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:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT05340868
Eligibility Criteria:
Inclusion Criteria:
* Informed consent was given before any study-related action on the subject.
* Age: 18-65 years old
* Body mass index (BMI) \>30 kg/m2 or \>27 kg/m2 when accompanied by prediabetes, diagnosed according to the criteria of the American Diabetes Association
Exclusion Criteria:
* Patients diagnosed with a serious chronic disease, including:
* Ischemic heart disease
* Heart failure (NYHA class III-IV)
* Severe renal insufficiency (eGFR \<30 ml/min)
* Severe liver diseases
* Inflammatory bowel disease
* Diabetic gastroparesis
* Cancer - currently or in the last five years prior to screening
* Chronic obstructive pulmonary disease
* History of mental illness, major depression or other severe mental disorders
* Use of any medications with clinically-proven significant weight gain or loss effects
* History of undergoing bariatric surgery or other surgery involving the stomach that could affect the absorption of the study drug (according to the investigator's opinion)
* History of idiopathic acute pancreatitis
* A family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid cancer
* For women - pregnancy, breastfeeding or planning pregnancy.
* Women of childbearing age who are not using highly effective methods of contraception
* Known or suspected hypersensitivity to the test product
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05340868
Study Brief:
Protocol Section:
NCT05340868