A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
NCT ID: NCT06739122
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
55 participants
INTERVENTIONAL
2025-01-10
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dulaglutide
Participants will receive dulaglutide subcutaneously (SC)
Dulaglutide
Administered SC
Interventions
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Dulaglutide
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of \>85th percentile
Exclusion Criteria
* Have received treatment with any glucose-lowering agent(s) other than metformin or basal insulin 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
10 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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University of Arizona
Tucson, Arizona, United States
Arkansas Childrens Hospital
Little Rock, Arkansas, United States
Division of Endocrinology, Diabetes, and Metabolism
Los Angeles, California, United States
UCLA Mattel Children's Hospital
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Yale Diabetes Research
New Haven, Connecticut, United States
Emerson Clinical Research Institute
Washington D.C., District of Columbia, United States
Nemours Children's Health
Jacksonville, Florida, United States
D&H National Research Centers, Inc
Miami, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
D&H Tamarac Research Center, LLC
Tamarac, Florida, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States
Centricity Research Columbus Endocrinology
Columbus, Georgia, United States
St. Luke's Children's Endocrinology and Diabetes
Boise, Idaho, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Norton Children's Endocrinology
Louisville, Kentucky, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of New Mexico Hospital
Albuquerque, New Mexico, United States
WBMD Pediatrics
Buffalo, New York, United States
Cohen Children's Medical Center Division of Pediatric Endocrinology
Hyde Park, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
UNC Children's Hospital
Chapel Hill, North Carolina, United States
Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Childrens Outpatient Center
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Prisma Health Pediatric Endocrinology
Columbia, South Carolina, United States
Texas Childrens Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Facility Contacts
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Role: primary
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Related Links
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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)
Other Identifiers
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H9X-MC-GBGS
Identifier Type: OTHER
Identifier Source: secondary_id
27198
Identifier Type: -
Identifier Source: org_study_id