CNP-103 clinical trial in type 1 diabetes (T1D)
The purpose of this study is to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103, an investigational treatment for T1D. Participants will receive either CNP-103 or a placebo through an intravenous (IV) infusion on Day 1, Day 8, and Day 90.
A participant will be involved in the study for approximately 208 days, which includes screening (up to 28 days), active study participation (approximately 90 days), and a follow-up period.
Key inclusion requirements:
- Aged 12-35 years
- Diagnosed with Stage 3 type 1 diabetes within the past 180 days (based on ADA guidelines)
Key exclusion requirements:
- Subjects who have used the following medications:
- Within 5 half-lives or 90 days prior to first dose, whichever is shorter:
- Oral immunomodulators: (i.e., cyclosporin, azathioprine, methotrexate)
- B cell depleting immunotherapy (e.g., Rituximab)
- Other anti-diabetic agents besides insulin (e.g., Verapamil). Insulin is allowed if on a stable dose for 30 days prior to the Day 1 dose)
- Within 6 months prior to first dose: T cell modifying immunotherapy (e.g., Abatacept, Etanercept, Ustekinumab) within 6 months prior to the first dose
- Within 12 months prior to first dose: T cell depleting immunotherapy (e.g., Teplizumab) within 12 months prior to the first dose
- Exclusion of additional immunomodulation will be at the discretion of the medical monitor and study site Investigator
- Within 5 half-lives or 90 days prior to first dose, whichever is shorter:
- Subjects who present with diabetic ketoacidosis (DKA) at the time of diagnosis. Note: any MMTT must be performed no sooner than 2 weeks and up to 4 weeks after DKA diagnosis
Learn more about this study.
Find a study location near you
How many participants are being enrolled?
Approximately 72 participants across 40 centers in the US and Canada.
Are placebos part of the clinical trial?
Yes, participants will receive an infusion of either CNP-103 therapy or placebo (salt water).
How long is participation in the clinical trial?
~208 days: including screening, active study participation, and follow-up period. After completion of the trial, participants will be provided information on participation in a long-term follow-up study for an additional 1 year.