RightFit
Not yet recruitingPhase 3

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

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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares orforglipron with dulaglutide in children ages 10 to 17 with type 2 diabetes. It checks how well the medicines work, how safe they are, and how the body processes them. Taking part lasts about 61 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 10 to 17 years old.
  • Have type 2 diabetes treated with diet and exercise, plus metformin, basal insulin (long-acting insulin), or both.
  • Have an HbA1c above 6.5% and no higher than 11.0% at screening. This blood test measures average blood sugar.
  • Weigh at least 50 kilograms (110 pounds) and have a body mass index (BMI) above the 85th percentile. BMI compares weight with height; this cutoff is higher than that of 85 out of 100 children of the same age and sex.

Who can't join

  • Have type 1 diabetes.
  • Have had diabetic ketoacidosis (dangerous acid buildup in the blood) or hyperosmolar syndrome (very high blood sugar with severe loss of body fluids) since the type 2 diabetes diagnosis.
  • In the 6 months before screening, have had severe low blood sugar or low blood sugar without noticing warning signs.
  • Have had pancreatitis (swelling of the pancreas) or gallbladder disease.
  • You or a family member have had medullary thyroid carcinoma (a type of thyroid cancer) or MEN2 (a condition that causes tumors in glands that make hormones).
  • In the 90 days before screening, have used blood sugar medicines other than metformin, basal insulin, or SGLT2 inhibitors.
  • In the 90 days before screening, have used prescription or over-the-counter medicines that promote weight loss.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (17)

CA

CT

GA

ID

KS

NY

OK

PA

TN

TX