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A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus
RECRUITINGPhase 1Sponsored by Eli Lilly and Company
Actively Recruiting
PhasePhase 1
SponsorEli Lilly and Company
Started2024-10-10
Est. completion2026-11
Eligibility
Age10 Years – 17 Years
Healthy vol.Accepted
Locations10 sites
View on ClinicalTrials.gov →
NCT06362265
Summary
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.
Eligibility
Age: 10 Years – 17 YearsHealthy volunteers accepted
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
Conditions2
DiabetesType 2 Diabetes Mellitus
Locations10 sites
Children's Hospital Los Angeles
Los Angeles, California, 90027
323-361-7116
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, 30329
404-785-5437
Centricity Research Columbus Endocrinology
Columbus, Georgia, 31904
706-996-2921
Johns Hopkins Hospital
Baltimore, Maryland, 21287
410-955-6463
Joslin Diabetes Center
Boston, Massachusetts, 02215
617-732-2603
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Actively Recruiting
PhasePhase 1
SponsorEli Lilly and Company
Started2024-10-10
Est. completion2026-11
Eligibility
Age10 Years – 17 Years
Healthy vol.Accepted
Locations10 sites
View on ClinicalTrials.gov →
NCT06362265