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RecruitingPhase 1/Phase 2

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

COUR Pharmaceutical Development Company, Inc. · NCT06783309

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12–35 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
72
US sites recruiting
45
Study start
May 12, 2025
Record last updated
September 11, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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).

Being studied: CNP-103; Placebo

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
  • Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive.
  • Documented diagnosis of Stage 3 T1D within 180 days prior to study enrollment according to American Diabetes Association (ADA) criteria.
  • 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.
  • Participants with a peak stimulated C-peptide of >0.2 nmol/L measured from a screening mixed meal tolerance test (MMTT).
  • 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.
  • 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.
  • Female participants of non-childbearing potential (e.g., surgical sterilization, no menses for a year).
  • 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.
  • Female participants who agree to not breastfeed starting at initial Screening and throughout the entire study to Day 365.
  • Female participants who agree to not donate ova, including autologous, starting at initial Screening and throughout the entire study to Day 365.
  • 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.
  • 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).
  • Body mass index (BMI):
  • 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)
  • Participants 18-35 years: 18.0-30.0 (not inclusive)

Exclusion Criteria

  • Participants unable to comply with prohibited medication outlined in the protocol.
  • Exclusion of additional immunomodulation will be at the discretion of the Medical Monitor and study site Investigator.
  • Participants with a history of tuberculosis or positive Quantiferon test.
  • Participants who received vaccinations in the following time frame:
  • Any live vaccine within 28 days prior to Screening.
  • Any subunit vaccine within 14 days prior to Screening.
  • Any COVID-19 vaccine series within 14 days prior to Screening.
  • 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.)
  • 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.
  • Participants with Screening laboratory test results that are outside the normal limits and considered by the Investigator to be clinically significant.
  • 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.
  • 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.
  • Participants with a clinical history of significant cardiovascular disease in the past 12 months.
  • Participants with a complication or medical history of malignant tumor, other than basal cell or squamous cell carcinomas of the skin.
  • Participants who, in the Investigator's opinion, will be unable to adhere to study visits and procedures.
  • Participants who have received investigational therapy other than CNP-103 within 28 days or 5 half-lives, whichever is longer, prior to Screening.
  • Participants with any known active condition which, in the Investigator's opinion, makes the participant unsuitable for study participation.
  • Known sensitivity to any components of CNP-103.

Recruiting US locations

  • Wake Research - Tucson

    Tucson, AZ 85710

    Site contact: Namrata Oza · 520-210-7930 · noza@wakeresearch.com

  • Liver Institute PLLC

    Tucson, AZ 85716

    Site contact: Nicolette Brown · 520-209-1757 · nbrown@liverinstitutepllc.org

  • Hoag Memorial Hospital

    Newport Beach, CA 92663

    Site contact: Brittany Dennis · 949-764-6896 · brittany.dennis@hoag.org

  • Rady Children's Hospital San Diego

    San Diego, CA 92123

    Site contact: Carla Logan · 858-966-8400 · clogan1@rchsd.org

  • Diablo Clinical Research

    Walnut Creek, CA 94598

    Site contact: Drew Jaffe · 9259307287 · djaffe@diabloclinical.com

  • Barbara Davis Center for Childhood Diabetes

    Aurora, CO 80045

    Site contact: Hali Broncucia · 3037247526 · hali.broncucia@cuanschutz.edu

  • Southwest General Healthcare Center

    Fort Myers, FL 33907

    Site contact: Daniela Pargas · 239-931-3368 · daniela@swghealthcare.com

  • University of Florida

    Gainesville, FL 32610

    Site contact: Magali Jorand-Fletcher · 352-294-5760 · magali20@ufl.edu

  • Evolution Research Center

    Hialeah, FL 33012

    Site contact: Ana Fernandez · 786-708-6008 · afernandez@evolutionresearchcenter.com

