A Phase 1B/2A Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of Cnp-103 in Subjects Ages 12-35 With Recent Onset Stage 3 Type 1 Diabetes

Study on Investigational Medication for Recent Onset Type 1 Diabetes

L
Linda DiMeglio, MD

Primary Investigator

Enrolling By Invitation
12 years - 35 years
All
Phase 1/2
1 participants needed
4 Locations

Brief description of study

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. 

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

The approximately 208-day study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (90 days).

The study is planned to enroll up to three cohorts in two descending age groups [(adults, 18-35, and adolescents, 12-17), six subjects per cohort, approximately 18 subjects total per age range, for a total of 36 subjects)] at multiple ascending dose levels in the Escalation Phase. Each adolescent dose level will be staggered after the corresponding cohort of adults (18-35) has completed the Day 15 office visit and DMC review. Subjects will be randomized in a 2:1 ratio to receive either CNP-103 or placebo (0.9% Sodium Chloride Injection USP) as a 200 mL intravenous infusion on Day 1, Day 8, and Day 90.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Type 1 Diabetes, T1D, Riley
  • Age: 12 years - 35 years
  • Gender: All

Inclusion Criteria:

  • 1. Subjects 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 T1D within 180 days prior to study enrollment according to American Diabetes Association [ADA] criteria.

    4. Subjects 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.

    5. For subjects on any medication used to treat the symptoms of T1D (e.g., corticosteroids), subjects must be on a stable dose for a minimum of 1 month prior to enrollment and must agree not to increase their dose from Screening Visit through End of Study Visit unless reviewed and approved by the medical monitor and the site investigator

Exclusion Criteria:

  • Subjects who have used the following medications:

    a. Within 5 half-lives or 90 days prior to first dose, whichever is shorter: i. Oral immunomodulators: (i.e., cyclosporin, azathioprine, methotrexate) ii. B cell depleting immunotherapy (e.g., Rituximab) iii. Other anti-diabetic agents besides insulin (e.g., Verapamil). Insulin is allowed if on a stable dose for 30 days prior to the Day 1 dose). b. Within 6 months prior to first dose: i. T cell modifying immunotherapy (e.g., Abatacept, Etanercept, Ustekinumab) within 6 months prior to the first dose c. Within 12 months prior to first dose: i. T cell depleting immunotherapy (e.g., Teplizumab) within 12 months prior to the first dose d. Exclusion of additional immunomodulation will be at the discretion of the medical monitor and study site Investigator.

    2. Subjects who present with diabetic ketoacidosis (DKA) at the time of diagnosis. Note: any MMTT must be performed no sooner than 2 weeks and up to 4 weeks after DKA diagnosis.

This study investigates the safety, tolerability, and effects of an investigational medication for people aged 12 to 35 with recent onset Stage 3 Type 1 diabetes. Type 1 diabetes is a chronic disease where the body's defense system mistakenly attacks specific cells within the pancreas, which make insulin. Insulin helps control sugar in the blood. When these cells are damaged, they cannot make enough insulin. This means people with Type 1 diabetes need to take insulin every day to keep their blood sugar at safe levels.

Participants will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. The treatment is given as an intravenous infusion on specific days during the study. The study will also include various evaluations to monitor the participants' health and the effects of the treatment.

  • Who can participate: People aged 12 to 35 years with a recent diagnosis of Type 1 diabetes, who can provide informed consent, may participate. Participants must have a specific C-peptide level and be on a stable dose of diabetes medication.
  • Study details: Participants will receive either the investigational medication or a placebo through an intravenous infusion. The study involves monitoring health effects.
  • Study timelines: The study will last 208 days.
Updated on 16 Jul 2026. Study ID: PENDO-COUR-CNP-103-CL-201, 28451
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only