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Trial · Interventional

CompletedPhase 1Registry data

A Trial to Assess the Effect of Liraglutide on Gastric Emptying in Healthy Obese Volunteers

NCTNCT00978393 (opens ClinicalTrials.gov in a new tab)Other idNN8022-3630Other id2008-003228-44Other idU1111-1111-9119Other id2008
Open at ClinicalTrials.govAsk about this trial

Overview

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

Netherlands

Start
16 Sept 2009
Primary completion
8 Jun 2011
Completion
8 Jun 2011
First posted
16 Sept 2009 (estimated)
Last update posted
27 Jul 2017
Conditions
Metabolism and Nutrition Disorder · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 1

    A Trial to Assess the Effect of Liraglutide on Gastric Emptying in Healthy Obese Volunteers

    NCT00978393

    16 Sept 2009 to 8 Jun 2011

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 clinical trial is to investigate the effect of liraglutide on gastric emptying, energy expenditure and appetite, and to evaluate liraglutide pharmacokinetics in non-diabetic obese volunteers. The trial is designed as a two-period, six-sequenced, crossover trial where the trial participant will enter two treatment periods with a wash-out period of 6-8 weeks.

Interventions

  • liraglutideDrug
  • liraglutideDrug
  • liraglutideDrug
  • liraglutideDrug
  • liraglutideDrug
  • liraglutideDrug

Arms6

  • Experimental

    A

  • Experimental

    B

  • Experimental

    C

  • Experimental

    D

  • Experimental

    E

  • Experimental

    F

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Gastric emptying measured as AUC0-300min of paracetamol postprandial concentration profiles during a standardised meal test with intake of 1.5 g paracetamol

    Time frame · after 35 days of treatment

Secondary outcomes(1)

  1. Gastric emptying: Cmax and AUC0-60min/AUC0-300min of paracetamol postprandial concentration profiles

    Time frame · after 35 days of treatment

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 · 2014

20 results

Effects of the once-daily GLP-1 analog liraglutide on gastric emptying, glycemic parameters, appetite and energy metabolism in obese, non-diabetic adults.

van Can et al. 2014International journal of obesity (2005)cited by 387

PMID 23999198PMC4052428DOI 10.1038/ijo.2013.162PUB-23999198

Free to read · publisher termsCC BY-NC-ND20 results
Read at sourceSee results (20)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Body Mass Index (BMI) between 30.0-40.0 kg/m2 * Stable body weight (below 5 kg body weight change during past 3 month) * Fasting plasma glucose below 7.0 mmol/L Exclusion Criteria: * Presence or history of cancer or any clinically significant cardiac, metabolic, renal, gastrointestinal, hepatic, endocrine, dermatological, haematological, or psychiatric diseases or disorders, considered by the Investigator to have influence of the results of this trial * History of chronic pancreatitis or idiopathic acute pancreatitis * Current or history of treatment with medications that may cause significant weight gain, within 12 months prior to screening * Use of weight lowering pharmacotherapy within the last 3 months prior to trial start * Previous or scheduled (during the trial period) surgical treatment for obesity * Diagnosed type 1 or type 2 diabetes * Smoking habitually as judged by the Investigator * Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods if not sterile or post-menopausal

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