A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes
Vertex Pharmaceuticals Incorporated · NCT04786262
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–65 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 57
- US sites recruiting
- 10
- Study start
- March 29, 2021
- Record last updated
- September 1, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: VX-880; VX-017
Conditions: Diabetes Mellitus, Type 1; Impaired Hypoglycemic Awareness; Severe Hypoglycemia
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
City of Hope
Duarte, CA 91010
University of California San Francisco
San Francisco, CA 94143
UHealth Diabetes Research Institute
Miami, FL 33136
University of Chicago
Chicago, IL 60637
Massachusetts General Hospital
Boston, MA 02114
Hospital of the University of Pennsylvania
Philadelphia, PA 19104
University of Pittsburgh Medical Center Montefiore
Pittsburgh, PA 15213
Baylor Scott and White Research Institute
Dallas, TX 75246
VCU Medical Center, Richmond
Richmond, VA 23298
University of Wisconsin
Madison, WI 53792
Study contacts (from the official record)
- Medical Information · 617-341-6777 · medicalinfo@vrtx.com
Similar studies in California
All diabetes studies in California →- RecruitingHealthy volunteersPhase 1Overnight stay mentioned
A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
AstraZeneca
- Location
- Glendale, CA + 1 other US site
- Eligibility basics
- Ages 18–55
- RecruitingHealthy volunteersPhase 1
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
TIXiMED, Inc.
- Location
- Chula Vista, CA
- Eligibility basics
- Ages 18–70
- RecruitingHealthy volunteersPhase 1
Safety and Drug Concentrations of REGN20934 in Adults With Overweight or Obesity
Regeneron Pharmaceuticals
- Location
- Glendale, CA
- Eligibility basics
- Ages 18–65
- RecruitingHealthy volunteersPhase 1
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of…
AstraZeneca
- Location
- Glendale, CA + 3 other US sites
- Eligibility basics
- Ages 18–75