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Clinical Trials in the USA / NCT06739122
Recruiting Phase 3

A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

NCT06739122 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2025-01-10
Last updated
2026-08-07

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

Dulaglutide

Dulaglutide: Administered SC

Study summary

The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.

Eligibility

Sex
ALL
Min age
10 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Have Type 2 diabetes treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to screening. * Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of \>85th percentile Exclusion Criteria: * Have Type 1 diabetes * Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or dulaglutide within 8 weeks prior to screening * After the Type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome * Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) * Have prior chronic, recurrent, or idiopathic pancreatitis, or known gallbladder disease * Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 8 weeks prior to screening

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
University of Arizona Tucson Arizona Recruiting
Arkansas Childrens Hospital Little Rock Arkansas Recruiting
Division of Endocrinology, Diabetes, and Metabolism Los Angeles California Recruiting
UCLA Mattel Children's Hospital Los Angeles California Recruiting
University of California, San Francisco San Francisco California Recruiting
Children's Hospital of Colorado Denver Colorado Not Yet Recruiting
Yale Diabetes Research New Haven Connecticut Recruiting
Emerson Clinical Research Institute Washington D.C. District of Columbia Recruiting
Children's National Medical Center Washington D.C. District of Columbia Recruiting
Nemours Children's Health Jacksonville Florida Recruiting
D&H National Research Centers, Inc Miami Florida Recruiting
AdventHealth Orlando Orlando Florida Recruiting
D&H Tamarac Research Center, LLC Tamarac Florida Recruiting
University of South Florida Tampa Florida Recruiting
Children's Healthcare of Atlanta - Center for Advanced Pediatrics Atlanta Georgia Recruiting
Centricity Research Columbus Endocrinology Columbus Georgia Recruiting
St. Luke's Children's Endocrinology and Diabetes Boise Idaho Recruiting
University of Illinois at Chicago Chicago Illinois Recruiting
Center for Diabetes and Metabolic Diseases Indiana University Indianapolis Indiana Recruiting
University of Iowa Stead Family Children's Hospitals Iowa City Iowa Recruiting
Norton Children's Endocrinology Louisville Kentucky Recruiting
Johns Hopkins University School of Medicine Baltimore Maryland Recruiting
University of Mississippi Medical Center Jackson Mississippi Recruiting
University of New Mexico Hospital Albuquerque New Mexico Recruiting
WBMD Pediatrics Buffalo New York Recruiting
Cohen Children's Medical Center Division of Pediatric Endocrinology Hyde Park New York Recruiting
SUNY Upstate Medical University Syracuse New York Recruiting
UNC Children's Hospital Chapel Hill North Carolina Recruiting
Childrens Hospital Medical Center Cincinnati Ohio Recruiting
Cleveland Clinic Childrens Outpatient Center Cleveland Ohio Recruiting
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania Recruiting
St Christophers Hospital For Children Philadelphia Pennsylvania Recruiting
Prisma Health Pediatric Endocrinology Columbia South Carolina Recruiting
Prisma Health Midlands Greenville South Carolina Recruiting
Research Institute of Dallas Dallas Texas Recruiting
Texas Childrens Hospital Houston Texas Recruiting
UT Health Houston Houston Texas Recruiting
University of Utah Salt Lake City Utah Recruiting
Seattle Children's Hospital Seattle Washington Recruiting

+ 11 more sites — see the full list on the official registry below.

On this site

📄 Trulicity (dulaglutide) drug profile →

More Eli Lilly and Company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06739122 on ClinicalTrials.gov ↗ ← All trials in the USA