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  

Information obtained from ClinicalTrials.gov on July 02, 2009

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