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

NCT07668336

Not Yet RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Diabetes Mellitus, Type 2

Interventions: Orforglipron, Dulaglutide

Countries: United States, Belgium, Brazil, India, Italy, Japan, Mexico, South Korea

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 overview

Sex: ALL

Age: 10 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (71)
  • Sacramento, California, United States
  • San Diego, California, United States
  • Stamford, Connecticut, United States
  • Atlanta, Georgia, United States
  • Decatur, Georgia, United States
  • Ammon, Idaho, United States
  • Topeka, Kansas, United States
  • Syracuse, New York, United States
  • The Bronx, New York, United States
  • Tulsa, Oklahoma, United States
  • Smithfield, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Beaumont, Texas, United States
  • Corpus Christi, Texas, United States
  • Edinburg, Texas, United States
  • Shavano Park, Texas, United States
  • Victoria, Texas, United States
  • Brussels, Belgium
  • Ghent, Belgium
  • Leuven, Belgium
  • Campinas, Brazil
  • Campinas, Brazil
  • Goiânia, Brazil
  • Passo Fundo, Brazil
  • Porto Alegre, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • Ahmedabad, India
  • Ahmedabad, India
  • Aligarh, India
  • + 41 more on CT.gov