RecruitingPhase 1Phase 2NCT06783309

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

Sponsor

COUR Pharmaceutical Development Company, Inc.

Enrollment

72 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes Type 1 Diabetes Mellitus Type 1 Diabetes Mellitis 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 Patients

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).

Eligibility

Min Age: 12 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CNP-103, a new investigational drug, in adolescents and young adults aged 12–35 who were recently diagnosed with Stage 3 Type 1 diabetes (T1D). Stage 3 means the immune system has already begun destroying insulin-producing cells and blood sugar is rising. CNP-103 aims to slow or stop this immune attack. **You may be eligible if...** - You are between 12 and 35 years old - You were diagnosed with Stage 3 Type 1 diabetes within the past 180 days - You are already on insulin therapy and standard diabetes care - Your pancreas still produces some insulin (confirmed by a C-peptide test ≥ 0.2 nmol/L) - You are not pregnant or breastfeeding **You may NOT be eligible if...** - Your diabetes was diagnosed more than 6 months ago - You have no remaining insulin production - You are currently taking systemic corticosteroids or other immune-modifying medications (without a washout period) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCNP-103

CNP-103

DRUGPlacebo

0.9% sodium chloride for injection

Locations(31)

Wake Research - Tucson

Tucson, Arizona, United States

Long Beach Clinical Trials, Inc

Long Beach, California, United States

Rady Children's Hospital San Diego

San Diego, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States

University of Florida

Gainesville, Florida, United States

University of Miami

Miami, Florida, United States

DY Professional Research Center

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Riley Hospital for Children- Indiana University

Indianapolis, Indiana, United States

Barry J. Reiner, MD, LLC

Baltimore, Maryland, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

UBMD Pediatrics - University of Buffalo

Buffalo, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

MainStreet Health

Syosset, New York, United States

Duke University

Durham, North Carolina, United States

Physicians East, PA

Greenville, North Carolina, United States

Wake Research - Raleigh

Raleigh, North Carolina, United States

Superior Clinical Research

Smithfield, North Carolina, United States

Texas Diabetes & Endocrinology

Austin, Texas, United States

Revival Research Institute - Dallas

Dallas, Texas, United States

M3 Wake Research - Dallas

Dallas, Texas, United States

Revival Research Institute - Denton

Denton, Texas, United States

Zillan Clinical Research

Houston, Texas, United States

Accurate Clinical Research, Inc

Humble, Texas, United States

Diabetes & Glandular Disease (DGD) Clinic, P.A.

San Antonio, Texas, United States

University of Washington Diabetes Institute

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06783309

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