CNP-103 for Recently Diagnosed Type 1 Diabetes
This study is testing a drug called CNP-103 in adolescents and adults (ages 12-35) who have been recently diagnosed (within 6 months) with Stage 3 Type 1 Diabetes (T1D). Participants will receive either CNP-103 or a placebo (an inactive substance like salt water). The main goals are to check the safety of CNP-103 and how well your body tolerates it over about a year. We also want to see if it has any effect on the disease. You can join if you are between 12 and 35 years old and have a documented diagnosis of Stage 3 T1D within the last 180 days. The study is currently unclear about its recruitment status.
- Study design
- This is a Phase 1b/2a First-in-Human (FIH) interventional study with a planned enrollment of 72 participants. It compares CNP-103 to a placebo.
- What's involved
- The study lasts approximately 393 days, including a 28-day screening period, a 90-day treatment period, and 275 days of post-dose evaluations.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and immune safety from Day 1 through Day 365 after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)
At a glance
Conditions
Where it's being run
38 sites across 18 statesStudy leadership
- Paul Peloso, MD · STUDY_DIRECTOR · COUR Pharma
Who to contact
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What this trial measures
- SafetyDay 1 Through Day 365
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs), MedDRA 28.1 (CTCAE v. 5.0) or current
- Immune SafetyDay 1 Through Day 365
Serum Cytokines: IL-1β, TNF-α, IL-6, MCP-1, MIP-1α, IFN-γ, IL-4, IL-10