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:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT06271200
Eligibility Criteria:
Inclusion Criteria:
* Men or women aged from ≥ 20 years to 65 years
* BMI 27.0 to 45.0 kg/m2 with metabolic syndrome by IDF definition
Exclusion Criteria:
* History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis
* Diagnosis of type 1 or type 2 diabetes and regular taking oral or injection hypoglycemic therapy
* History of malignant tumors with active managements.
* History of medullary thyroid carcinoma or diagnosis of multiple endocrine neoplasia syndrome type 2 (MEN 2)
* Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2)
* History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months History of severe gastrointestinal diseases or gastrointestinal surgery in the past 6 months
* History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity without regular managements.
* History of hypersensitivity to semaglutide or any component of RYBELSUS®, or history of severe hypersensitivity reactions to Forxiga, such as anaphylaxis or angioedema.
* Taking medications affecting weight or energy intake/energy expenditure in the last 3 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician
* Currently participating in weight loss programs or weight change in the past 3 months (\>5% current body weight)
* Women who are pregnant or plan to become pregnant
* Patients who cannot be followed for 3 years (due to a health situation or migration)
* Patients who are unwilling or unable to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT06271200
Study Brief:
Protocol Section:
NCT06271200