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

Vertex Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Diabetes Mellitus, Type 1; Impaired Hypoglycemic Awareness; Severe Hypoglycemia

Treatments: Biological: VX-880

Study type: Interventional

Funder types: Industry

Identifiers

NCT04786262

VX20-880-101

2024-513929-23-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Clinical history of T1D with > 5 years of duration of insulin dependence
• At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment
• Stable diabetic treatment
• Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study

Key Exclusion Criteria:

• Prior islet cell transplant, organ transplant, or cell therapy

Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

VX-880

Experimental group

Treatment:

Biological: VX-880