Recruiting

Phase 3

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

Sponsor:

Eli Lilly and Company

Code:

NCT06739122

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

Dulaglutide

Study Details

Brief summary:

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.

Conditions

Type 2 Diabetes

Study ID

NCT06739122

Start date

Jan 10, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

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

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dulaglutide

Participants will receive dulaglutide subcutaneously (SC)

Interventions

Dulaglutide

Administered SC

Primary outcome measure

Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through Week 26 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

520-626-3197

Principal Investigator:

Sunil Sinha

Arkansas Childrens Hospital

Recruiting

Little Rock, Arkansas, United States, 72202-3500

Contacts

505-272-5551

Principal Investigator:

Jon Oden

Division of Endocrinology, Diabetes, and Metabolism

Recruiting

Los Angeles, California, United States, 90027

Principal Investigator:

Lily Chao

UCLA Mattel Children's Hospital

Recruiting

Los Angeles, California, United States, 90095

Contacts

310-203-7631

Principal Investigator:

Vibha Singhal

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

415-514-6234

Principal Investigator:

Shylaja Sirinivasan

Yale Diabetes Research

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

203-737-7177

Principal Investigator:

Michelle Van Name

Emerson Clinical Research Institute

Recruiting

Washington D.C., District of Columbia, United States, 20009

Contacts

202-239-0777

Principal Investigator:

Julia Pineda

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

888-884-2327

Principal Investigator:

Shideh Majidi

Nemours Children's Health

Recruiting

Jacksonville, Florida, United States, 32207

Principal Investigator:

Camila Pereira-Eshraghi

D&H National Research Centers, Inc

Recruiting

Miami, Florida, United States, 33155

Contacts

786-375-6210

Principal Investigator:

Yanetsi Flores Landa

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

407-896-2901

Principal Investigator:

Konda Reddy

D&H Tamarac Research Center, LLC

Recruiting

Tamarac, Florida, United States, 33321

Contacts

786-375-6210

Principal Investigator:

Helena Gaviria

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Henry Rodriguez

Children's Healthcare of Atlanta - Center for Advanced Pediatrics

Recruiting

Atlanta, Georgia, United States, 30329

Principal Investigator:

Daniel Hsia

Centricity Research Columbus Endocrinology

Recruiting

Columbus, Georgia, United States, 31904

Principal Investigator:

Steven Leichter

St. Luke's Children's Endocrinology and Diabetes

Recruiting

Boise, Idaho, United States, 83712

Contacts

208-381-7340

Principal Investigator:

Daniel Flynn

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

312-307-9385

Principal Investigator:

Roxana Aguirre Castaneda

Center for Diabetes and Metabolic Diseases Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

317-278-9699

Principal Investigator:

Tamara Hannon

University of Iowa Stead Family Children's Hospitals

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

319-335-0077

Principal Investigator:

Michael Tansey

Norton Children's Endocrinology

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

502-588-3400

Principal Investigator:

Sara Watson

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

443-287-9032

Principal Investigator:

Risa Wolf

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

601-815-5000

Principal Investigator:

Nazmin Dixit

University of New Mexico Hospital

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

505-272-3073

Principal Investigator:

Michelle Hutchison

WBMD Pediatrics

Recruiting

Buffalo, New York, United States, 14203

Principal Investigator:

Kathleen Bethin

Cohen Children's Medical Center Division of Pediatric Endocrinology

Recruiting

Hyde Park, New York, United States, 11042

Contacts

516-472-3750

Principal Investigator:

Benjamin Nwosu

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

315-464-9006

Principal Investigator:

David Hansen

UNC Children's Hospital

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

919-966-2333

Principal Investigator:

Nina Jain

Childrens Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

513-803-7274

Principal Investigator:

Ryan Brady

Cleveland Clinic Childrens Outpatient Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

216-636-2828

Principal Investigator:

Roy Kim

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

405-271-6764

Principal Investigator:

Jeanie Tryggestad

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Steven Willi

St Christophers Hospital For Children

Recruiting

Philadelphia, Pennsylvania, United States, 19134

Contacts

215-427-7911

Principal Investigator:

Elizabeth Suarez

Prisma Health Pediatric Endocrinology

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

803-434-7990

Principal Investigator:

Alison Lunsford

Prisma Health Midlands

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

864-454-5656

Principal Investigator:

Elaine Apperson

Research Institute of Dallas

Recruiting

Dallas, Texas, United States, 75231

Contacts

248-817-4331

Principal Investigator:

Heidi Shea

Texas Childrens Hospital

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Siripoom McKay

UT Health Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

713-500-7257

Principal Investigator:

Anvi Shah

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Principal Investigator:

Jacqueline Chan

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

206-987-3897

Principal Investigator:

Petter Bjornstand

Children's Wisconsin - Milwaukee Campus

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

414-955-8486

Principal Investigator:

Susanne Cabrera

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-07.