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New treatment option for Type 1 Diabetes Mellitus
Official title CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)
ClinicalTrials.gov ID: NCT06783309
What this study is testing
What is CNP-103?
CNP-103 is an investigational medicine, being studied as a potential treatment for type 1 diabetes mellitus.
Also referred to as Treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 35
You may be able to join if
- Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per...
- 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...
- Participants with a peak stimulated C-peptide of \>0.2 nmol/L measured from a screening mixed meal tolerance test (MMTT).
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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)
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- San Diego, California, United States
- Walnut Creek, California, United States
- Aurora, Colorado, United States
- Gainesville, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Springfield, Illinois, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Bloomfield Township, Michigan, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Buffalo, New York, United States
- Syosset, New York, United States
- Durham, North Carolina, United States
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; San Diego, California, United States; Walnut Creek, California, United States; Aurora, Colorado, United States; Gainesville, Florida, United States; Hialeah, Florida, United States and 24 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.