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NCT Number: NCT07668336

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cliniques universitaires Saint-Luc, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orforglipron

Drug

Administered orally

Other names: LY3502970

Dulaglutide

Drug

Administered SC

Other names: LY2189265

Primary outcomes

  1. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 40

Secondary outcomes

  1. Change from Baseline in HbA1c

    Time frame: Baseline, Week 52

  2. Percentage of Participants with HbA1c ≤6.5%

    Time frame: Week 40

  3. Percent Change from Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 40

  4. Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL

    Time frame: Baseline, during 2 weeks prior to Week 40

  5. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 40

  6. Change from Baseline in Blood Pressure

    Time frame: Baseline, Week 40

  7. Percent Change from Baseline in Total Cholesterol

    Time frame: Baseline, Week 40

  8. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 40

  9. Change from Baseline in Tanner Staging

    Time frame: Baseline, Week 52

  10. Change from Baseline in Homeostatic Model Assessment of Beta-cell (HOMA2-B)

    Time frame: Baseline, Week 40

  11. Change from Baseline in the EQ-5D-Y-5L

    Time frame: Baseline, Week 40

  12. Number of Participants by Acceptability Response Category

    Time frame: Baseline, Week 52

  13. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Orforglipron

    Time frame: Predose through Week 30

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: ACHIEVE-PEDS

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 25, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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