The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes. An Extension to Trial NN8022-1807

Condition(s) targeted: Obesity

Intervention: placebo (Drug); orlistat (Drug); liraglutide (Drug); liraglutide (Drug); liraglutide (Drug); liraglutide (Drug); placebo (Drug); placebo (Drug); placebo (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Mads F. Rasmussen, MD, PhD, Study Director, Affiliation: Novo Nordisk A/S

This trial is conducted in Europe.

The purpose of the trial is to investigate the long term efficacy of liraglutide to induce body weight loss.

Official title: The Long Term Efficacy of Liraglutide on Body Weight in Obese Subjects Without Diabetes. An Extension to Trial NN8022-1807

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Body weight loss

Secondary outcome:

Glucose metabolism

Cardiovascular risk factors

Body composition

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Completion of initial 20 week blinded study: Effect of Liraglutide on Body Weight in

Obese Subjects Without Diabetes (identifier NCT00422058)

- 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% self-reported 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

Brussels, Belgium

Prague, Czech Republic

Frederiksberg, Denmark

Helsinki, Finland

Almere, Netherlands

Barcelona, Spain

Stockholm, Sweden

Clinical Trials at Novo Nordisk

Starting date: June 2007
Ending date: April 2009
Last updated: May 6, 2008