A Phase 3 interventional study of VX-880 and VX-017 in Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness and Severe Hypoglycemia, sponsored by Vertex Pharmaceuticals Incorporated. Recruiting at 29 sites in 10 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Vertex Pharmaceuticals Incorporated · Phase 3, Interventional, and Treatment
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 57 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Vertex Pharmaceuticals Incorporated is the lead sponsor of 249 studies on the registry; 17 are open to participants now.
Of its 106 completed or terminated interventional studies of FDA-regulated products, 53 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
-Prior islet cell transplant, organ transplant, or cell therapy
Other protocol-defined Inclusion/Exclusion criteria may apply
Biological: VX-880
Biological: VX-017
Infused into the hepatic portal vein.
Also known as: Zimislecel, Formerly known as STx-02
Infused into the hepatic portal vein.
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)
Time frame: From VX-880 infusion to end of study (at least 5 years)
Parts B and C: Proportion of Participants who are Insulin Independent with Absence of Severe Hypoglycemic Events (SHEs)
Time frame: 1 year after achieving insulin independence (following VX-880 infusion)
Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)
Time frame: From VX-017 infusion to end of study (at least 5 years)
Parts B and C: Proportion of Participants who are Insulin Independent
Time frame: At 1 year after VX-880 infusion
Parts B and C: Proportion of Participants Free from SHEs with a Glycated Hemoglobin (HbA1c) less than (<) 7.0%
Time frame: SHEs: from Day 90 through 1 year (inclusive) after VX-880 infusion; HbA1c < 7% at 1 year after VX-880 infusion
Parts B and C: Change From Baseline in Glycated Hemoglobin (HbA1c)
Time frame: At 1 year after VX-880 infusion
Parts B and C: Proportion of Participants Who Maintain Insulin Independence for at least 1 year
Time frame: From VX-880 infusion to end of study (at least 5 years)
Parts B and C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)
Time frame: From VX-880 infusion up to end of study (at least 5 years)
Part D: Change from baseline in peak C-peptide during mixed-meal tolerance test (MMTT)
Time frame: At Day 90 after VX-017 infusion
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Plan to share: No — Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
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Vertex Pharmaceuticals Incorporated →