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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)

RecruitingPhase 3

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

Who can join

Ages 10 to 17 · All sexes

Full 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

About the 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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 55 · Started: Jan 10, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06739122

Locations in the U.S.

ArizonaUniversity of Arizona, Tucson
ArkansasArkansas Childrens Hospital, Little Rock
CaliforniaDivision of Endocrinology, Diabetes, and Metabolism, Los Angeles
UCLA Mattel Children's Hospital, Los Angeles
University of California, San Francisco, San Francisco
ColoradoChildren's Hospital of Colorado, Denver (Not yet recruiting)
ConnecticutYale Diabetes Research, New Haven
District of ColumbiaChildren's National Medical Center, Washington D.C.
Emerson Clinical Research Institute, Washington D.C.
FloridaNemours Children's Health, Jacksonville
D&H National Research Centers, Inc, Miami
AdventHealth Orlando, Orlando
D&H Tamarac Research Center, LLC, Tamarac
University of South Florida, Tampa
GeorgiaChildren's Healthcare of Atlanta - Center for Advanced Pediatrics, Atlanta
Centricity Research Columbus Endocrinology, Columbus
IdahoSt. Luke's Children's Endocrinology and Diabetes, Boise
IllinoisUniversity of Illinois at Chicago, Chicago
IndianaCenter for Diabetes and Metabolic Diseases Indiana University, Indianapolis
IowaUniversity of Iowa Stead Family Children's Hospitals, Iowa City
KentuckyNorton Children's Endocrinology, Louisville
MarylandJohns Hopkins University School of Medicine, Baltimore
MississippiUniversity of Mississippi Medical Center, Jackson
New MexicoUniversity of New Mexico Hospital, Albuquerque
New YorkWBMD Pediatrics, Buffalo
Cohen Children's Medical Center Division of Pediatric Endocrinology, Hyde Park
SUNY Upstate Medical University, Syracuse
North CarolinaUNC Children's Hospital, Chapel Hill
OhioChildrens Hospital Medical Center, Cincinnati
Cleveland Clinic Childrens Outpatient Center, Cleveland
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
PennsylvaniaChildren's Hospital of Philadelphia, Philadelphia
St Christophers Hospital For Children, Philadelphia
South CarolinaPrisma Health Pediatric Endocrinology, Columbia
Prisma Health Midlands, Greenville
TexasResearch Institute of Dallas, Dallas
Texas Childrens Hospital, Houston
UT Health Houston, Houston
UtahUniversity of Utah, Salt Lake City
WashingtonSeattle Children's Hospital, Seattle
WisconsinChildren's Wisconsin - Milwaukee Campus, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.