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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717858
• Other study ID #: NN8022-4192
• Secondary ID: 2014-004772-38U1
• Status: Completed
• Phase: Phase 1
• Start date: March 16, 2016
• Est. completion date: February 27, 2017

Study information

• Verified date: June 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 27, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity
• Overweight

Intervention

Drug:
• liraglutide
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.
• placebo
Injected s.c./subcutaneously (under the skin) once daily.

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Nexøe-Larsen CC, Sørensen PH, Hausner H, Agersnap M, Baekdal M, Brønden A, Gustafsson LN, Sonne DP, Vedtofte L, Vilsbøll T, Knop FK. Effects of liraglutide on gallbladder emptying: a randomised, placebo-controlled trial in adults with overweight or obesit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum postprandial gallbladder ejection fraction (GBEFmax)		At 12 weeks (visit 9)
Secondary	GBEFmax (maximum gallbladder ejection fraction) after first treatment dose		At first treatment dose (visit 4, day 2)
Secondary	Gallbladder volume		At first dose (visit 4, day2),after 12 weeks (visit 9, day 85)
Secondary	Gallbladder volume		At 12 weeks (visit 9)
Secondary	Area under gallbladder EF-time (ejection fraction) curve		At first dose (visit 4, day 2),after 12 weeks (visit 9, day 85)
Secondary	Area under gallbladder EF-time curve		At 12 weeks (visit 9)
Secondary	Area under the paracetamol concentration-time curve		At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)
Secondary	Area under the paracetamol concentration-time curve		At 12 weeks (visit 9)
Secondary	Incremental area under the plasma glucose concentration-time curve		At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)
Secondary	Incremental area under the plasma glucose concentration-time curve		At 12 weeks (visit 9)

External Links

•   Clinical Trials at Novo Nordisk