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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)

C

COUR Pharmaceuticals

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Type 1 Diabetes Patients
Type 1 Diabetes Mellitus
Type 1 Diabetes
T1D
Type 1 Diabetes in Adolescence
T1DM
Type 1 Diabetes in Children
Type 1 Diabetes (Juvenile Onset)
Type 1 Diabetes Mellitis
T1DM - Type 1 Diabetes Mellitus

Treatments

Drug: CNP-103
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06783309
CNP-103-CL-201

Details and patient eligibility

About

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).

Enrollment

72 estimated patients

Sex

All

Ages

12 to 35 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

72 participants in 7 patient groups

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

Trial contacts and locations

20

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Central trial contact

Emily Hong; Cristina Varela

Data sourced from clinicaltrials.gov

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