CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)
This study tests a new drug called CNP-103 in teenagers and young adults (ages 12-35) who were recently diagnosed with Type 1 Diabetes within the last 6 months. The research will evaluate how safe the drug is, how well it works, and how the body responds to it over about 13 months of participation.
Key Objective: The trial is testing whether CNP-103 can help preserve remaining insulin-producing cells and potentially slow or halt the progression of Type 1 Diabetes in newly diagnosed patients.
Who to Consider: Young people aged 12-35 who have been diagnosed with Type 1 Diabetes within the past 6 months and are interested in potentially slowing disease progression should consider enrolling.
Trial Parameters
Brief Summary
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).
Eligibility Criteria
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