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

Primary Purpose

Metabolism and Nutrition Disorder, Obesity

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
liraglutide
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolism and Nutrition Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Liraglutide

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Maximum postprandial gallbladder ejection fraction (GBEFmax)

Secondary Outcome Measures

GBEFmax (maximum gallbladder ejection fraction) after first treatment dose
Gallbladder volume
Gallbladder volume
Area under gallbladder EF-time (ejection fraction) curve
Area under gallbladder EF-time curve
Area under the paracetamol concentration-time curve
Area under the paracetamol concentration-time curve
Incremental area under the plasma glucose concentration-time curve
Incremental area under the plasma glucose concentration-time curve

Full Information

First Posted
March 15, 2016
Last Updated
June 26, 2018
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02717858
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 16, 2016 (Actual)
Primary Completion Date
February 27, 2017 (Actual)
Study Completion Date
February 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism and Nutrition Disorder, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Injected s.c./subcutaneously (under the skin) once daily.
Primary Outcome Measure Information:
Title
Maximum postprandial gallbladder ejection fraction (GBEFmax)
Time Frame
At 12 weeks (visit 9)
Secondary Outcome Measure Information:
Title
GBEFmax (maximum gallbladder ejection fraction) after first treatment dose
Time Frame
At first treatment dose (visit 4, day 2)
Title
Gallbladder volume
Time Frame
At first dose (visit 4, day2),after 12 weeks (visit 9, day 85)
Title
Gallbladder volume
Time Frame
At 12 weeks (visit 9)
Title
Area under gallbladder EF-time (ejection fraction) curve
Time Frame
At first dose (visit 4, day 2),after 12 weeks (visit 9, day 85)
Title
Area under gallbladder EF-time curve
Time Frame
At 12 weeks (visit 9)
Title
Area under the paracetamol concentration-time curve
Time Frame
At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)
Title
Area under the paracetamol concentration-time curve
Time Frame
At 12 weeks (visit 9)
Title
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)
Title
Incremental area under the plasma glucose concentration-time curve
Time Frame
At 12 weeks (visit 9)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
29892986
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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