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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 (J2A-MC-GZGY)

A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes (J2A-MC-GZGY)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Recruiting

June. 29, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- 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

- 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

Both

Diabetes Mellitus, Type 2

DRUG: Orforglipron(Other Name: LY3502970)
Administered orally
DRUG: Dulaglutide(Other Name: LY2189265)
Administered SC

(Study Arms)
Experimental: Orforglipron
Participants will receive orforglipron orally
Interventions:
Drug: Orforglipron
Active Comparator: Dulaglutide
Participants will receive dulaglutide subcutaneously (SC)
Interventions:
Drug: Dulaglutide

Change from Baseline in Hemoglobin A1c (HbA1c) [Time Frame: Baseline, Week 40]

+81-3-6665-0572

June. 22, 2026

Yes

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

United States/Belgium/Brazil/India/Italy/Mexico/South Korea/Spain/Taiwan/United Kingdom