RecruitingPhase 1NCT06362265

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

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


Sponsor

Eli Lilly and Company

Enrollment

22 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 10 YearsMax Age: 17 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

Interventions

DRUGLY3209590

Administered SC.


Locations(10)

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

View Full Details on ClinicalTrials.gov

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NCT06362265


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