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

This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide.

Trial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes: A 20-week Randomised, Double-blind, Placebo-controlled, Six Armed Parallel Group, Multi-centre, Multinational Trial With an Open Label Orlistat Comparator Arm and With an 84-week Extension Period
Enrollment: 564
Study Start Date: January 2007
Study Completion Date: April 2009
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

Arms:
- Placebo Comparator: Lira placebo/Lira 2.4 mg/Lira 3.0 mg
- Experimental: Lira 1.2 mg/Lira 3.0 mg
- Experimental: Lira 1.8 mg/Lira 3.0 mg
- Experimental: Lira 2.4 mg/Lira 3.0 mg
- Experimental: Liraglutide 3.0 mg
- Active Comparator: Orlistat