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

NCT06739122 · Eli Lilly and Company
In plain English

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Official title
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
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.
Eligibility criteria
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 design
Enrollment target: 55 participants
Allocation: na
Masking: none
Age groups: child
Timeline
Starts: 2025-01-10
Estimated completion: 2027-12
Last updated: 2026-03-27
Interventions
Drug: Dulaglutide
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)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (51)
University of ArizonaRecruiting
Tucson, Arizona, United States
Arkansas Childrens HospitalRecruiting
Little Rock, Arkansas, United States
Division of Endocrinology, Diabetes, and MetabolismRecruiting
Los Angeles, California, United States
UCLA Mattel Children's HospitalRecruiting
Los Angeles, California, United States
University of California, San FranciscoRecruiting
San Francisco, California, United States
Children's Hospital of ColoradoNot Yet Recruiting
Denver, Colorado, United States
Yale Diabetes ResearchRecruiting
New Haven, Connecticut, United States
Emerson Clinical Research InstituteRecruiting
Washington D.C., District of Columbia, United States
Children's National Medical CenterNot Yet Recruiting
Washington D.C., District of Columbia, United States
Nemours Children's HealthRecruiting
Jacksonville, Florida, United States
D&H National Research Centers, IncRecruiting
Miami, Florida, United States
AdventHealth OrlandoRecruiting
Orlando, Florida, United States
D&H Tamarac Research Center, LLCRecruiting
Tamarac, Florida, United States
University of South FloridaNot Yet Recruiting
Tampa, Florida, United States
Children's Healthcare of Atlanta - Center for Advanced PediatricsRecruiting
Atlanta, Georgia, United States
Centricity Research Columbus EndocrinologyRecruiting
Columbus, Georgia, United States
St. Luke's Children's Endocrinology and DiabetesRecruiting
Boise, Idaho, United States
University of Illinois at ChicagoRecruiting
Chicago, Illinois, United States
Center for Diabetes and Metabolic Diseases Indiana UniversityNot Yet Recruiting
Indianapolis, Indiana, United States
University of Iowa Stead Family Children's HospitalsNot Yet Recruiting
Iowa City, Iowa, United States
Norton Children's EndocrinologyRecruiting
Louisville, Kentucky, United States
Johns Hopkins University School of MedicineNot Yet Recruiting
Baltimore, Maryland, United States
University of Mississippi Medical CenterRecruiting
Jackson, Mississippi, United States
University of New Mexico HospitalRecruiting
Albuquerque, New Mexico, United States
WBMD PediatricsRecruiting
Buffalo, New York, United States
Cohen Children's Medical Center Division of Pediatric EndocrinologyRecruiting
Hyde Park, New York, United States
SUNY Upstate Medical UniversityRecruiting
Syracuse, New York, United States
UNC Children's HospitalRecruiting
Chapel Hill, North Carolina, United States
Childrens Hospital Medical CenterRecruiting
Cincinnati, Ohio, United States
Cleveland Clinic Childrens Outpatient CenterRecruiting
Cleveland, Ohio, United States
University of Oklahoma Health Sciences CenterRecruiting
Oklahoma City, Oklahoma, United States
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
St Christophers Hospital For ChildrenNot Yet Recruiting
Philadelphia, Pennsylvania, United States
Prisma Health Pediatric EndocrinologyRecruiting
Columbia, South Carolina, United States
Prisma Health MidlandsNot Yet Recruiting
Greenville, South Carolina, United States
Research Institute of DallasNot Yet Recruiting
Dallas, Texas, United States
Texas Childrens HospitalRecruiting
Houston, Texas, United States
UT Health HoustonNot Yet Recruiting
Houston, Texas, United States
University of UtahRecruiting
Salt Lake City, Utah, United States
Seattle Children's HospitalRecruiting
Seattle, Washington, United States
Children's Wisconsin - Milwaukee CampusNot Yet Recruiting
Milwaukee, Wisconsin, United States
Centro Medico Dra. Laura Maffei- Investigacion Clinica AplicadaNot Yet Recruiting
Buenos Aires, Argentina
Centro de Investigaciones Médicas Mar del PlataNot Yet Recruiting
Mar del Plata, Argentina
INECO Neurociencias OroñoNot Yet Recruiting
Rosario, Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.LNot Yet Recruiting
San Miguel de Tucumán, Argentina
Go Centro Medico San NicolásNot Yet Recruiting
San Nicolás, Argentina
Centro de Estudios de Investigacion Metabolicos y CardiovascularesNot Yet Recruiting
Ciudad Madero, Mexico
Hospital Angeles (HA) - PueblaNot Yet Recruiting
Puebla City, Mexico
Clínica CemainNot Yet Recruiting
Tampico, Mexico
Innovacion y Desarrollo de Estrategias en Salud SA de CVNot Yet Recruiting
Tlalpan, Mexico
Arké SMO S.A de C.VNot Yet Recruiting
Veracruz, Mexico