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

June 26, 2018 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
Injected s.c./subcutaneously (under the skin) once daily.
Experimental: Liraglutide
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
GBEFmax (maximum gallbladder ejection fraction) after first treatment dose
Time Frame: At first treatment dose (visit 4, day 2)
At first treatment dose (visit 4, day 2)
Gallbladder volume
Time Frame: At first dose (visit 4, day2),after 12 weeks (visit 9, day 85)
At first dose (visit 4, day2),after 12 weeks (visit 9, day 85)
Gallbladder volume
Time Frame: At 12 weeks (visit 9)
At 12 weeks (visit 9)
Area under gallbladder EF-time (ejection fraction) curve
Time Frame: At first dose (visit 4, day 2),after 12 weeks (visit 9, day 85)
At first dose (visit 4, day 2),after 12 weeks (visit 9, day 85)
Area under gallbladder EF-time curve
Time Frame: At 12 weeks (visit 9)
At 12 weeks (visit 9)
Area under the paracetamol concentration-time curve
Time Frame: At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)
At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)
Area under the paracetamol concentration-time curve
Time Frame: At 12 weeks (visit 9)
At 12 weeks (visit 9)
Incremental area under the plasma glucose concentration-time curve
Time Frame: At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)
At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)
Incremental area under the plasma glucose concentration-time curve
Time Frame: At 12 weeks (visit 9)
At 12 weeks (visit 9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2016

Primary Completion (Actual)

February 27, 2017

Study Completion (Actual)

February 27, 2017

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8022-4192
  • 2014-004772-38 (EudraCT Number)
  • U1111-1163-4641 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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