A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus
- Registration Number
- NCT06362265
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 22
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LY3209590 LY3209590 LY3209590 administered subcutaneously (SC).
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590 Predose up to 65 days post dose PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590 Predose up to 65 days post dose
- Secondary Outcome Measures
Name Time Method Change from Baseline in Fasting Glucose Baseline, 65 days
Trial Locations
- Locations (11)
Honor Health Research Institute
🇺🇸Scottsdale, Arizona, United States
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