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

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.

Study Type: Interventional

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

Study Primary Completion Date: April 2009

Intervention(s) in this Clinical Trial

• Drug: placebo
  • placebo, s.c. injection volume of 100 mcg
• Drug: orlistat
  • 120 mg capsule. Adminstered thrice daily
• Drug: liraglutide
  • 3.0 mg s.c. injected once daily.
• Drug: liraglutide
  • 2.4 mg s.c. injected once daily.
• Drug: liraglutide
  • 1.8 mg s.c. injected once daily.
• Drug: liraglutide
  • 1.2 mg s.c. injected once daily.
• Drug: placebo
  • placebo, s.c. injection volume of 200 mcg
• Drug: placebo
  • placebo, s.c. injection volume of 300 mcg
• Drug: placebo
  • placebo, s.c. injection volume of 400 mcg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Experimental: B
• Experimental: C
• Experimental: D
• Placebo Comparator: E1
• Placebo Comparator: E2
• Placebo Comparator: E3
• Placebo Comparator: E4
• Active Comparator: F

Primary Measures

• Body weight loss
  • Time Frame: after 32 and 84 weeks of treatment
    Safety Issue?: No

Secondary Measures

• Glucose metabolism
  • Time Frame: after 84 weeks of treatment
    Safety Issue?: No
• Cardiovascular risk factors
  • Time Frame: after 84 weeks of treatment
    Safety Issue?: Yes
• Body composition
  • Time Frame: after 84 weeks of treatment
    Safety Issue?: No

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

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

Lead Sponsor: Novo Nordisk

Overall Clinical Trial Officials and Contacts

Mads F. Rasmussen, MD, PhD Study Director Novo Nordisk A/S  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00480909

Study ID Number: NN8022-1807 ext.

ClinicalTrials.gov Identifier: NCT00480909

Health Authority: Denmark: Danish Medicines Agency

Clinical Trials at Novo Nordisk