NCT06109311

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 546 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Orforglipron	Administered orally.
DRUG	Placebo	Administered orally.

Timeline

• Start date: 2023-11-10
• Primary completion: 2025-09-15
• Completion: 2025-09-15
• First posted: 2023-10-31
• Last updated: 2025-10-20

Locations

70 sites across 6 countries: United States, Brazil, China, Japan, Puerto Rico, Romania

Regulatory

• FDA-regulated drug study