Orforglipron vs. dulaglutide in kids with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, phase 3 study compares the oral GLP-1 receptor agonist orforglipron to the injectable dulaglutide in participants aged 10 to under 18 with type 2 diabetes. The trial focuses on how well the medicines lower blood glucose, their safety, and how the body handles the drugs over about 61 weeks. Eligible participants typically have diabetes managed with diet, exercise, metformin and/or basal insulin, and meet specific weight and HbA1c criteria. Exclusion criteria include prior type 1 diabetes, certain complications, and prior weight-loss–promoting medications. Conducted at multiple pediatric endocrinology centers in California, Connecticut, and San Diego, the study is sponsored by Eli Lilly with no listed collaborators.

Why it matters

Who can join: the full rules

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

Where it's running

• Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
  Sacramento, California, United States Recruiting
• Stamford Therapeutics Consortium
  Stamford, Connecticut, United States Recruiting
• CenExel iResearch, LLC
  Decatur, Georgia, United States Recruiting
• Medical Research Partners
  Ammon, Idaho, United States Recruiting
• Cotton O'Neil Diabetes & Endocrinology
  Topeka, Kansas, United States Recruiting
• Advantage Clinical Trials
  The Bronx, New York, United States Recruiting

+21 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.