NCT05463744

A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 692 (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 measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.

Conditions

• Type 1 Diabetes
• Diabetes

Interventions

Type	Name	Description
DRUG	Insulin Efsitora Alfa	Administered SC
DRUG	Insulin Degludec	Administered SC

Timeline

• Start date: 2022-08-12
• Primary completion: 2024-05-07
• Completion: 2024-05-07
• First posted: 2022-07-19
• Last updated: 2025-06-24
• Results posted: 2025-06-24

Locations

83 sites across 7 countries: United States, Argentina, Japan, Poland, Puerto Rico, Slovakia, Taiwan

Regulatory

• FDA-regulated drug study