A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus

Launched by ELI LILLY AND COMPANY · Apr 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called LY3209590 to understand how it works in the body of children and teenagers with Type 2 Diabetes Mellitus (T2DM). The main goal is to see how much of this medication enters the bloodstream after taking a single dose and how long it stays in the body. The study will take about 100 days, and they are currently looking for participants aged 1 to 17 who have had T2DM for at least three months and meet certain health criteria.

To be eligible, participants should have blood sugar levels that fall between 6.5% and 9.5%, and they should not be using insulin or have used it for at least three months before joining the study. However, those who have experienced severe low blood sugar recently, have kidney issues, or are in other medical studies cannot participate. If chosen to join, participants will have the opportunity to help researchers learn more about this medication, which could lead to better treatments for young people with diabetes in the future.

Gender

ALL

Eligibility 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