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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT03591718
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients ≥ 18 years and \< 70 years of age at screening
* Body Mass Index (BMI) ≥ 27 kg/m2 and \<40 kg/m2 at screening
* A minimum absolute body weight of 70 kg at screening and a stable body weight (defined as no more than 5% change) 3 months prior to screening
* HbA1c \<6.5%
* Further inclusion criteria apply
Exclusion Criteria:
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Supine blood pressure (BP) ≥160/100 mmHg at screening
* Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Further exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03591718
Study Brief:
Protocol Section:
NCT03591718