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

ClinicalTrials.gov ID

NCT07668336

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

170Estimated

Last Update Posted

Aug 19, 2026Actual

Start Date

Sep 2026Estimated

Primary Completion Date

Mar 2030Estimated

Completion Date

Mar 2030Estimated

Official Title

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

Brief 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.

• Diabetes Mellitus, Type 2

• Orforglipron
• Dulaglutide

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

8589668940

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528113578379

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0151 228 4811

07906985674

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