Recruiting
A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
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.
ClinicalTrials.gov IDNCT06739122
PhasePHASE3
Enrollment55
SponsorEli Lilly and Company
Age10 Years
SexALL
Conditions studied
Type 2 Diabetes
About this study
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.
Interventions
- Drug: Dulaglutide — Administered SC
Primary outcomes
- Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration (Baseline through Week 26)
Eligibility information
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
Study locations
- University of Arizona, Tucson, Arizona 85724 United States
- Arkansas Childrens Hospital, Little Rock, Arkansas 72202-3500 United States
- Division of Endocrinology, Diabetes, and Metabolism, Los Angeles, California 90027 United States
- UCLA Mattel Children's Hospital, Los Angeles, California 90095 United States
- University of California, San Francisco, San Francisco, California 94158 United States
- Children's Hospital of Colorado, Denver, Colorado 80045 United States
- Yale Diabetes Research, New Haven, Connecticut 06511 United States
- Emerson Clinical Research Institute, Washington D.C., District of Columbia 20009 United States
- Children's National Medical Center, Washington D.C., District of Columbia 20010 United States
- Nemours Children's Health, Jacksonville, Florida 32207 United States
Showing 10 of 51 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.