A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes
Starting soon · Phase 3
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT07668336
- Run by
- Eli Lilly and Company
- People needed
- 170
- Starts
- 2026-09-01
- Expected to finish
- 2030-03-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Rady Children's Hospital — San Diego, California, United States
- Stamford Therapeutics Consortium — Stamford, Connecticut, United States
- Children's Healthcare of Atlanta - Center for Advanced Pediatrics (CAP) — Atlanta, Georgia, United States
- CenExel iResearch, LLC — Decatur, Georgia, United States
- Medical Research Partners — Ammon, Idaho, United States
- Cotton O'Neil Diabetes & Endocrinology — Topeka, Kansas, United States
- SUNY Upstate Medical University — Syracuse, New York, United States
- Advantage Clinical Trials — The Bronx, New York, United States
- Central States Research — Tulsa, Oklahoma, United States
- Frontier Clinical Research, LLC — Smithfield, Pennsylvania, United States
- Vanderbilt Health One Hundred Oaks — Nashville, Tennessee, United States
- Gadolin Research — Beaumont, Texas, United States
- Driscoll Children's Hospital — Corpus Christi, Texas, United States
- Proactive Clinical Research LLC — Edinburg, Texas, United States
- Consano Clinical Research, LLC — Shavano Park, Texas, United States
- Victoria Clinical Research Group — Victoria, Texas, United States
- Cliniques universitaires Saint-Luc — Brussels, Belgium
- UZ Gent — Ghent, Belgium
- UZ Leuven — Leuven, Belgium
- Instituto de Pesquisa clinica de Campinas — Campinas, Brazil
- Centro de Pesquisa Sao Lucas — Campinas, Brazil
- Cendi - Endocrinologia e Diabetes — Goiânia, Brazil
- Instituto Méderi de Pesquisa e Saúde — Passo Fundo, Brazil
- Instituto da Crianca com Diabetes — Porto Alegre, Brazil
- Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology — Sacramento, California, United States
Full record on ClinicalTrials.gov
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