  • Nemours Children's Health

    Jacksonville, FL 32207

    Site contact: Jennifer Pann · 904-776-2810 · jennifer.pann@nemours.org

  • University of Miami

    Miami, FL 33136

    Site contact: Danay Saavedra · 305-243-6616 · dxs4415@med.miami.edu

  • DY Professional Research Center

    Miami, FL 33176

    Site contact: Yesenia Escarpio · 3059828331 · yescarpio@dymedicalresearch.com

  • University of South Florida

    Tampa, FL 33612

    Site contact: Elizabeth Dunn · 813-974-4886 · eadunn3@usf.edu

  • Atlanta Diabetes Association

    Atlanta, GA 30318

    Site contact: Amanda Maxson · 404-355-4393 · amaxson@atlantadiabetes.com

  • Emory University

    Atlanta, GA 30322

    Site contact: Meaza Girmay · 404-778-6382 · meaza.girmay@emory.edu

  • Children's Healthcare of Atlanta

    Atlanta, GA 30329

    Site contact: Jordyn Turner · 404-785-3690 · Jordyn.Turner@choa.org

  • Rocky Mountain Diabetes and Osteoporosis Center

    Idaho Falls, ID 83404

    Site contact: Ben Houston · 208-525-3739 · ben.houston@rmclinicalresearch.com

  • Ann & Robert H. Lurie Children's Hospital

    Chicago, IL 60611

    Site contact: Rohin Sagar · 312-227-9403 · rsagar@luriechildrens.org

  • Northwestern University

    Chicago, IL 60611

    Site contact: Stefanie Hermann · 312-926-8693 · s-herrmann@northwestern.edu

  • Southern Illinois University School of Medicine

    Springfield, IL 62702

    Site contact: Rebecca Owens · 217-545-7321 · rowens29@siumed.edu

  • Riley Hospital for Children- Indiana University

    Indianapolis, IN 46202

    Site contact: Nate De Jong · 317-278-4874 · nadejong@iu.edu

  • Barry J. Reiner, MD, LLC

    Baltimore, MD 21229

    Site contact: Lee Bromberger · 410-646-4009 · reinerstudy.lee@gmail.com

  • Joslin Diabetes Center

    Boston, MA 02215

    Site contact: Abigail Coryell · 617-309-1909 · acoryell@joslin.harvard.edu

  • University of Michigan

    Ann Arbor, MI 48109

    Site contact: Adam Neidert · 734-615-0539 · aneidert@med.umich.edu

  • Embassy Research Network

    Bloomfield Township, MI 48302

    Site contact: Zander Minano · 248-622-4083 · zminano@embassyresearch.com

  • University of Minnesota

    Minneapolis, MN 55454

    Site contact: Veronica Jones-Carr · 612-625-9709 · jone2678@umn.edu

  • Children's Mercy Hospital

    Kansas City, MO 64108

    Site contact: Ashley Parks · 816-302-8419 · anparks@cmh.edu

  • Washington University School of Medicine

    St Louis, MO 63110

    Site contact: Elizabeth Sellitto · 314-362-6821 · esellitto@wustl.edu

  • UBMD Pediatrics - University of Buffalo

    Buffalo, NY 14203

    Site contact: Amanda House · 716-323-0075 · ahouse@upa.chob.edu

  • Hassenfield Children's Hospital

    New York, NY 10016

    Site contact: Jeniece Ilkowitz · 212-263-9910 · jeniece.ilkowitz@nyulangone.org

  • NYU Langone Diabetes & Endocrine Associates

    New York, NY 10017

    Site contact: Amanda Baly · 212-637-7000 · Amanda.Baly@nyulangone.org

  • Duke University

    Durham, NC 27710

    Site contact: Kia Gaskins · 919-613-0234 · kiah.gaskin@duke.edu

  • Physicians East, PA

    Greenville, NC 27834

    Site contact: Kirsten Goff · 252-413-6299 · ktaylor@physicianseast.com

  • Wake Research - Raleigh

    Raleigh, NC 27612

    Site contact: LaTosha Gonzalez · 9192142514 · lgonzalez@wakeresearch.com

  • Superior Clinical Research

    Smithfield, NC 27577

    Site contact: Briana White · 9199388058 · briana@superiorclinicalresearch.com

  • University Hospitals Cleveland Medical Center

    Cleveland, OH 44106

    Site contact: Quiana Howard · 216-286-0021 · Quiana.Howard@UHhospitals.org

  • University Diabetes & Endocrine Consultants

    Chattanooga, TN 37411

    Site contact: Gina Harris · 423-265-3561 · gharris@drhuffman.com

  • Le Bonhuer Children's

    Memphis, TN 38105

    Site contact: Christine Watkins · 901-287-5579 · christine.watkins@lebonheur.org

  • Texas Diabetes & Endocrinology

    Austin, TX 78749

    Site contact: Emmanuel Lopez · 5123343505 · elopez@texasdiabetes.com

  • M3 Wake Research - Dallas

    Dallas, TX 75246

    Site contact: Vicki Martinez · 469-297-3074 · vmartinez@wakeresearch.com

  • Accurate Clinical Research, Inc

    Humble, TX 77346

    Site contact: Valerie Blanco · 2817603930 · vblanco@accurateclinicalresearch.com

  • Diabetes & Glandular Disease (DGD) Clinic, P.A.

    San Antonio, TX 78229

    Site contact: Bobbi Hernandez · 2106148612 · bobbi.hernandez@dgdclinic.com

  • TopLine Clinical, Inc

    Waxahachie, TX 75165

    Site contact: Lacey Powers · 972-965-3247 · lacey@toplineclinical.com

  • Benaroya Research Institute

    Seattle, WA 98101

    Site contact: Erica Bourget · 206-341-8997 · EBourget@benaroyaresearch.org

  • University of Washington Diabetes Institute

    Seattle, WA 98109

    Site contact: Dori Khakpour · 206-945-4965 · dorik@uw.edu

Study contacts (from the official record)

  • Stephanie Slaughter · 317-727-2551 · sslaughter@courpharma.com
  • Cristina Varela · 901-517-2602 · cvarela@courpharma.copm
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CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently… (NCT06783309) | Bored Studies