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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT05659368
Eligibility Criteria:
Inclusion Criteria:
1. A definitive diagnosis of Wolfram syndrome, as determined by the following:
1. Documented diabetes mellitus diagnosed under 16 completed years according to WHO or ADA criteria AND
2. Documented functionally relevant recessive mutations on both alleles of the WFS1 gene or dominant mutation on one allele of the WFS1 gene based on historical test results (if available) or from a qualified laboratory at screening;
2. Aged 5 years or older;
3. The patient, patient's parent(s), or legally authorized guardian(s) must have voluntarily signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient. The guardians' consent and patient's assent, as relevant, must be obtained;
4. Females of child bearing potential will only be included after a negative highly sensitive urine pregnancy test. If sexually active, they must agree to use a highly effective contraception measure;
5. Patient willing to wear a continuous glucose monitor.
Exclusion Criteria:
1. Clinically significant non-Wolfram related CNS involvement which is judged by the Investigator to be likely to interfere with the accurate administration and interpretation of protocol assessments;
2. A history of pancreatitis;
3. Pre-existing thyroid disease;
4. A personal or family history of medullary thyroid carcinoma;
5. Multiple Endocrine Neoplasia syndrome type 2;
6. Active liver or renal disease, personal or family history of liver/kidney dysfunction related to known genetic disorders;
7. Treatment with any investigational drug within the 30 days prior to Trial entry;
8. Current therapy with of GLP-1 agonist or DDP-4 inhibitor or a known hypersensitivity to GLP-1 agonist;
9. Any other acute or chronic medical, psychiatric, social situation or laboratory result that, based on investigator's judgment, would jeopardize patient safety during trial participation, cause inability to comply with the protocol, or affect the Trial outcome;
10. Breastfeeding;
11. Pre-existing ocular disease (corneal or lens diseases and any other retinal or optic nerve non-Wolfram related diseases).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT05659368
Study Brief:
Protocol Section:
NCT05659368