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

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Lira placebo/Lira 2.4 mg/Lira 3.0 mg
  • Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
• Experimental: Lira 1.2 mg/Lira 3.0 mg
  • Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
• Experimental: Lira 1.8 mg/Lira 3.0 mg
  • Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
• Experimental: Lira 2.4 mg/Lira 3.0 mg
  • Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
• Experimental: Liraglutide 3.0 mg
  • Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
• Active Comparator: Orlistat
  • Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)

Primary Measures

• Mean Change From Baseline in Body Weight at Week 20
  • Time Frame: Week 0, week 20
    Safety Issue?: No

Secondary Measures

• Mean Change From Baseline in Body Weight at Week 104
  • Time Frame: Week 0, week 104
    Safety Issue?: No
• Change From Baseline in Fasting Plasma Glucose at Week 20
  • Time Frame: Week 0, week 20
    Safety Issue?: No
• Change From Baseline in Fasting Plasma Glucose at Week 104
  • Time Frame: Week 0, week 104
    Safety Issue?: No
• Change From Baseline in Fasting Insulin at Week 20
  • Time Frame: Week 0, week 20
    Safety Issue?: No
• Change From Baseline in Fasting Insulin at Week 104
  • Time Frame: Week 0, week 104
    Safety Issue?: No
• Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
  • Time Frame: Week 0, week 20
    Safety Issue?: No
• Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
  • Time Frame: Week 0, week 104
    Safety Issue?: No
• Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20
  • Time Frame: Week 0, week 20
    Safety Issue?: Yes
• Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104
  • Time Frame: Week 0, week 104
    Safety Issue?: Yes
• Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20
  • Time Frame: Week 0, week 20
    Safety Issue?: Yes
• Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104
  • Time Frame: Week 0, week 104
    Safety Issue?: Yes
• Change From Baseline in Fibrinogen at Week 20
  • Time Frame: Week 0, week 20
    Safety Issue?: Yes
• Change From Baseline in Fibrinogen at Week 104
  • Time Frame: Week 0, week 104
    Safety Issue?: Yes
• Change From Baseline in Adiponectin at Week 20
  • Time Frame: Week 0, week 20
    Safety Issue?: Yes
• Change From Baseline in Adiponectin at Week 104
  • Time Frame: Week 0, week 104
    Safety Issue?: Yes
• Change From Baseline in Waist Circumference at Week 20
  • Time Frame: Week 0, week 20
    Safety Issue?: No
• Change From Baseline in Waist Circumference at Week 104
  • Time Frame: Week 0, week 104
    Safety Issue?: No
• Change From Baseline in Blood Pressure at Week 20
  • Time Frame: Week 0, week 20
    Safety Issue?: No
• Change From Baseline in Blood Pressure at Week 104
  • Time Frame: Week 0, week 104
    Safety Issue?: No

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

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?: No

Lead Investigator: Novo Nordisk Industry

Overall Clinical Trial Officials and Contacts

Mads F. Rasmussen, MD, PhD Study Director Novo Nordisk  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00422058

Study ID Number: NN8022-1807

ClinicalTrials.gov Identifier: NCT00422058

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory

Clinical Trials at Novo Nordisk