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):
Intervention(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
- Time Frame: after 20 weeks of treatment
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
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