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

September 9, 2026 updated by: COUR Pharmaceutical Development Company, Inc.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Recruiting
        • Wake Research - Tucson
        • Contact:
        • Principal Investigator:
          • David Alster
      • Tucson, Arizona, United States, 85716
        • Recruiting
        • Liver Institute PLLC
        • Contact:
        • Principal Investigator:
          • Neda Ebrahimi
    • California
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital
        • Contact:
        • Principal Investigator:
          • David Ahn
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital San Diego
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carla Demeterco-Berggren
      • Walnut Creek, California, United States, 94598
    • Colorado
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Recruiting
        • Southwest General Healthcare Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Orlando Fernandez
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Timothy Foster
        • Contact:
      • Hialeah, Florida, United States, 33012
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemours Children's Health
        • Principal Investigator:
          • Larry Fox
        • Contact:
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • David Baidal
        • Contact:
        • Contact:
      • Miami, Florida, United States, 33176
        • Recruiting
        • DY Professional Research Center
        • Principal Investigator:
          • Soroush Aghigh
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida
        • Principal Investigator:
          • Henry Rodriguez
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
        • Principal Investigator:
          • Michael Hughes
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Children's Healthcare of Atlanta
        • Contact:
        • Principal Investigator:
          • Kristina Cossen
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Atlanta Diabetes Association
        • Contact:
        • Principal Investigator:
          • Carson Womack
    • Idaho
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60611
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Gabriel Uwaifo
        • Contact:
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children- Indiana University
        • Contact:
        • Principal Investigator:
          • Linda DeMeglio
    • Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Joslin Diabetes Center
        • Principal Investigator:
          • Jason Gaglia
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Elif Oral
        • Contact:
      • Bloomfield Township, Michigan, United States, 48302
        • Recruiting
        • Embassy Research Network
        • Contact:
        • Principal Investigator:
          • George Grunberger
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • University of Minnesota
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antoinette Moran
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Wayne Moore
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Janet McGill
        • Contact:
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • UBMD Pediatrics - University of Buffalo
        • Contact:
        • Principal Investigator:
          • Lucy Mastrandrea
      • New York, New York, United States, 10017
        • Recruiting
        • NYU Langone Diabetes & Endocrine Associates
        • Contact:
        • Principal Investigator:
          • Ramachandra Naik
      • New York, New York, United States, 10016
        • Recruiting
        • Hassenfield Children's Hospital
        • Contact:
        • Principal Investigator:
          • Mary Gallagher
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
        • Principal Investigator:
          • Jennifer Green
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Physicians East, PA
        • Principal Investigator:
          • Mark Warren
        • Contact:
      • Raleigh, North Carolina, United States, 27612
      • Smithfield, North Carolina, United States, 27577
    • Ohio
      • Cleveland, Ohio, United States, 44106
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Recruiting
        • University Diabetes & Endocrine Consultants
        • Principal Investigator:
          • David Huffman
        • Contact:
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • Le Bonhuer Children's
        • Contact:
        • Principal Investigator:
          • Ramin Alemzadeh
    • Texas
      • Austin, Texas, United States, 78749
      • Dallas, Texas, United States, 75246
        • Recruiting
        • M3 Wake Research - Dallas
        • Contact:
        • Principal Investigator:
          • Carlos Arauz-Pacheco
      • Humble, Texas, United States, 77346
      • San Antonio, Texas, United States, 78229
      • Waxahachie, Texas, United States, 75165
        • Recruiting
        • TopLine Clinical, Inc
        • Contact:
        • Principal Investigator:
          • Stephen Mueller
    • Washington
      • Seattle, Washington, United States, 98101
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington Diabetes Institute
        • Contact:
          • Dori Khakpour
          • Phone Number: 206-945-4965
          • Email: dorik@uw.edu
        • Principal Investigator:
          • Irl Hirsch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Stage 3 T1D within 180 days prior to study enrollment according to American Diabetes Association (ADA) criteria.
  4. Participants must be on standard of care diabetes management including insulin therapy as a routine and also consisting of a nutrition plan, regular exercise, or other relevant specialty care as required on a patient-by-patient basis.
  5. Participants with a peak stimulated C-peptide of >0.2 nmol/L measured from a screening mixed meal tolerance test (MMTT).
  6. Participants with an episode of diabetic ketoacidosis (DKA) must have a MMTT performed no sooner than 2 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 (other than insulin) 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.
  8. Female participants of non-childbearing potential (e.g., surgical sterilization, no menses for a year).
  9. Women of childbearing potential (WOCBP) who have agreed not to become pregnant during the study, have a negative pregnancy test at Screening Visit, and agree to use 1 highly effective form of birth control starting at initial screening and continuing throughout the entire study to Day 365.
  10. Female participants who agree to not breastfeed starting at initial Screening and throughout the entire study to Day 365.
  11. Female participants who agree to not donate ova, including autologous, starting at initial Screening and throughout the entire study to Day 365.
  12. Male participant and with a spouse or partner of childbearing potential, who themselves and their spouse or partner agree to practice an effective form of birth control as discussed with the study doctor or study staff starting at Screening and throughout the entire study to Day 365.
  13. Participants must weigh >35 kg at Screening for Cohort 1 (100 mg) and Cohort 2 (300 mg); participants must weigh >50 kg at Screening for Cohort 3 (600 mg).

