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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT06825793
Eligibility Criteria:
Inclusion Criteria:
* Age 18-60 years
* BMI ≥ 30 kg/m²
* At least one self-reported unsuccessful attempt at lifestyle weight loss
Exclusion Criteria:
* Weight change (self-reported) \> 5% in the past 3 months prior to screening
* Use of any medication for obesity indication in the past 3 months prior to screening.
* Use of antidiabetic medications in the past 3 months, or HbA1c ≥ 6.5%, or a history of Type 1 or Type 2 diabetes.
* Use of immunosuppressants, corticosteroids, antidiarrheal drugs, antibiotics, probiotics, lipid-lowering medications, and/or other gastrointestinal motility drugs in the past 3 months prior to screening.
* A history of endocrine-related overweight or obesity diagnoses, such as Cushing's syndrome.
* Triglycerides ≥ 500 mg/dL (5.65 mmol/L) at screening.
* Known clinically significant gastric emptying abnormalities (e.g., severe diabetic gastroparesis or gastric outlet obstruction), gastrointestinal diseases, or surgical history.
* Thyroid dysfunction.
* History of mental illness.
* History or family history of multiple endocrine neoplasia or medullary thyroid cancer, or calcitonin ≥ 6 pg/mL.
* Abnormal liver function at screening, defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 3\*ULN.
* Abnormal kidney function at screening, defined as estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.75m².
* History of cardiovascular disease.
* History of malignancy.
* Pregnancy or breastfeeding.
* Any other physiological, psychological, or other conditions deemed by the investigator as unsuitable for participation in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06825793
Study Brief:
Protocol Section:
NCT06825793