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 @ 12:14 PM
Ignite Modification Date:
2025-12-24 @ 12:14 PM
NCT ID:
NCT02235961
Eligibility Criteria:
Inclusion Criteria:
* Male, age between (both inclusive) 18 and 55 years at the time of signing inform consent
* Overweight or obese but otherwise healthy male subjects; BMI of between or equal to 27.0 and 35.0 kg/m\^2
Exclusion Criteria:
* Thyroid stimulating hormone values outside 0.4-6.0 mIU/l
* HbA1c (glycated hemoglobin) above or equal to 6.5%
* Any clinically relevant ECG (electrocardiogram) findings (e.g. 2nd or 3rd degree AV-block), in particular subjects with repeated demonstration of a QTcF (QT interval corrected by Fridericia formula) interval above 430 ms
* A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
* The use of concomitant medications that prolong the QT/QTc interval
* Obesity caused by endocrinology disorders (e.g. Cushing's Syndrome)
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
* Calcitonin above 50 ng/L
* History of pancreatitis (acute or chronic)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02235961
Study Brief:
Protocol Section:
NCT02235961