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NCT06783309 · ClinicalTrials.gov registry record · Phase 1
CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)
A Phase 1 study of Type 1 Diabetes and Type 1 Diabetes Mellitus, sponsored by COUR Pharmaceutical Development Company.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 20
- Study locations
NCT06783309: Recruiting Phase 1 study of Type 1 Diabetes and Type 1 Diabetes Mellitus, sponsored by COUR Pharmaceutical Development Company.
NCT06783309 is a Phase 1 study of Type 1 Diabetes and Type 1 Diabetes Mellitus that is actively recruiting participants, run by COUR Pharmaceutical Development Company. The registered enrollment target is 72 participants, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06783309, a Phase 1 study of Type 1 Diabetes and Type 1 Diabetes Mellitus, is actively recruiting participants, sponsored by COUR Pharmaceutical Development Company.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs), MedDRA 28.1 (CTCAE v. 5.0) or current
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CNP-103
Study Locations (20)
Florida
- University of Florida - Gainesville
- University of Miami - Miami
- DY Professional Research Center - Miami
- University of South Florida - Tampa
California
- Long Beach Clinical Trials, Inc - Long Beach
- Rady Children's Hospital San Diego - San Diego
- Diablo Clinical Research - Walnut Creek
New York
- UBMD Pediatrics - University of Buffalo - Buffalo
- Columbia University Irving Medical Center - New York
- MainStreet Health - Syosset
Missouri
- Children's Mercy Hospital - Kansas City
- Washington University School of Medicine - St Louis
Arizona
- Wake Research - Tucson - Tucson
Colorado
- Barbara Davis Center for Childhood Diabetes - Aurora
Illinois
- Southern Illinois University School of Medicine - Springfield
Indiana
- Riley Hospital for Children- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2025-05-12 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What NCT06783309 shows while recruiting
NCT06783309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (91% lower).
The record links to 10 conditions, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06783309 names 20 study sites across 12 states, led by Florida, California, New York.
Frequently Asked Questions
What is clinical trial NCT06783309 about?
NCT06783309 is a clinical study titled "CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)". 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 Evaluat...
What is the current status of trial NCT06783309?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2025-05-12. Estimated completion is 2027-06.
What conditions does trial NCT06783309 study?
This clinical trial studies the following conditions: Type 1 Diabetes, Type 1 Diabetes Mellitus, T1D, T1DM, T1DM - Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT06783309?
The interventions under investigation include: Placebo (DRUG), CNP-103 (DRUG).
Who is sponsoring clinical trial NCT06783309?
This trial is sponsored by COUR Pharmaceutical Development Company, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06783309 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06783309's enrollment target sits among peer trials
72 67th of 198 higher than 132 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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