A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

Summary

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.

Timeline

Start

2023-11-10

Primary completion

2025-09-15

Completion

2025-09-15

Outcome

Met primary endpoint

paper Each dosage of orforglipron was superior to placebo PMID 42251769 ↗

paper 12 mg once daily, -1.08% [95% CI, -1.33% to -0.83%]; 36 mg once daily, -1.03% [95% CI, -1.28% to -0.77%]; P < .001 for all PMID 42251769 ↗

release “ACHIEVE-5, orforglipron lowered A1C by an additional 2.1% when taken with insulin glargine, meeting the primary endpoint” lilly.com ↗

Publications

• Giorgino F, D'Souza S, Ludwig L, Kiyosue A, Ibriga H, Rha H, Denning M, Wu WS, Fernandez Lando L, Tobian J. Orforglipron Added to Titrated Insulin Glargine in Type 2 Diabetes: The ACHIEVE-5 Randomized Clinical Trial. JAMA. 2026 Aug 4;336(5):389-399. doi: 10.1001/jama.2026.9512.

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

Indications