Metabolism and Nutrition Disorder, Obesity
Conditions
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.
Interventions
DRUGliraglutide
Injected s.c./subcutaneously (under the skin) Dose escalation period starting with liraglutide 0.6 mg per day and escalated with weekly increments of 0.6 mg until the target dose 3.0 mg is reached.
DRUGplacebo
Injected s.c./subcutaneously (under the skin) once daily.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum postprandial gallbladder ejection fraction (GBEFmax) | At 12 weeks (visit 9) |
Secondary
| Measure | Time frame |
|---|---|
| GBEFmax (maximum gallbladder ejection fraction) after first treatment dose | At first treatment dose (visit 4, day 2) |
| Gallbladder volume | At first dose (visit 4, day2),after 12 weeks (visit 9, day 85) |
| 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 first dose (visit 4,day 2) after 12 weeks (visit 9, day 85) |
| Incremental area under the plasma glucose concentration-time curve | At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85) |
Countries
Denmark
Outcome results
None listed