CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)
NCT ID: NCT06783309
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
72 participants
INTERVENTIONAL
2025-05-12
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
The Expansion Phase will follow, enrolling approximately 36 subjects at the safe and tolerated dose(s) identified during the Escalation Phase. Subjects in this phase will be randomized 3:1 to receive either CNP-103 or placebo (0.9% Sodium Chloride Injection, USP).
TREATMENT
DOUBLE
Study Groups
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Adult Cohort 1 (100 mg CNP-103)
Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90
CNP-103
CNP-103
Placebo
0.9% sodium chloride for injection
Adult Cohort 2 (300 mg CNP-103)
Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90
CNP-103
CNP-103
Placebo
0.9% sodium chloride for injection
Adult Cohort 3 (600 mg CNP-103)
Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90
CNP-103
CNP-103
Placebo
0.9% sodium chloride for injection
Adolescent Cohort 1 (100 mg CNP-103)
Three (3) IV administrations of CNP-103 (100 mg) on Days 1, 8, and 90
CNP-103
CNP-103
Placebo
0.9% sodium chloride for injection
Adolescent Cohort 2 (300 mg CNP-103)
Three (3) IV administrations of CNP-103 (300 mg) on Days 1, 8, and 90
CNP-103
CNP-103
Placebo
0.9% sodium chloride for injection
Adolescent Cohort 3 (600 mg CNP-103)
Three (3) IV administrations of CNP-103 (600 mg) on Days 1, 8, and 90
CNP-103
CNP-103
Placebo
0.9% sodium chloride for injection
Expansion Cohort
Dosing for the Expansion Cohort will be determined from Escalation Phase results
CNP-103
CNP-103
Placebo
0.9% sodium chloride for injection
Interventions
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CNP-103
CNP-103
Placebo
0.9% sodium chloride for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
35 Years
ALL
No
Sponsors
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COUR Pharmaceutical Development Company, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Peloso, MD
Role: STUDY_DIRECTOR
COUR Pharma
Locations
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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
University of Florida
Gainesville, Florida, United States
DY Professional Research Center
Miami, Florida, United States
University of South Florida
Tampa, Florida, 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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CNP-103-CL-201
Identifier Type: -
Identifier Source: org_study_id