Not currently recruiting at 91 trial locations
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Overseen ByNeda Rasouli
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eli Lilly and Company
Must be taking: Metformin, SGLT2i
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 examines how well two medications, retatrutide and semaglutide, help people with Type 2 Diabetes manage blood sugar levels when metformin alone isn't sufficient. Researchers aim to assess the effectiveness and safety of these treatments over approximately 26 months. Participants will be divided into groups to receive different doses of retatrutide or semaglutide. Ideal candidates have Type 2 Diabetes, struggle with blood sugar control despite taking metformin, and face challenges like maintaining a stable weight for at least 90 days. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking diabetes treatments.
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 must have been on a stable diabetes treatment with metformin, with or without SGLT2 inhibitors, for at least 90 days before joining. If you're taking weight loss medications, you must stop them 90 days before the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that retatrutide is generally safe for people with type 2 diabetes. Studies have found its safety and tolerability to be similar to other approved diabetes treatments, with most people not experiencing serious side effects. Common side effects were mild, such as nausea, which often occurs with similar drugs.
Semaglutide, already approved by the FDA for treating type 2 diabetes, has been found safe for many people. While some side effects may occur, they are usually mild and manageable.
Overall, both retatrutide and semaglutide are considered safe. Retatrutide has shown similar safety to existing treatments, and semaglutide has proven its safety through FDA approval.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about retatrutide for type 2 diabetes because it offers a potentially new approach compared to existing treatments like metformin, sulfonylureas, and GLP-1 receptor agonists such as semaglutide. Retatrutide is unique because it is a triple agonist, meaning it targets three different receptors involved in glucose and energy balance, which might improve blood sugar control more effectively than current options. Additionally, with its subcutaneous administration, retatrutide could offer a convenient delivery method similar to semaglutide but with enhanced benefits. Overall, this new mechanism of action could lead to better outcomes for patients managing type 2 diabetes.
What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?
This trial will compare Retatrutide and Semaglutide for managing type 2 diabetes. Research has shown that Retatrutide, which participants in this trial may receive, can significantly reduce body weight and improve energy processing in people with type 2 diabetes. In studies, Retatrutide led to a noticeable decrease in total body fat compared to other treatments. Meanwhile, Semaglutide, another treatment option in this trial, is known for improving blood sugar levels and aiding weight loss. It has helped nearly half of the patients reach their target blood sugar levels and has shown effective weight reduction in many cases. Both treatments are under study for their potential to better manage type 2 diabetes.12356
Who Is on the Research Team?
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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 Type 2 Diabetes who aren't managing their blood sugar well using metformin alone or with an SGLT2 inhibitor. Participants should be committed to the study duration of about 26 months and up to 24 visits.
Inclusion Criteria
I have Type 2 Diabetes.
Are of stable weight for at least 90 days prior to screening
I have been taking at least 1500 mg of metformin daily for diabetes, with or without SGLT2i, for the last 90 days.
See 2 more
Exclusion Criteria
Have Type 1 Diabetes (T1D)
I have had or am planning to have surgery for weight loss.
Have a known clinically significant gastric emptying abnormality
See 11 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 semaglutide administered subcutaneously
26 months
Up to 24 visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
4-8 weeks
What Are the Treatments Tested in This Trial?
Interventions
Retatrutide Semaglutide
Trial Overview
The trial is testing the effectiveness and safety of a new diabetes medication, Retatrutide, compared to an existing one, Semaglutide. It aims to see which better controls blood sugar levels in participants over the course of the study.
How Is the Trial Designed?
Treatment groups
Experimental Treatment
Active Control
Group I: Retatrutide Dose Level 2Experimental Treatment1 Intervention
Participants will receive retatrutide administered SC.
Group II: Retatrutide Dose Level 1Experimental Treatment1 Intervention
Participants will receive retatrutide administered subcutaneously (SC).
Group III: SemaglutideActive Control1 Intervention
Participants will receive semaglutide administered SC.
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
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
Citations