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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT01832532
Eligibility Criteria:
Inclusion Criteria:
* Age 18-60 years
* Diagnosis of severe obstructive sleep apnea (OSA) AHI ≥ 8 /hour of sleep
* Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, compliance to visit schedule
* BMI of ≥ 27
* For Cohort 1: If female of childbearing capacity, willing to use acceptable birth control during use of study drug
Exclusion Criteria:
* A major medical condition such as renal or hepatic failure
* Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 inhibitors or insulin within the last 3 months prior to screening
* Diagnosis of type 1 or type 2 diabetes per judgment of the investigator
* BMI \< 27
* History of glycosylated hemoglobin (HbA1c) equal to or above 6.5%
* Significant craniofacial abnormalities that may cause OSA
* Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator
* Use of central stimulants, hypnotics, mirtazepine, opioids, trazodone or drugs in the incretin family within the previous 3 months prior to screening
* Previous surgical treatment for obesity
* Familial or personal history of Multiple Endocrine Neoplasia type 2 or familial Medullary Thyroid Carcinoma
* Personal or immediate family history of thyroid cancer
* History of chronic pancreatitis or idiopathic acute pancreatitis
* History of Major Depressive Disorder or suicide attempts
* Systolic blood pressure equal to or above 160 mmHg and/or diastolic blood pressure equal to or above 100 mmHg
* History of alcoholism
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01832532
Study Brief:
Protocol Section:
NCT01832532