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)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 35 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CNP-103 in people ages 12–35 who were diagnosed with stage 3 type 1 diabetes within the past 6 months. It is the first study of this drug in humans and tests several increasing doses to learn about its safety, side effects, and how well it works. The study lasts about 393 days.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be ages 12–35, with a documented diagnosis of stage 3 type 1 diabetes within 180 days before joining.
  • Be willing and able to give written consent and agree to the study's privacy rules.
  • Receive usual diabetes care, including regular insulin treatment, a food plan, and exercise or other care as needed.
  • Have a C-peptide level above 0.2 nmol/L on a meal test, showing that your body still makes insulin. After diabetic ketoacidosis, a serious acid buildup in the blood, wait at least 2 weeks after recovery before this test.
  • Stop whole-body steroid medicines and diabetes medicines other than insulin at least 2 weeks before joining. Use non-steroid options if needed. Other medicine doses must be stable for at least 1 month, with later increases approved by study doctors.
  • Not be pregnant or breastfeeding. Women who can become pregnant must have a negative pregnancy test and use highly effective birth control through Day 365. Men with partners who can become pregnant must follow birth control rules. Women must not breastfeed or donate eggs through Day 365.
  • Weigh more than 35 kg for the 100 mg or 300 mg dose groups, or more than 50 kg for the 600 mg group.
  • Meet body mass index (BMI), a measure of weight compared with height, limits: ages 12–17 must be within the 5th–95th percentile for age; adults must have a BMI above 18 and below 30.

Who can't join

  • Cannot follow medicine limits, study visits, or procedures; or have another active condition that the study doctor thinks makes joining unsuitable. Other treatments that change the immune system need study doctor review.
  • Have a history of tuberculosis, a positive tuberculosis blood test, or a positive screening test for hepatitis B, hepatitis C, or HIV.
  • Have a known or suspected recent infection, including COVID-19, at screening or in the 2 weeks before it. After COVID-19, at least 2 weeks of recovery is required.
  • Received a live vaccine within 28 days before screening, or a subunit vaccine (made from pieces of a germ) or COVID-19 vaccine series within 14 days. Other planned vaccines from 14 days before screening through Day 97 are restricted; the yearly flu vaccine is allowed.
  • Have important abnormal screening test results, or an immune system disorder other than type 1 diabetes, unless study doctors approve that disorder.
  • Have had serious heart or blood vessel disease in the past 12 months, or have a cancer history other than basal cell or squamous cell skin cancer.
  • Received another study treatment within 28 days before screening, or longer if that treatment takes more time to leave the body.
  • Have a known sensitivity to any part of CNP-103.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (45)

AZ

CA

CO

FL

GA

ID

IL

IN

MA

MD

MI

MN

MO

NC

NY

OH

TN

TX

WA