ACHIEVE-PEDS

Not yet recruitingPhase 3

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

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

Lead sponsor

Eli Lilly and Company

Assets

Dulaglutide / Orforglipron

Listed sites

Recruiting sites

Estimated enrollment

170

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•HbA1c 6.5-11%•Age 10-17

Primary endpoint

•Hemoglobin A1c (HbA1c)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07668336

Org study ID18654

Secondary ID2025-524811-35-00

Secondary IDJ2A-MC-GZGYEli Lilly and Company

Timeline

Milestones

Study first posted2026-06-25actual

Last update posted2026-06-25actual

Study start2026-09estimated (month precision)

Primary completion2030-03estimated (month precision)

Study completion2030-03estimated (month precision)

Assets

Investigational agents

Dulaglutide Orforglipron

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age10 Years

Maximum age17 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Other (unclassified)

Cardiometabolic biomarkers

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Percent Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 40

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 40

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 40

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 40

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in HbA1c

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants with HbA1c ≤6.5%

Time frame:Week 40

threshold achievement, improvement

Secondary/protocol endpoint

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

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

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Blood Pressure

Time frame:Baseline, Week 40

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Total Cholesterol

Time frame:Baseline, Week 40

percent change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

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

Time frame:Baseline, Week 40

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

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

Time frame:Predose through Week 30

concentration, descriptive

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Change from Baseline in Tanner Staging

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, Week 40

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of Participants by Acceptability Response Category

Time frame:Baseline, Week 52

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.