Study S001044

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT06109311
Acronym: ACHIEVE-5
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 546
Start: 2023-11-10
Primary completion: 2025-09-15
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes
Interventions: DRUG:Orforglipron; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:J2A-MC-GZGW; OTHER:U1111-1294-2797; OTHER:2023-507280-18-00; NIH:2023

Registered primary outcomes

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

Linked records (2)

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
R0003798	Orforglipron Added to Titrated Insulin Glargine in Type 2 Diabetes: The ACHIEVE-5 Randomized Clinical Trial. Giorgino F, JAMA	2026	Randomized trial	PMID 42251769 DOI	cites ClinicalTrials.gov:NCT06109311; registry reference DERIVED:42251769
R0039726	1253-OR: ADA Presidents' Select Abstract: Efficacy and Safety of Orforglipron vs. Placebo Added to Titrated Insulin Glargine in Adults with Long-Standing Type 2 Diabetes: ACHIEVE-5 FRANCESCO GIORGINO, Diabetes	2026	Randomized trial	DOI	cites ClinicalTrials.gov:NCT06109311