Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Single Dose Study to Evaluate the Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus
The main purpose of this study is to evaluate how much of LY3209590 gets into the blood stream after a single dose and how long it takes the body to remove it in pediatric participants with Type 2 Diabetes Mellitus (T2DM). The study will last for approximately 100 days.
| Status | Not yet recruiting |
| Enrollment | 22 |
| Est. completion date | November 2026 |
| Est. primary completion date | November 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 10 Years to 17 Years |
| Eligibility | 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 in the last 90 days - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Healthcare of Atlanta - Center for Advanced Pediatrics | Atlanta | Georgia |
| United States | Johns Hopkins Hospital | Baltimore | Maryland |
| United States | Joslin Diabetes Center | Boston | Massachusetts |
| United States | UBMD Pediatrics | Buffalo | New York |
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| United States | Children's Hospital Los Angeles | Los Angeles | California |
| United States | University of Louisville, Norton Children's Research Institute | Louisville | Kentucky |
| United States | NYU Langone | New York | New York |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | Honor Health Research Institute | Scottsdale | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590 | Predose up to 65 days post dose | ||
| Primary | PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590 | Predose up to 65 days post dose | ||
| Secondary | Change from Baseline in Fasting Glucose | Baseline, 65 days |
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