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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362265
• Other study ID #: 18437
• Secondary ID: I8H-MC-BDDB
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: November 2026

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 13176154559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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 in the last 90 days
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• LY3209590
Administered SC.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta - Center for Advanced Pediatrics	Atlanta	Georgia
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	UBMD Pediatrics	Buffalo	New York
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	University of Louisville, Norton Children's Research Institute	Louisville	Kentucky
United States	NYU Langone	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Honor Health Research Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590		Predose up to 65 days post dose
Primary	PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590		Predose up to 65 days post dose
Secondary	Change from Baseline in Fasting Glucose		Baseline, 65 days