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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT02717858 (opens ClinicalTrials.gov in a new tab)Other idNN8022-4192Other id2014-004772-38Other idU1111-1163-4641Other id2014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
52 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

Denmark

Start
16 Mar 2016
Primary completion
27 Feb 2017
Completion
27 Feb 2017
First posted
24 Mar 2016 (estimated)
Last update posted
28 Jun 2018
Conditions
Metabolism and Nutrition Disorder · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 1

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

    NCT02717858

    16 Mar 2016 to 27 Feb 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug
  • placeboDrug

Arms2

  • Experimental

    Liraglutide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Maximum postprandial gallbladder ejection fraction (GBEFmax)

    Time frame · At 12 weeks (visit 9)

Secondary outcomes(9)

  1. GBEFmax (maximum gallbladder ejection fraction) after first treatment dose

    Time frame · At first treatment dose (visit 4, day 2)

  2. Gallbladder volume

    Time frame · At first dose (visit 4, day2),after 12 weeks (visit 9, day 85)

  3. Gallbladder volume

    Time frame · At 12 weeks (visit 9)

  4. Area under gallbladder EF-time (ejection fraction) curve

    Time frame · At first dose (visit 4, day 2),after 12 weeks (visit 9, day 85)

  5. Area under gallbladder EF-time curve

    Time frame · At 12 weeks (visit 9)

  6. Area under the paracetamol concentration-time curve

    Time frame · At first dose (visit 4,day 2) after 12 weeks (visit 9, day 85)

  7. Area under the paracetamol concentration-time curve

    Time frame · At 12 weeks (visit 9)

  8. 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)

  9. Incremental area under the plasma glucose concentration-time curve

    Time frame · At 12 weeks (visit 9)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

7 results

Effects of liraglutide on gallbladder emptying: A randomized, placebo-controlled trial in adults with overweight or obesity.

Nexøe-Larsen et al. 2018Diabetes, obesity & metabolismcited by 42

PMID 29892986PMC6220792DOI 10.1111/dom.13420PUB-29892986

Free to read · publisher termsCC BY-NC7 results
Read at sourceSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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