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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07323134
Eligibility Criteria:
Inclusion Criteria:
* 18 to 60 years old;
* BMI ≥ 30kg/m²;
* At least one self-reported history of unsuccessful lifestyle weight loss;
* Subjects who agree to participate in the project and sign the informed consent form.
Exclusion Criteria:
* Weight changes within 3 months prior to screening (self-reported) \>5%;
* Having received any drug treatment for obesity within the three months prior to screening;
* The application of hypoglycemic drugs within 3 months before screening, or HbA1c≥ 6.5%, or a history of type 1 or type 2 diabetes;
* Participants who have received treatment with immunosuppressants, steroids, antidiarrheal drugs, antibiotics, probiotics, lipid-lowering drugs and/or other gastrointestinal motility drugs within 3 months prior to screening;
* Previously diagnosed overweight or obesity due to endocrine causes, such as Cushing's syndrome, etc;
* Triglycerides ≥500mg/dL (5.65mmol/L) during screening;
* It is known that there are clinically significant gastric emptying abnormalities (e.g., severe diabetic gastroparesis or gastric outlet obstruction), a history of gastrointestinal diseases and surgical history;
* Abnormal thyroid function;
* History of mental illness;
* History of multiple endocrine tumors or medullary thyroid cancer, family history, or calcitonin ≥6pg/mL;
* Abnormal liver function during screening, that is, alanine aminotransferase and/or aspartate aminotransferase \> 3\*ULN;
* Abnormal renal function during screening, that is, the estimated glomerular filtration rate is less than 60mL/min/1.75m2;
* History of cardiovascular diseases;
* History of malignant tumors;
* Pregnancy or lactation;
* As determined by the researcher, there are other physical, psychological or other conditions that make one unsuitable to participate in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07323134
Study Brief:
Protocol Section:
NCT07323134