Evaluating how LY3209590 affects children with Type 2 Diabetes
A Single Dose Study to Evaluate the Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus
This study is testing how a new diabetes medication affects children with Type 2 Diabetes to see how well their bodies absorb and process it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 11 sites (Scottsdale, Arizona and 10 other locations) |
| Trial ID | NCT06362265 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the pharmacokinetics of LY3209590, a medication for Type 2 Diabetes Mellitus, in pediatric participants. It will measure how much of the drug enters the bloodstream after a single dose and how long it takes for the body to eliminate it. The study will involve participants who have been diagnosed with Type 2 Diabetes for at least three months and will last approximately 100 days. The focus is on insulin-naïve children or those who have not used insulin for the past three months.
Who should consider this trial
Good fit: Ideal candidates are children aged 10-17 with Type 2 Diabetes Mellitus for at least three months and specific HbA1c levels.
Not a fit: Patients with severe hypoglycemia, renal impairment, or recent significant weight changes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for children with Type 2 Diabetes Mellitus.
How similar studies have performed: Other studies evaluating pharmacokinetics in pediatric populations have shown promise, but this specific approach with LY3209590 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with Type 2 Diabetes Mellitus (T2DM) for at least 3 months * Have Glycated hemoglobin (HbA1c) level of 6.5 percent (%) to 9.5% at screening * Have a body mass index equal to or less than 45.0 kilograms per square meter (kg/m²) * Participants are insulin naïve or have been without insulin treatment for at least 3 months prior to screening Exclusion Criteria: * Have had a severe hypoglycemia in the past 6 months * Have a history of renal impairment * Have had a blood transfusion or severe blood loss within last 90 days * Have had a significant weight gain or loss of approximately 6% or more within 3 months prior to screening. * Have a history of an active or untreated malignancy * Are receiving or received systemic glucocorticoid therapy * Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product
Where this trial is running
Scottsdale, Arizona and 10 other locations
- Honor Health Research Institute — Scottsdale, Arizona, United States (Not_yet_recruiting)
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
- Children's Healthcare of Atlanta - Center for Advanced Pediatrics — Atlanta, Georgia, United States (Recruiting)
- Centricity Research Columbus Endocrinology — Columbus, Georgia, United States (Recruiting)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
- Joslin Diabetes Center — Boston, Massachusetts, United States (Not_yet_recruiting)
- UBMD Pediatrics — Buffalo, New York, United States (Recruiting)
- NYU Langone — New York, New York, United States (Not_yet_recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Lifedoc Research - Lenox Park Drive — Memphis, Tennessee, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 13176154559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.