Skip to main content
OpenTrials
Completed

NCT Number: NCT06362265

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3209590

Drug

Administered SC.

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590

    Time frame: Predose up to 65 days post dose

  2. PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590

    Time frame: Predose up to 65 days post dose

Secondary outcomes

  1. Change from Baseline in Fasting Glucose

    Time frame: Baseline, 65 days

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 12, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.