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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT02835235
Eligibility Criteria:
Inclusion Criteria:
* Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
* Body mass index between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening.
Exclusion Criteria:
* Haemoglobin A1c (HbA1c) equal or above 6.5%
* Any clinically significant weight change (above or equal to 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program) within the last 90 days prior to screening
* Any prior obesity surgery or currently present gastrointestinal implant.
* Abnormal ECG (electrocardiogram) results including 2nd or 3rd degree AV-block, prolongation of the QRS complex above 120 ms, or the QTcF interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator
* A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
* History of pancreatitis (acute or chronic)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02835235
Study Brief:
Protocol Section:
NCT02835235