A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes (ACHIEVE-PEDS)
Status and phase
Conditions
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Study type
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Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
170 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Physicians interested in becoming principal investigators please contact
Data sourced from clinicaltrials.gov
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