LY3209590 for Type 2 Diabetes in Children
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called LY3209590 (Insulin efsitora alfa) for children with Type 2 Diabetes to determine its absorption into the bloodstream and duration in the body. Researchers aim to understand how the body processes this medication after a single dose. Children who have had Type 2 Diabetes for at least 3 months, are not on insulin, and have stable blood sugar levels might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that participants should not have used insulin for at least 3 months before the study. If you are on insulin, you would need to stop it before joining the trial.
Is there any evidence suggesting that LY3209590 is likely to be safe for humans?
Research has shown that LY3209590, also known as insulin efsitora alfa, has been tested for safety in people with type 2 diabetes. Recent studies found that this treatment is generally well-tolerated. For instance, one study compared LY3209590 to insulin degludec, and both showed similar safety results. Another study found that LY3209590 had a safety profile comparable to daily insulin, meaning it didn't cause more side effects than usual insulin treatments.
These findings suggest that LY3209590 is generally safe and doesn't cause unexpected issues. However, since this research is still in the early stages, it's important to note that scientists are still learning about how the treatment works in children with type 2 diabetes. Always consult a healthcare provider about potential risks and benefits before joining any clinical trial.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for Type 2 diabetes in children, which often include oral medications and insulin injections, LY3209590 offers a new approach by being administered subcutaneously. This experimental treatment is a novel insulin receptor agonist, which means it works by directly targeting and activating insulin receptors, potentially leading to more efficient blood sugar control. Researchers are excited about LY3209590 because it may provide a more streamlined and effective method to manage diabetes, possibly reducing the frequency of doses and simplifying the treatment process for young patients.
What evidence suggests that LY3209590 might be an effective treatment for Type 2 Diabetes?
Research has shown that LY3209590, also known as insulin efsitora alfa, holds promise for managing diabetes. In earlier studies, it effectively controlled blood sugar in people with type 2 diabetes, similar to insulin degludec, a common insulin treatment. Specifically, those using LY3209590 maintained their blood sugar in the target range 64.3% of the time, compared to 61.2% for those using degludec. This suggests that LY3209590 can be a good option for managing blood sugar levels in people with type 2 diabetes. Additionally, the treatment did not show any serious safety concerns, such as severe low blood sugar episodes. Participants in this trial will receive LY3209590 administered subcutaneously.12367
Who Is on the Research Team?
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 clinical trial is for children and teenagers who have Type 2 Diabetes Mellitus. Participants will be involved in the study for about 100 days to see how their bodies handle a single dose of a new diabetes medication, LY3209590.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single subcutaneous dose of LY3209590
Follow-up
Participants are monitored for safety and pharmacokinetics after the single dose
What Are the Treatments Tested in This Trial?
Interventions
- LY3209590
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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