The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes

This trial is conducted in Europe. The purpose of the trial is to investigate the efficacy of liraglutide to induce body weight loss...

Date First Received: January 12, 2007

Last Updated: June 11, 2009

Verified by: Novo Nordisk, May 2009

Clinical Trial Phase: Phase 2 | Start Date: January 2007

Overall Status: Completed

Estimated Enrollment: 564

Brief Summary

Official Title: “Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes”

Condition Keyword(s):

This trial is conducted in Europe. The purpose of the trial is to investigate the efficacy of liraglutide to induce body weight loss.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2009

Intervention(s) in this Clinical Trial

  • Drug: liraglutide
  • Drug: orlistat

Outcome Measures for this Clinical Trial

Primary Measures

  • Body weight loss
    • Time Frame: after 20 weeks of treatment
      Safety Issue?: No

Secondary Measures

  • Glucose metabolism
    • Safety Issue?: No
  • Cardiovascular risk factors
    • Safety Issue?: No
  • Body composition
    • Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Body Mass Index (BMI) greater than or equal to 30.0 or lesser than or equal to 40.0 kg/m2
  • Stable body weight (less than 5% selfreported change within the last 3 months)

Exclusion Criteria:

  • Obesity induced by drug treatment
  • Use of approved drugs for weight lowering intervention (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to entering trial
  • Type 1 or type 2 diabetes

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Sponsor Information

Lead Sponsor: Novo Nordisk

Overall Clinical Trial Officials and Contacts

Mads F. Rasmussen, MD, PhD Study Director Novo Nordisk  

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00422058

Study ID Number: NN8022-1807

ClinicalTrials.gov Identifier: NCT00422058

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory

Clinical Trials at Novo Nordisk

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