RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-10

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06362265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

CONTACT

13176154559

ClinicalTrials.gov@lilly.com

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

STUDY_DIRECTOR

Eli Lilly and Company

Study Locations (Sites)

Honor Health Research Institute

Scottsdale, Arizona, 85258

United States

Children's Hospital Los Angeles

Los Angeles, California, 90027

United States

University of South Florida

Tampa, Florida, 33624

United States

Children's Healthcare of Atlanta - Center for Advanced Pediatrics

Atlanta, Georgia, 30329

United States

Centricity Research Columbus Endocrinology

Columbus, Georgia, 31904

United States

Johns Hopkins Hospital

Baltimore, Maryland, 21287

United States

Joslin Diabetes Center

Boston, Massachusetts, 02215

United States

UBMD Pediatrics

Buffalo, New York, 14203

United States

NYU Langone

New York, New York, 10016

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-10

Study Completion Date2026-11

Study Record Updates

Study Start Date2024-10-10

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

Insulin

Additional Relevant MeSH Terms

Type 2 Diabetes Mellitus