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Evaluating dulaglutide dosing in children with Type 2 diabetes

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

Phase 3 Interventional Eli Lilly and Company · NCT06739122

This study is testing different doses of dulaglutide to see how well it helps children with Type 2 diabetes who are already using diet and other medications.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment55 (estimated)
Ages10 Years to 17 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations51 sites (Tucson, Arizona and 50 other locations)
Trial IDNCT06739122 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of different doses of dulaglutide, a medication for managing Type 2 diabetes, in pediatric participants. The trial will involve children who are already being treated with diet, exercise, and stable doses of metformin or basal insulin. Participants will be monitored over an 8-month period to evaluate the safety and efficacy of the treatment. The goal is to identify optimal dosing options for this age group.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 10-17 with Type 2 diabetes who are currently on a stable regimen of diet, exercise, and metformin or basal insulin.

Not a fit: Patients with Type 1 diabetes or those with a history of severe hypoglycemia or certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide tailored dosing options for children with Type 2 diabetes, improving their management and health outcomes.

How similar studies have performed: Previous studies on dulaglutide in adults have shown positive outcomes, but this specific approach in pediatric populations is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Tucson, Arizona and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Type 2 Diabetes
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.