NCT04786262

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

Conditions

• Diabetes Mellitus, Type 1
• Impaired Hypoglycemic Awareness
• Severe Hypoglycemia

Interventions

Type	Name	Description
BIOLOGICAL	VX-880	Infused into the hepatic portal vein.

Timeline

• Start date: 2021-03-29
• Primary completion: 2027-06-30
• Completion: 2030-06-30
• First posted: 2021-03-08
• Last updated: 2026-03-17

Locations

29 sites across 10 countries: United States, Canada, France, Germany, Italy, Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study