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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
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* Drug: liraglutide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide<br> | Drug: liraglutide<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Injected s.c./subcutaneously (under the skin) once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum postprandial gallbladder ejection fraction (GBEFmax) |  | At 12 weeks (visit 9) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) | 
| 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 first dose (visit 4,day 2) after 12 weeks (visit 9, day 85) | 
| Area under the paracetamol concentration-time curve |  | At 12 weeks (visit 9) | 
| Incremental area under the plasma glucose 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 12 weeks (visit 9) |