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

Phase 1

Recruiting

• 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; Drug: Placebo

• Registration Number: NCT06783309
• Lead Sponsor: COUR Pharmaceutical Development Company, Inc.

Brief 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 208-day study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (90 days).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Study Start: 2025-05-12
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-17
• Last Update Posted: 2025-09-18
• Primary Completion: 2026-12
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
2. Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive.
3. Documented diagnosis of T1D within 180 days prior to study enrollment according to at least 1 of the American Diabetes Association [ADA] criteria.
4. Participants must be on standard of care diabetes management (e.g., insulin therapy, a nutrition plan, regular exercise, or other relevant specialty care).
5. Participants with a peak stimulated C-peptide of >0.2 nmol/L measured from a mixed meal tolerance test (MMTT). Note: this test result may be obtained from an MMTT conducted within 1 month of planned first dose.
6. Participants with an episode of diabetic ketoacidosis (DKA) must have a MMTT performed no sooner than 2 weeks and up to 4 weeks after resolution of the DKA event to have a qualifying C-peptide reading.
7. Participants on systemic corticosteroids or any medication used to treat the symptoms of T1D must undergo a washout period of at least two weeks prior to enrollment and must agree to use a non-steroid alternative throughout the trial, if necessary, for any disorder requiring corticosteroids. In addition, participants must be on a stable dose of any other medications, other than insulin, for a minimum of 1 month prior to enrollment and must agree not to increase their dose from the Screening Visit through the End of Study Visit unless reviewed and approved by the medical monitor and the principal investigator.

Exclusion Criteria

1. Participants who have used the following medications:

   a. Within 5 half-lives or 90 days prior to first dose, whichever is shorter:

   • Oral immunomodulators (e.g., cyclosporin, azathioprine, methotrexate)
   • B cell depleting immunotherapy (e.g., Rituximab)

2. Other anti-diabetic agents besides insulin (e.g., Verapamil).

3. Within 6 months prior to first dose:

   a. T cell modifying immunotherapy (e.g., Abatacept, Etanercept, Ustekinumab)

4. Within 12 months prior to first dose:

   a. T cell depleting immunotherapy (e.g., Teplizumab)

5. Exclusion of additional immunomodulation will be at the discretion of the medical monitor and study site Investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adult Cohort 1 (100 mg CNP-103)	CNP-103	Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90
Adult Cohort 1 (100 mg CNP-103)	Placebo	Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90
Adult Cohort 2 (300 mg CNP-103)	CNP-103	Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90
Adult Cohort 2 (300 mg CNP-103)	Placebo	Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90
Adult Cohort 3 (600 mg CNP-103)	CNP-103	Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90
Adult Cohort 3 (600 mg CNP-103)	Placebo	Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90
Adolescent Cohort 1 (100 mg CNP-103)	CNP-103	Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90
Adolescent Cohort 1 (100 mg CNP-103)	Placebo	Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90
Adolescent Cohort 2 (300 mg CNP-103)	CNP-103	Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90
Adolescent Cohort 2 (300 mg CNP-103)	Placebo	Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90
Adolescent Cohort 3 (600 mg CNP-103)	CNP-103	Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90
Adolescent Cohort 3 (600 mg CNP-103)	Placebo	Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90
Expansion Cohort	CNP-103	Dosing for the Expansion Cohort will be determined from Escalation Phase results
Expansion Cohort	Placebo	Dosing for the Expansion Cohort will be determined from Escalation Phase results

Primary Outcome Measures

Name	Time	Method
Safety	Day 1 Through Day 180	Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs), MedDRA 23.0 (CTCAE v. 5.0) or current
Immune Safety	Day 1 Through Day 180	Serum Cytokines: IL-1β, TNF-α, IL-6, MCP-1, MIP-1α, IFN-γ, IL-4, IL-10

Trial Locations

Locations (18)

Wake Research - Tucson; 🇺🇸 Tucson, Arizona, United States

Long Beach Clinical Trials, Inc; 🇺🇸 Long Beach, California, United States

Diablo Clinical Research; 🇺🇸 Walnut Creek, California, United States

Barbara Davis Center for Childhood Diabetes; 🇺🇸 Aurora, Colorado, United States

DY Professional Research Center; 🇺🇸 Miami, Florida, United States

Barry J. Reiner, MD, LLC; 🇺🇸 Baltimore, Maryland, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

MainStreet Health; 🇺🇸 Syosset, New York, United States

Physicians East, PA; 🇺🇸 Greenville, North Carolina, United States

Wake Research - Raleigh; 🇺🇸 Raleigh, North Carolina, United States

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