Clinical trial NCT02717858: A Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects.
Official title: A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Effects of Liraglutide on Gallbladder Emptying in Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-03-24
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum postprandial gallbladder ejection fraction (GBEFmax)
timeFrame: At 12 weeks (visit 9)
Secondary outcomes:
measure: GBEFmax (maximum gallbladder ejection fraction) after first treatment dose
timeFrame: At first treatment dose (visit 4, day 2)
measure: Gallbladder volume
timeFrame: At first dose (visit 4, day2),after 12 weeks (visit 9, day 85)
measure: Gallbladder volume
timeFrame: At 12 weeks (visit 9)
measure: Area under gallbladder EF-time (ejection fraction) curve
timeFrame: At first dose (visit 4, day 2),after 12 weeks (visit 9, day 85)
measure: Area under gallbladder EF-time curve
timeFrame: At 12 weeks (visit 9)
measure: Area under the paracetamol concentration-time curve
timeFrame: At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)
measure: Area under the paracetamol concentration-time curve
timeFrame: At 12 weeks (visit 9)
measure: Incremental area under the plasma glucose concentration-time curve
timeFrame: At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)
measure: Incremental area under the plasma glucose concentration-time curve
timeFrame: At 12 weeks (visit 9)
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Nexoe-Larsen CC, Sorensen PH, Hausner H, Agersnap M, Baekdal M, Bronden A, Gustafsson LN, Sonne DP, Vedtofte L, Vilsboll T, Knop FK. Effects of liraglutide on gallbladder emptying: A randomized, placebo-controlled trial in adults with overweight or obesity. Diabetes Obes Metab. 2018 Nov;20(11):2557-2564. doi: 10.1111/dom.13420. Epub 2018 Jul 10.