DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06739122

RecruitingPhase 3

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

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

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

51

Recruiting sites

36

Enrollment

55

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•Age 10-17

Primary endpoint

•Serious AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06739122
Org study ID27198
Secondary IDH9X-MC-GBGSEli Lilly and Company

Timeline

Milestones

Study first posted2024-12-18actual
Study start2025-01-10actual
Last update posted2026-05-12actual
Primary completion2027-12estimated (month precision)
Study completion2027-12estimated (month precision)

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age10 Years
Maximum age17 Years
SexAll
Healthy volunteersNot 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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
3
Glycemic / diabetes
2
Weight & body composition
1
Cardiometabolic biomarkers
1
Patient-reported / QoL
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 26

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-B)

Time frame:Baseline, Week 26

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Total Cholesterol

Time frame:Baseline, Week 26

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change from Baseline in the EQ-5D-Y-5L

Time frame:Baseline, Week 26

EQ-5D index

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

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

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide

Time frame:Predose through Week 30

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PK: Maximum Observed Concentration (Cmax) of Dulaglutide

Time frame:Predose through Week 30

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.