A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
Recruiting now · Phase 3
Conditions studied: Type 2 Diabetes
In brief
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.
Key facts
- Study ID
- NCT06739122
- Run by
- Eli Lilly and Company
- People needed
- 55
- Starts
- 2025-01-10
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-08-07
Who can join
Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Arkansas Childrens Hospital — Little Rock, Arkansas, United States (enrolling)
- University of Arizona — Tucson, Arizona, United States (enrolling)
- UCLA Mattel Children's Hospital — Los Angeles, California, United States (enrolling)
- University of California, San Francisco — San Francisco, California, United States (enrolling)
- Division of Endocrinology, Diabetes, and Metabolism — Los Angeles, California, United States (enrolling)
- Yale Diabetes Research — New Haven, Connecticut, United States (enrolling)
- Emerson Clinical Research Institute — Washington D.C., District of Columbia, United States (enrolling)
- Children's National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
- Nemours Children's Health — Jacksonville, Florida, United States (enrolling)
- D&H National Research Centers, Inc — Miami, Florida, United States (enrolling)
- AdventHealth Orlando — Orlando, Florida, United States (enrolling)
- D&H Tamarac Research Center, LLC — Tamarac, Florida, United States (enrolling)
- University of South Florida — Tampa, Florida, United States (enrolling)
- Children's Healthcare of Atlanta - Center for Advanced Pediatrics — Atlanta, Georgia, United States (enrolling)
- Centricity Research Columbus Endocrinology — Columbus, Georgia, United States (enrolling)
- St. Luke's Children's Endocrinology and Diabetes — Boise, Idaho, United States (enrolling)
- University of Illinois at Chicago — Chicago, Illinois, United States (enrolling)
- Center for Diabetes and Metabolic Diseases Indiana University — Indianapolis, Indiana, United States (enrolling)
- University of Iowa Stead Family Children's Hospitals — Iowa City, Iowa, United States (enrolling)
- Norton Children's Endocrinology — Louisville, Kentucky, United States (enrolling)
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (enrolling)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)
- University of New Mexico Hospital — Albuquerque, New Mexico, United States (enrolling)
- WBMD Pediatrics — Buffalo, New York, United States (enrolling)
- Cohen Children's Medical Center Division of Pediatric Endocrinology — Hyde Park, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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