Phase 2 Type 1 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing and able to sign an approved consent form agreeing to take part in the study
• Men and women (who are not pregnant or breastfeeding) between the ages of 12 and 35 years old
• People who have been diagnosed with Stage 3 Type 1 Diabetes within the last 180 days, based on American Diabetes Association standards
• People who are already following standard diabetes care, including insulin therapy, a nutrition plan, and regular exercise or other relevant care
• People whose pancreas is still producing a small but measurable amount of insulin (shown by a specific test result called a "peak stimulated C-peptide" above a certain level)
• People who had a serious diabetes-related complication called diabetic ketoacidosis (DKA) may still be eligible, provided a specific test is done at least 2 weeks after the episode resolved
• People who are on corticosteroid medications or other diabetes-related medications (apart from insulin) and are willing to stop taking them for at least two weeks before joining, and to avoid them during the trial if possible
• Women who cannot become pregnant due to surgery or having gone through menopause
• Women who could potentially become pregnant but agree not to become pregnant during the study, have a negative pregnancy test at the start, and agree to use one highly effective form of contraception from screening through to Day 365
• Women who agree not to breastfeed from the start of screening through to Day 365
• Women who agree not to donate eggs from the start of screening through to Day 365
• Men with a partner who could become pregnant, where both the participant and their partner agree to use an effective form of contraception from screening through to Day 365
• People who weigh more than 35 kg at screening (for the lower dose groups) or more than 50 kg at screening (for the higher dose group)
• People whose body weight is within a healthy range for their age — for those aged 12–17, this is based on standard growth charts; for those aged 18–35, a body mass index (BMI) between 18.0 and 30.0 (not including those exact numbers)

Who may not be able to join:

• People who are unable to follow the study rules around medications that are not allowed during the trial
• People whose use of immune-affecting medications is considered unsuitable by the medical team overseeing the trial (confirm with trial site)
• People with a history of tuberculosis or a positive tuberculosis blood test
• People who have received certain vaccines recently — specifically: a live vaccine within the last 28 days, a subunit vaccine within the last 14 days, a COVID-19 vaccine within the last 14 days, or any other planned vaccine in the period starting 14 days before screening through to Day 90 plus one week (note: the annual flu vaccine is not a reason for exclusion)
• People who have had a known or suspected active infection, including COVID-19, at the time of screening or within the 2 weeks before screening — a minimum of 2 weeks of recovery after COVID-19 is required
• People whose blood test results at screening are outside normal ranges and considered medically significant by the study doctor
• People who test positive for hepatitis B, hepatitis C, or HIV at screening
• People with a history of, or currently active, immune system or autoimmune conditions other than Type 1 Diabetes — unless the medical team reviews the condition and considers participation acceptable
• People who have had a significant heart or cardiovascular condition in the past 12 months
• People with a history of cancer, other than certain minor skin cancers (basal cell or squamous cell carcinoma)
• People who, in the study doctor's opinion, would be unable to attend study visits or follow study procedures
• People who have taken part in another clinical trial involving an investigational treatment (other than CNP-103) within the last 28 days or within 5 half-lives of that treatment, whichever is longer
• People with any other active medical condition that the study doctor believes makes participation unsuitable
• People with a known allergy or sensitivity to any ingredients in the study drug, CNP-103

Important: Always verify eligibility with the trial site directly before applying.