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

Lilly

Status and phase: Begins enrollment in 2 months; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Orforglipron; Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07668336

2025-524811-35-00 (EU Trial (CTIS) Number)

18654

J2A-MC-GZGY (Other Identifier)

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: 170 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy 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: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Orforglipron

Experimental group

Description:

Participants will receive orforglipron orally

Treatment:

Drug: Orforglipron

Dulaglutide

Active Comparator group

Description:

Participants will receive dulaglutide subcutaneously (SC)

Treatment:

Drug: Dulaglutide