A Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects.

• Status: Completed
• Trial end date: 2017-02-27
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe. The aim of this trial is to investigate the effects of liraglutide on gallbladder emptying in overweight and obese subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide

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