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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT07241533
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 years or older, male or female.
* Overweight or obesity, defined as a body mass index (BMI) of 24.0-45.0 kg/m².
* Able and willing to provide written informed consent.
Exclusion Criteria:
* Active pulmonary tuberculosis, malignant tumors, human immunodeficiency virus (HIV) infection, or other severe infectious or immunocompromising conditions.
* Severe liver injury (AST or ALT \> 3 times the upper limit of normal) or severe renal dysfunction/end-stage renal disease (eGFR \< 30 mL/min/1.73 m²).
* Severe cardiovascular diseases, including angina pectoris, myocardial infarction, or stroke within the past 6 months.
* Severe gastrointestinal disorders, or a history of gastrointestinal surgery within the past year.
* Secondary causes of obesity, including Cushing's syndrome, primary hypothyroidism, hypothalamic obesity, acromegaly; or drug-induced obesity (e.g., antipsychotics, glucocorticoids).
* Currently receiving other anti-obesity treatments, a previous history of bariatric surgery, or a \>5% reduction in body weight within the past 3 months.
* Current smoker or habitual smoker within the past 3 months.
* type 1 or type 2 diabetes mellitus or currently taking hypoglycemic medications.
* Pregnancy or planning pregnancy, or breastfeeding.
* Unable to complete a 3-month follow-up due to health conditions or relocation.
* Participation in any clinical study within the past 4 weeks.
* Other conditions considered by investigators as unsuitable for participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07241533
Study Brief:
Protocol Section:
NCT07241533