glucose levels and weight regain, indicating the need for ongoing treatment or careful monitoring after discontinuation.
Effect on Hemoglobin A1c (HbA1c) and Body Weight After Discontinuation of Tirzepatide, a Novel Glucose-Dependent Insulinotropic Peptide (GIP) and Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist: A Single-Center Case Series Study.Kubota, M., Yamamoto, K., Yoshiyama, S.[2023]

Citations

Weight loss efficiency and safety of tirzepatide: A Systematic review. [2023]
New Drug: Tirzepatide (Mounjaro™). [2023]
Effect on Hemoglobin A1c (HbA1c) and Body Weight After Discontinuation of Tirzepatide, a Novel Glucose-Dependent Insulinotropic Peptide (GIP) and Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist: A Single-Center Case Series Study. [2023]
Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. [2023]
A Novel Dual Incretin Agent, Tirzepatide (LY3298176), for the Treatment of Type 2 Diabetes Mellitus and Cardiometabolic Health. [2022]
Tirzepatide: Clinical review of the "twincretin" injectable. [2023]
Efficacy and Safety of Tirzepatide in Adults With Type 2 Diabetes: A Perspective for Primary Care Providers. [2023]
A systematic review of the safety of tirzepatide-a new dual GLP1 and GIP agonist - is its safety profile acceptable? [2023]
Efficacy and Safety of Tirzepatide in Type 2 Diabetes and Obesity Management. [2023]
Beyond glycemia: Comparing tirzepatide to GLP-1 analogues. [2023]
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