Study S002128

A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J)

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT06010004
Acronym: ACHIEVE-J
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 401
Start: 2023-09-28
Primary completion: 2025-06-05
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes
Interventions: DRUG:Orforglipron
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:J2A-JE-GZPE

Registered primary outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Baseline to Week 54]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0008978	Long-term safety of oral orforglipron in Japanese participants with type 2 diabetes (ACHIEVE-J): a multicentre, randomised, open-label, parallel-group phase 3 trial. Yabe D, The lancet. Diabetes & endocrinology	2026	Randomized trial	PMID 42607698 DOI	cites ClinicalTrials.gov:NCT06010004; registry reference DERIVED:42607698