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 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 12:09 AM
NCT ID:
NCT03100058
Eligibility Criteria:
Inclusion Criteria:
1. informed consent
2. (BMI\>=30) or (BMI\>=27 with history of CV disease, hypertension, dyslipidemia, pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome)
3. willing to comply with life-style intervention and treatment during the full duration of the study (approximately 54 weeks)
Exclusion Criteria:
* Hypersensitivity to any of the study medications
* Pregnancy or lactating women
* History of malignancies
* Use of pharmacologically active weight loss products
* Bariatric surgery
* Ketoacidosis, lactic acidosis, hyperosmolar coma in the 6 months before the screening visit.
* HbA1c \>10% at the screening visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03100058
Study Brief:
Protocol Section:
NCT03100058