A Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects.
Phase 1
Completed
- Conditions
- Metabolism and Nutrition DisorderObesity
- Interventions
- Drug: placebo
- Registration Number
- NCT02717858
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo - Liraglutide liraglutide -
- Primary Outcome Measures
Name Time Method Maximum postprandial gallbladder ejection fraction (GBEFmax) At 12 weeks (visit 9)
- Secondary Outcome Measures
Name Time Method GBEFmax (maximum gallbladder ejection fraction) after first treatment dose At first treatment dose (visit 4, day 2) Gallbladder volume At 12 weeks (visit 9) Area under gallbladder EF-time (ejection fraction) curve At first dose (visit 4, day 2),after 12 weeks (visit 9, day 85) Area under gallbladder EF-time curve At 12 weeks (visit 9) Area under the paracetamol concentration-time curve At 12 weeks (visit 9) Incremental area under the plasma glucose concentration-time curve At 12 weeks (visit 9)
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇰Hellerup, Denmark