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

Phase 3

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: Dulaglutide

• Registration Number: NCT06739122
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-13
• Study First Posted: 2024-12-18
• Study Start: 2025-01-10
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-23
• Primary Completion: 2026-06
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dulaglutide	Dulaglutide	Participants will receive dulaglutide subcutaneously (SC)

Primary Outcome Measures

Name	Time	Method
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	A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide	Predose through Week 30
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 26
Percent Change from Baseline in Body Weight	Baseline, Week 26
Change from Baseline in Total Cholesterol	Baseline, Week 26
Change from Baseline in the EQ-5D-Y-5L	Baseline, Week 26
Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-B)	Baseline, Week 26
PK: Maximum Observed Concentration (Cmax) of Dulaglutide	Predose through Week 30

Trial Locations

Locations (29)

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, 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

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