  14. Body mass index (BMI):

    1. Participants 12-17 years: BMI Z-Score within 5th and 95th percentile based on participant's age (e.g., Baylor College of Medicine Age-based Pediatric Growth Reference Charts: BMI Z-Score and Percentile Calculator)
    2. Participants 18-35 years: 18.0-30.0 (not inclusive)

Exclusion Criteria:

  1. Participants unable to comply with prohibited medication outlined in the protocol.
  2. Exclusion of additional immunomodulation will be at the discretion of the Medical Monitor and study site Investigator.
  3. Participants with a history of tuberculosis or positive Quantiferon test.

  4. Participants who received vaccinations in the following time frame:

    1. Any live vaccine within 28 days prior to Screening.
    2. Any subunit vaccine within 14 days prior to Screening.
    3. Any COVID-19 vaccine series within 14 days prior to Screening.
    4. Any other planned vaccine starting 14 days prior to Screening and through study Day 90 and 1 week after. (Note: The annual influenza vaccine is not an exclusion criterion.)
  5. Known or suspected acute infection, including COVID-19 at the time of Screening or within 2 weeks prior to Screening. After confirmed recent COVID-19 infection, a minimum of 2 weeks of recovery post-acute infection is required.
  6. Participants with Screening laboratory test results that are outside the normal limits and considered by the Investigator to be clinically significant.
  7. Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody as determined at Screening.
  8. Participants with a history of or currently active immune disorders other than T1D (including autoimmune disease) unless the condition, after discussion with the Medical Monitor, has been deemed to be acceptable for the participant's participation in this study.
  9. Participants with a clinical history of significant cardiovascular disease in the past 12 months.
  10. Participants with a complication or medical history of malignant tumor, other than basal cell or squamous cell carcinomas of the skin.
  11. Participants who, in the Investigator's opinion, will be unable to adhere to study visits and procedures.
  12. Participants who have received investigational therapy other than CNP-103 within 28 days or 5 half-lives, whichever is longer, prior to Screening.
  13. Participants with any known active condition which, in the Investigator's opinion, makes the participant unsuitable for study participation.
  14. Known sensitivity to any components of CNP-103.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adult Cohort 1 (100 mg CNP-103)
Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90
Drug: Placebo
0.9% sodium chloride for injection
Drug: CNP-103
CNP-103
Other Names:
  • Treatment
Experimental: Adult Cohort 2 (300 mg CNP-103)
Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90
Drug: Placebo
0.9% sodium chloride for injection
Drug: CNP-103
CNP-103
Other Names:
  • Treatment
Experimental: Adult Cohort 3 (600 mg CNP-103)
Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90
Drug: Placebo
0.9% sodium chloride for injection
Drug: CNP-103
CNP-103
Other Names:
  • Treatment
Experimental: Adolescent Cohort 1 (100 mg CNP-103)
Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90
Drug: Placebo
0.9% sodium chloride for injection
Drug: CNP-103
CNP-103
Other Names:
  • Treatment
Experimental: Adolescent Cohort 2 (300 mg CNP-103)
Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90
Drug: Placebo
0.9% sodium chloride for injection
Drug: CNP-103
CNP-103
Other Names:
  • Treatment
Experimental: Adolescent Cohort 3 (600 mg CNP-103)
Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90
Drug: Placebo
0.9% sodium chloride for injection
Drug: CNP-103
CNP-103
Other Names:
  • Treatment
Experimental: Expansion Cohort
Dosing for the Expansion Cohort will be determined from Escalation Phase results
Drug: Placebo
0.9% sodium chloride for injection
Drug: CNP-103
CNP-103
Other Names:
  • Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: Day 1 Through Day 365
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs), MedDRA 28.1 (CTCAE v. 5.0) or current
Day 1 Through Day 365
Immune Safety
Time Frame: Day 1 Through Day 365
Serum Cytokines: IL-1β, TNF-α, IL-6, MCP-1, MIP-1α, IFN-γ, IL-4, IL-10
Day 1 Through Day 365

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

COUR Pharmaceutical Development Company, Inc.

Investigators

  • Study Director: Paul Peloso, MD, COUR Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNP-103-CL-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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