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
Eli Lilly and Company
Summary
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.
Eligibility
- Age range
- 10–17 years
- Sex
- All
- Healthy volunteers
- No
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 gallb…