A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone

NCT05971940 ↗

Phase 3 Completed 559 enrolled Eli Lilly and Company

RandomizedParallel-groupDouble-blindTreatment

Summary

The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.

Timeline

Start: 2023-08-09
Primary completion: 2025-04-03
Completion: 2025-04-03

Outcome

Met primary endpoint

paper All three doses of orforglipron were superior to placebo with respect to the primary end point; PMID 40544435 ↗

registry analysis (superiority test); Placebo vs 3 mg Orforglipron; p <.001; Least Square (LS) Mean Difference (Net) -1.12 (95% CI -1.43 to -0.80); Mixed Models Analysis NCT05971940 ↗

Publications

Rosenstock J, Hsia S, Nevarez Ruiz L, Eyde S, Cox D, Wu WS, Liu R, Li J, Fernandez Lando L, Denning M, Ludwig L, Chen Y; ACHIEVE-1 Trial Investigators. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes. N Engl J Med. 2025 Sep 18;393(11):1065-1076. doi: 10.1056/NEJMoa2505669. Epub 2025 Jun 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Orforglipron	Small molecule	3 mg	Oral
Subject	Orforglipron	Small molecule	12 mg	Oral
Subject	Orforglipron	Small molecule	36 mg	Oral