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

• Status: Completed
• Trial end date: 2009-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide; Orlistat

Criteria

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