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

NCT06783309 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-05-04

No results posted yet for this 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).

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

DRUG

CNP-103

CNP-103

DRUG

Placebo

0.9% sodium chloride for injection

Sponsors & Collaborators

  • COUR Pharmaceutical Development Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Peloso, MD · COUR Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-12
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06783309 on ClinicalTrials.gov