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CNP-103 in Recent Onset Stage 3 Type 1 Diabetes
NCT06783309Phase 2
Key facts
- Status
- Recruiting
- Start
- May 2025
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- COUR Pharmaceuticals
- Modality
- Polymer-based Nanoparticles, Recombinant Proteins and Enzymes
- Drugs
- CNP-103
- Conditions
- type 1 diabetes mellitus (T1D)
01
Overview
Phase 2, randomised, double-blind trial of CNP-103 in type 1 diabetes mellitus (T1D) (7 cohorts), sponsored by COUR Pharmaceuticals. Primary endpoints: Safety at 1 year and Immune Safety at 1 year. Started May 2025; status: recruiting.
02
Design
7 arms- Study design
- RandomizedDouble-blind
Adult Cohort 1 (100 mg CNP-103)
Three (3) IV administrations of CNP-103 (100 mg) or Placebo on Days 1, 8, and 90
Adult Cohort 2 (300 mg CNP-103)
Three (3) IV administrations of CNP-103 (300 mg) or Placebo on Days 1, 8, and 90
Adult Cohort 3 (600 mg CNP-103)
Three (3) IV administrations of CNP-103 (600 mg) or Placebo on Days 1, 8, and 90
Adolescent Cohort 1 (100 mg CNP-103)
Three (3) IV administrations of CNP-103 (100 mg) or Placebo on Days 1, 8, and 90
Adolescent Cohort 2 (300 mg CNP-103)
Three (3) IV administrations of CNP-103 (300 mg) or Placebo on Days 1, 8, and 90
Adolescent Cohort 3 (600 mg CNP-103)
Three (3) IV administrations of CNP-103 (600 mg) or Placebo on Days 1, 8, and 90
1 more in the full profile.
03
Who it enrols
Participants aged 12-35 with a documented diagnosis of Stage 3 Type 1 Diabetes within 180 days prior to enrollment, peak stimulated C-peptide >0.2 nmol/L, and on standard of care insulin therapy. Excludes individuals with active infections, recent vaccinations, other immune disorders, significant cardiovascular disease, or a history of malignant tumors.
04
Endpoints
Primary
Safety
Immune Safety
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