Tests higher dulaglutide doses in children with type 2 diabetes
Tests two dulaglutide doses in children aged 10 to 17 with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
Key facts
- Where
- Albuquerque, Atlanta, Baltimore, Boise, Buffalo, Chapel Hill, Chicago, Cincinnati, Cleveland, Columbia, Columbus, Dallas, Denver, Greenville, Houston, Hyde Park, Indianapolis, Iowa City, Jackson, Jacksonville, Little Rock, Los Angeles, Louisville, Miami, Milwaukee, New Haven, Oklahoma City, Orlando, Philadelphia, Salt Lake City, San Francisco, Seattle, Syracuse, Tamarac, Tampa, Tucson, and Washington D.C., United StatesSee the 41 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers aged 10 to 17 with type 2 diabetes who weigh at least 50 kg (110 lb) and have a high body mass index. They would take dulaglutide.
- Age
- 10 to 17 years
- Sex
- Boys and girls can both join.
- Disease stage
- Type 2 diabetes treated with diet, exercise and metformin and/or basal insulin. Body mass index above the 85th percentile.
- Earlier treatment
- The metformin and/or basal insulin dose must have been stable for at least 8 weeks before screening.
Main reasons for not taking part
- Type 1 diabetes
- Other glucose-lowering medicines (besides metformin, basal insulin or dulaglutide) in the 8 weeks before screening
- Diabetic ketoacidosis or hyperosmolar syndrome after the type 2 diabetes diagnosis
- Severe low blood sugar or unawareness of low blood sugar in the last 6 months
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 17 years old?
Source: NCT06739122, who can take part
Where in United States
- University of New Mexico HospitalAlbuquerque, United StatesTaking people
- Children's Healthcare of Atlanta Center for Advanced PediatricsAtlanta, United StatesTaking people
- Johns Hopkins University School Of MedicineBaltimore, United StatesTaking people
- St. Luke's Children's Endocrinology and DiabetesBoise, United StatesTaking people
- WBMD PediatricsBuffalo, United StatesTaking people
- UNC Children's HospitalChapel Hill, United StatesTaking people
- University of Illinois at ChicagoChicago, United StatesTaking people
- Childrens Hospital Medical CenterCincinnati, United StatesTaking people
- Cleveland Clinic Childrens Outpatient CenterCleveland, United StatesTaking people
- Prisma Health Pediatric EndocrinologyColumbia, United StatesTaking people
- Centricity Research Columbus EndocrinologyColumbus, United StatesTaking people
- Research Institute Of DallasDallas, United StatesTaking people
- Children's Hospital of ColoradoDenver, United StatesNot yet recruiting
- Prisma Health MidlandsGreenville, United StatesTaking people
- Texas Childrens HospitalHouston, United StatesTaking people
- UT Health HoustonHouston, United StatesTaking people
- Cohen Children's Medical Center Division of Pediatric EndocrinologyHyde Park, United StatesTaking people
- Center for Diabetes and Metabolic Diseases Indiana UniversityIndianapolis, United StatesTaking people
- University of Iowa Stead Family Children's HospitalsIowa City, United StatesTaking people
- University of Mississippi Medical CenterJackson, United StatesTaking people
- Nemours Children's HealthJacksonville, United StatesTaking people
- Arkansas Childrens HospitalLittle Rock, United StatesTaking people
- Division of Endocrinology, Diabetes, and MetabolismLos Angeles, United StatesTaking people
- UCLA Mattel Children's HospitalLos Angeles, United StatesTaking people
- Norton Children's EndocrinologyLouisville, United StatesTaking people
- D&H National Research Centers, IncMiami, United StatesTaking people
- Children's Wisconsin - Milwaukee CampusMilwaukee, United StatesTaking people
- Yale Diabetes ResearchNew Haven, United StatesTaking people
- University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
- AdventHealth OrlandoOrlando, United StatesTaking people
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesTaking people
- St Christophers Hospital For ChildrenPhiladelphia, United StatesTaking people
- University of UtahSalt Lake City, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
- Seattle Children's HospitalSeattle, United StatesTaking people
- SUNY Upstate Medical UniversitySyracuse, United StatesTaking people
- D&H Tamarac Research Center, LLCTamarac, United StatesTaking people
- University of South FloridaTampa, United StatesTaking people
- University of ArizonaTucson, United StatesTaking people
- Children's National Medical CenterWashington D.C., United StatesTaking people
- Emerson Clinical Research InstituteWashington D.C., United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT06739122
- Record updated
- 7 August 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Open-Label, Multicenter, Single-Arm Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Dulaglutide 3.0 mg and 4.5 mg in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus
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.
Inclusion: 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: 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; Have Type 1 diabetes; After the Type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome; Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2); Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or dulaglutide within 8 weeks prior to screening; Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.