NCT06739122RecruitingPhase 3
A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
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
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- First submitted
- 13 Dec 2024
- Start date
- 10 Jan 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 2 diabetes
- NCT number
- NCT06739122
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 55
- From 10 Jan 2025 to the primary completion date, Dec 2027
- 51 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Lab values
- Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or dulaglutide within 8 weeks prior to screening
Other
- Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months
Who the study is looking for
- 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
Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (51)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Centro de Investigaciones Medicas Mar Del Plata Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Not yet recruiting |
| INECO Neurociencias Oroño Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Recruiting |
| Go Centro Medico San Nicolás Coordinator of this site? Confirm its status | San Nicolás | Argentina | Recruiting |
| Centro de Estudios de Investigacion Metabolicos y Cardiovasculares Coordinator of this site? Confirm its status | Ciudad Madero | Mexico | Not yet recruiting |
| Hospital Angeles (HA) - Puebla Coordinator of this site? Confirm its status | Puebla City | Mexico | Not yet recruiting |
| Clínica Cemain Coordinator of this site? Confirm its status | Tampico | Mexico | Not yet recruiting |
| Innovacion y Desarrollo de Estrategias en Salud SA de CV Coordinator of this site? Confirm its status | Tlalpan | Mexico | Not yet recruiting |
| Arké SMO S.A de C.V Coordinator of this site? Confirm its status | Veracruz | Mexico | Not yet recruiting |
| University of New Mexico Hospital Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| Children's Healthcare of Atlanta Center for Advanced Pediatrics Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Johns Hopkins University School Of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| St. Luke's Children's Endocrinology and Diabetes Coordinator of this site? Confirm its status | Boise | United States | Recruiting |
| WBMD Pediatrics Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| UNC Children's Hospital Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Childrens Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Cleveland Clinic Childrens Outpatient Center Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Prisma Health Pediatric Endocrinology Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| Centricity Research Columbus Endocrinology Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Research Institute Of Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Children's Hospital of Colorado Coordinator of this site? Confirm its status | Denver | United States | Not yet recruiting |
| Prisma Health Midlands Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| UT Health Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Texas Childrens Hospital Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Cohen Children's Medical Center Division of Pediatric Endocrinology Coordinator of this site? Confirm its status | Hyde Park | United States | Recruiting |
| Center for Diabetes and Metabolic Diseases Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| University of Iowa Stead Family Children's Hospitals Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
| Nemours Children's Health Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Arkansas Childrens Hospital Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| UCLA Mattel Children's Hospital Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Division of Endocrinology, Diabetes, and Metabolism Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Norton Children's Endocrinology Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| D&H National Research Centers, Inc Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Children's Wisconsin - Milwaukee Campus Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Yale Diabetes Research Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| AdventHealth Orlando Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| St Christophers Hospital For Children Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| SUNY Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| D&H Tamarac Research Center, LLC Coordinator of this site? Confirm its status | Tamarac | United States | Recruiting |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| University of Arizona Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
| Children's National Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
| Emerson Clinical Research Institute Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.