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New drug aims to control type 1 diabetes early

NCT ID NCT06783309

Disease control Sponsor: COUR Pharmaceutical Development Company, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 7 times

Summary

This study tests a new drug, CNP-103, in people aged 12 to 35 who were diagnosed with stage 3 type 1 diabetes within the last 6 months. The goal is to see if the drug is safe and can help control the disease. Participants will receive either the drug or a placebo, and researchers will monitor side effects and how well the drug works over about 13 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 35 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

T1D T1DM T1DM - type 1 diabetes mellitus Type 1 diabetes Type 1 diabetes (juvenile onset) Type 1 diabetes in adolescence Type 1 diabetes in children Type 1 diabetes mellitis Type 1 diabetes mellitus Type 1 diabetes patients

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    45 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accurate Clinical Research, Inc

    RECRUITING

    Humble, Texas, 77346, United States

  • Ann & Robert H. Lurie Children's Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Atlanta Diabetes Association

    RECRUITING

    Atlanta, Georgia, 30318, United States

  • Barbara Davis Center for Childhood Diabetes

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Barry J. Reiner, MD, LLC

    RECRUITING

    Baltimore, Maryland, 21229, United States

  • Benaroya Research Institute

    RECRUITING

    Seattle, Washington, 98101, United States

  • Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Mercy Hospital

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • DY Professional Research Center

    RECRUITING

    Miami, Florida, 33176, United States

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

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Diablo Clinical Research

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Embassy Research Network

    RECRUITING

    Bloomfield Township, Michigan, 48302, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Evolution Research Center

    RECRUITING

    Hialeah, Florida, 33012, United States

  • Hassenfield Children's Hospital

    RECRUITING

    New York, New York, 10016, United States

  • Hoag Memorial Hospital

    RECRUITING

    Newport Beach, California, 92663, United States

  • Joslin Diabetes Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Le Bonhuer Children's

    RECRUITING

    Memphis, Tennessee, 38105, United States

  • Liver Institute PLLC

    RECRUITING

    Tucson, Arizona, 85716, United States

  • M3 Wake Research - Dallas

    RECRUITING

    Dallas, Texas, 75246, United States

  • NYU Langone Diabetes & Endocrine Associates

    RECRUITING

    New York, New York, 10017, United States

  • Nemours Children's Health

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Physicians East, PA

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Rady Children's Hospital San Diego

    RECRUITING

    San Diego, California, 92123, United States

  • Riley Hospital for Children- Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Rocky Mountain Diabetes and Osteoporosis Center

    RECRUITING

    Idaho Falls, Idaho, 83404, United States

  • Southern Illinois University School of Medicine

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Southwest General Healthcare Center

    RECRUITING

    Fort Myers, Florida, 33907, United States

  • Superior Clinical Research

    RECRUITING

    Smithfield, North Carolina, 27577, United States

  • Texas Diabetes & Endocrinology

    RECRUITING

    Austin, Texas, 78749, United States

  • TopLine Clinical, Inc

    RECRUITING

    Waxahachie, Texas, 75165, United States

  • UBMD Pediatrics - University of Buffalo

    RECRUITING

    Buffalo, New York, 14203, United States

  • University Diabetes & Endocrine Consultants

    RECRUITING

    Chattanooga, Tennessee, 37411, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55454, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33612, United States

  • University of Washington Diabetes Institute

    RECRUITING

    Seattle, Washington, 98109, United States

  • Wake Research - Raleigh

    RECRUITING

    Raleigh, North Carolina, 27612, United States

  • Wake Research - Tucson

    RECRUITING

    Tucson, Arizona, 85710, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.