Retatrutide for Type 2 Diabetes and Obesity

(TRIUMPH-2 Trial)

Recruiting at 139 trial locations

Overseen By Joseph Soufer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing retatrutide, a medication for people with type 2 diabetes who are overweight or obese, including some with sleep apnea. The medication aims to help control blood sugar levels and may also aid in weight loss.

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

Eligibility Criteria

This trial is for adults with Type 2 Diabetes and a BMI of at least 27, who have tried to lose weight unsuccessfully. Participants may also have moderate-to-severe obstructive sleep apnea (OSA) but should not be on certain OSA treatments or recent weight loss drugs. They mustn't have had significant weight changes recently or any history of specific thyroid cancers.

Inclusion Criteria

You have a moderate-to-severe obstructive sleep apnea, which is confirmed by a specific test called polysomnography.

I have used PAP therapy for 3 months and can stop it for 7 days before sleep studies.

You have tried to lose weight by changing your diet before, but it didn't work.

Exclusion Criteria

I have had pancreatitis.

I haven't used stimulants like modafinil or amphetamines in the last 3 months.

I have lost or gained more than 11 pounds in the last 3 months.

Treatment Details

Interventions

• Retatrutide (GLP-1 Receptor Agonist)

Trial Overview The study tests the effectiveness and safety of Retatrutide in people with Type 2 Diabetes who are overweight or obese, including some with OSA. It's an approximately 89-week study involving up to 24 visits, comparing Retatrutide against a placebo.

Participant Groups

Group I: Retatrutide Dose 3 Experimental Treatment 1 Intervention

Participants will receive retatrutide SC.

Group II: Retatrutide Dose 2 Experimental Treatment 1 Intervention

Participants will receive retatrutide SC.

Group III: Retatrutide Dose 1 Experimental Treatment 1 Intervention

Participants will receive retatrutide subcutaneously (SC).

Group IV: 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