Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT07222332
Eligibility Criteria:
Inclusion Criteria:
* Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention
* Have at least one diabetes-related autoantibody found at screening
* Show signs of remaining beta-cell function
* stimulated (peak or 90 min) C-peptide ≥0.2 nmol/L (0.6 ng/mL) at screening, or
* random C-peptide result \>0.3 nmol/L (0.9 ng/mL) during the screening period
* Weigh at least 8 kilograms (kg) (18 pounds) at screening
Exclusion Criteria:
* Have any other type of diabetes including gestational
* Have uncontrolled high blood pressure
* Have had a heart attack, heart disease, stroke, or heart failure
* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy
* Have a current or recent clinically serious medical condition or infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
35 Years
Study:
NCT07222332
Study Brief:
Protocol Section:
NCT07222332