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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT02717858
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) equal to or above 27.0 kg/m\^2
* Stable body weight (less than 3 kg self-reported change during the previous 3 months)
* Ultrasound assessment of gallbladder volume of an acceptable quality at screening, as judged by the investigator
Exclusion Criteria:
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or longacting injections))
* History of gastrointestinal surgery or other medical procedure precluding gallbladder emptying assessment (appendectomy is allowed) or any significant digestive disease per the judgement of the investigator
* History of pancreatitis (acute or chronic) or any gallbladder disease (incl. gallstones, gallbladder sludge, or polyps)
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02717858
Study Brief:
Protocol Section:
NCT02717858