Actively Recruiting
CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)
Led by COUR Pharmaceutical Development Company, Inc. · Updated on 2026-05-04
72
Participants Needed
28
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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 393-days study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (275 days).
CONDITIONS
Official Title
CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent and privacy authorization
- Male or non-pregnant, non-breastfeeding female aged 12 to 35 years
- Diagnosed with Stage 3 Type 1 Diabetes within 180 days before enrollment, per ADA criteria
- Using standard diabetes care including insulin therapy, nutrition, and exercise
- Peak stimulated C-peptide greater than 0.2 nmol/L from a screening mixed meal tolerance test
- If diabetic ketoacidosis occurred, MMTT done at least 2 weeks after resolution with qualifying C-peptide
- On stable dose of non-insulin medications for at least 1 month before enrollment and agree not to increase dose without approval
- Female participants of non-childbearing potential or women agreeing to use highly effective birth control and not become pregnant during study
- Female participants agree not to breastfeed or donate ova during study
- Male participants with partners of childbearing potential agree to use effective birth control during study
- Weight over 35 kg for cohorts 1 and 2; over 50 kg for cohort 3
- BMI Z-Score between 5th and 95th percentile for ages 12-17; BMI 18.0-30.0 (not inclusive) for ages 18-35
You will not qualify if you...
- Unable to comply with prohibited medication guidelines
- History of tuberculosis or positive Quantiferon test
- Vaccinated with live vaccine within 28 days before screening
- Vaccinated with subunit vaccine or COVID-19 vaccine within 14 days before screening
- Planned vaccinations during screening through Day 90 plus 1 week (except annual flu vaccine)
- Known or suspected acute infection including COVID-19 at or within 2 weeks before screening
- Abnormal screening labs deemed clinically significant
- Positive tests for hepatitis B, hepatitis C, or HIV at screening
- History or active immune disorders other than Type 1 Diabetes unless approved by Medical Monitor
- Significant cardiovascular disease in past 12 months
- History or current malignant tumors except certain skin cancers
- Unlikely to adhere to study visits and procedures
- Received investigational therapy other than CNP-103 within 28 days or 5 half-lives prior to screening
- Any active condition making participation unsuitable per Investigator
- Known sensitivity to any components of CNP-103
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 28 locations
1
Wake Research - Tucson
Tucson, Arizona, United States, 85710
Actively Recruiting
2
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
Actively Recruiting
3
Diablo Clinical Research
Walnut Creek, California, United States, 94598
Actively Recruiting
4
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
Actively Recruiting
5
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
6
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
7
DY Professional Research Center
Miami, Florida, United States, 33176
Actively Recruiting
8
University of South Florida
Tampa, Florida, United States, 33612
Actively Recruiting
9
Atlanta Diabetes Association
Atlanta, Georgia, United States, 30318
Actively Recruiting
10
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
11
Riley Hospital for Children- Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
12
Barry J. Reiner, MD, LLC
Baltimore, Maryland, United States, 21229
Actively Recruiting
13
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
14
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Actively Recruiting
15
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
16
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
17
UBMD Pediatrics - University of Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
18
MainStreet Health
Syosset, New York, United States, 11791
Actively Recruiting
19
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
20
Physicians East, PA
Greenville, North Carolina, United States, 27834
Actively Recruiting
21
Wake Research - Raleigh
Raleigh, North Carolina, United States, 27612
Actively Recruiting
22
Superior Clinical Research
Smithfield, North Carolina, United States, 27577
Actively Recruiting
23
Texas Diabetes & Endocrinology
Austin, Texas, United States, 78749
Actively Recruiting
24
M3 Wake Research - Dallas
Dallas, Texas, United States, 75246
Actively Recruiting
25
Accurate Clinical Research, Inc
Humble, Texas, United States, 77346
Actively Recruiting
26
Diabetes & Glandular Disease (DGD) Clinic, P.A.
San Antonio, Texas, United States, 78229
Actively Recruiting
27
TopLine Clinical, Inc
Waxahachie, Texas, United States, 75165
Actively Recruiting
28
University of Washington Diabetes Institute
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
S
Stephanie Slaughter
CONTACT
C
Cristina Varela
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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