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A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes

RecruitingPhase 3

A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Once-Daily Oral Orforglipron Compared With Once-Weekly Dulaglutide in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes

Who can join

Ages 10 to 17 · All sexes

Full eligibility criteria
Inclusion Criteria:

* Have type 2 diabetes treated with diet and exercise and metformin and/or basal insulin
* Have HbA1c \> 6.5% to ≤ 11.0% at screening
* Have a body weight ≥50 kilograms (kg) (110 pounds) and a body mass index (BMI) of \>85th percentile

Exclusion Criteria:

* Have type 1 diabetes
* After the type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
* Have had at least one episode of severe hypoglycemia and/or at least one episode of hypoglycemic unawareness within the last 6 months before screening
* Have a history of pancreatitis or gallbladder disease
* Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
* Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or (SGLT2) inhibitors within 90 days prior to screening
* Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 90 days prior to screening

About the study

This study looks at how well a medicine called orforglipron works compared to another medicine called dulaglutide in pediatric participants aged 10 to less than 18 years with type 2 diabetes. The study will also check how safe these medicines are and how the body processes them.

Participation in the study will last about 61 weeks.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 170 · Started: Jul 8, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07668336

Locations in the U.S.

CaliforniaSutter Valley Medical Foundation (SVMF) Pediatric Endocrinology, Sacramento
Rady Children's Hospital, San Diego (Not yet recruiting)
ConnecticutStamford Therapeutics Consortium, Stamford
GeorgiaChildren's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP), Atlanta (Not yet recruiting)
CenExel iResearch, LLC, Decatur
IdahoMedical Research Partners, Ammon
KansasCotton O'Neil Diabetes & Endocrinology, Topeka
New YorkSUNY Upstate Medical University, Syracuse (Not yet recruiting)
Advantage Clinical Trials, The Bronx
OklahomaCentral States Research, Tulsa
PennsylvaniaFrontier Clinical Research, LLC, Smithfield
TennesseeVanderbilt Health One Hundred Oaks, Nashville (Not yet recruiting)
TexasGadolin Research, Beaumont
Driscoll Children's Hospital, Corpus Christi
Proactive Clinical Research LLC, Edinburg
Consano Clinical Research, LLC, Shavano Park
Victoria Clinical Research Group, Victoria

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.