NCT00422058

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 564 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metabolism and Nutrition Disorder
• Obesity

Interventions

Type	Name	Description
DRUG	liraglutide	Injected s.c. (under the skin) once daily
DRUG	orlistat	120 mg capsule. Administered thrice daily
DRUG	placebo	Injected s.c. (under the skin) once daily

Timeline

• Start date: 2007-01-10
• Primary completion: 2007-09-13
• Completion: 2009-04-30
• First posted: 2007-01-15
• Last updated: 2017-11-01
• Results posted: 2010-10-28

Locations

19 sites across 8 countries: Belgium, Czechia, Denmark, Finland, Netherlands, Spain, Sweden, United Kingdom