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NCT Number: NCT04786262

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Impaired Hypoglycemic Awareness Metabolic Diseases Nutritional and Metabolic Diseases Severe Hypoglycemia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta, Edmonton, Edmonton, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VX-880

Biological

Infused into the hepatic portal vein.

Other names: Zimislecel, Formerly known as STx-02

Primary outcomes

  1. 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 (up to 5 years)

  2. 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

Secondary outcomes

  1. Parts B and C: Proportion of Participants who are Insulin Independent

    Time frame: At 1 year after VX-880 infusion

  2. Parts B and C: Proportion of Participants Free from SHEs with a Glycosylated Hemoglobin (HbA1c) less than (<) 7.0%

    Time frame: At 1 year after VX-880 infusion

  3. Parts B and C: Change From Baseline in Glycosylated Hemoglobin (HbA1c)

    Time frame: At 1 year after VX-880 infusion

  4. 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 (up to 5 years)

  5. Parts B and C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)

    Time frame: From Signing of informed consent to end of study (up to 5 years)

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Information

CONTACT

[email protected]

617-341-6777

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2030
First posted
Mar 8, 2021
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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