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

Completed · Phase 1

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT06362265

Run by

Eli Lilly and Company

People needed

15

Starts

2024-10-10

Expected to finish

2026-01-02

Last updated by the study team

2026-03-24

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Healthcare of Atlanta - Center for Advanced Pediatrics — Atlanta, Georgia, United States
• Centricity Research Columbus Endocrinology — Columbus, Georgia, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• UBMD Pediatrics — Buffalo, New York, United States
• NYU Langone — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Lifedoc Research - Lenox Park Drive — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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