NCT06783309

CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)

A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 With Recent Onset Stage 3 Type 1 Diabetes

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: COUR Pharmaceutical Development Company, Inc. · Industry
• Sex: All
• Age: 12 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103. The approximately 393-days study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (275 days).

Conditions

• Type 1 Diabetes Mellitus
• T1D
• T1DM
• T1DM - Type 1 Diabetes Mellitus
• Type 1 Diabetes in Adolescence
• Type 1 Diabetes in Children
• Type 1 Diabetes (Juvenile Onset)
• Type 1 Diabetes
• Type 1 Diabetes Patients
• Type 1 Diabetes Mellitis

Interventions

Type	Name	Description
DRUG	CNP-103	CNP-103
DRUG	Placebo	0.9% sodium chloride for injection

Timeline

• Start date: 2025-05-12
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2025-01-20
• Last updated: 2026-03-10

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study