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:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT05196958
Eligibility Criteria:
* Patients between 18 and 75 years of age
* Patients with inflammatory bowel disease (Crohn's disease (CD) or ulcerative colitis (UC))
* Patient with poorly controlled type 2 diabetes (defined as deviation from the set glycemic target of more than 1% HbA1c)
* Patient with a BMI ≥ 25 kg/m2
* For women of childbearing age: effective contraception\* during treatment and up to 5 weeks after discontinuation
\* Any contraceptive method used regularly and appropriately that has a low failure rate (i.e., less than 1% per year)
* Patient enrolled in a health insurance plan
* Francophone patient
* Patient with free, informed, written consent
Exclusion Criteria:
* Patient with a personal or family history of medullary thyroid cancer
* Patient with an active cancer
* Patient with a history of acute or chronic pancreatitis
* Patients with a history of hypersensitivity to GLP1 analogues (or to any other component of the product)
* Patient with a history of severe GI intolerance to GLP-1 receptor agonists
* Patient already included in a risky interventional research protocol (RIPH1)
* Pregnant or breastfeeding women
* Patients with congestive heart failure New York Heart Association (NYHA) class IV
* Patient with end-stage renal disease
* Patients with clinically significant sustained elevation of resting heart rate
* Patient with anti-GAD antibodies in a previous workup at inclusion
* Patient under guardianship or curatorship
* Patient under court protection
* Patient deprived of liberty
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05196958
Study Brief:
Protocol Section:
NCT05196958