Study S002191

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

ClinicalTrials.gov record

Registration

Registration: NCT07668336
Acronym: ACHIEVE-PEDS
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: NOT_YET_RECRUITING
Enrollment: 170
Start: 2026-09
Primary completion: 2030-03
Lead sponsor: Eli Lilly and Company
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Orforglipron; DRUG:Dulaglutide
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:J2A-MC-GZGY; CTIS:2025-524811-35-00; NIH:2025

Registered primary outcomes

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

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