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 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT04447261
Eligibility Criteria:
Inclusion criteria
* Male and female patients, age ≥ 18 and \< 70
* Body Mass Index ≥ 27 kg/m2 and \< 40 kg/m2 at screening
* Stable body weight (defined as no more than 5% change) within 3 months prior to screening
* further inclusion criteria apply
Exclusion criteria
* Females of childbearing potential
* Clinically relevant concomitant disease per investigator judgment
* Any condition or disease requiring permanent pharmacotherapy during the trial
* Any history of lifetime suicidal behaviour and any suicidal ideation of type 2 - 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 12 months
* further exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04447261
Study Brief:
Protocol Section:
NCT04447261