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

Phase 2

Completed

Conditions: Metabolism and Nutrition Disorder
Obesity

Interventions: Drug: placebo
Drug: liraglutide
Drug: orlistat

Registration Number: NCT00422058

Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 564

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lira placebo/Lira 2.4 mg/Lira 3.0 mg	placebo	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)
Lira 1.8 mg/Lira 3.0 mg	liraglutide	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)
Liraglutide 3.0 mg	placebo	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)
Lira 1.2 mg/Lira 3.0 mg	liraglutide	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)
Lira 2.4 mg/Lira 3.0 mg	liraglutide	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)
Orlistat	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)
Liraglutide 3.0 mg	liraglutide	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)

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Body Weight at Week 20	Week 0, week 20	Calculated as mean body weight at week 20 - baseline

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose at Week 104	Week 0, week 104	Calculated as mean fasting plasma glucose at week 104 - baseline
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20	Week 0, week 20	Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk
Change From Baseline in Fibrinogen at Week 104	Week 0, week 104	Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk
Change From Baseline in Waist Circumference at Week 104	Week 0, week 104	Calculated as mean waist circumference at week 104-baseline.
Change From Baseline in Fasting Plasma Glucose at Week 20	Week 0, week 20	Calculated as mean fasting plasma glucose at week 20 - baseline
Change From Baseline in Fasting Insulin at Week 20	Week 0, week 20	Calculated as mean fasting insulin at week 20 - baseline
Change From Baseline in Fasting Insulin at Week 104	Week 0, week 104	Calculated as mean fasting insulin at week 104 - baseline
Change From Baseline in Adiponectin at Week 20	Week 0, week 20	Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk
Change From Baseline in Adiponectin at Week 104	Week 0, week 104	Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20	Week 0, week 20	Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104	Week 0, week 104	Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20	Week 0, week 20	Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104	Week 0, week 104	Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk
Change From Baseline in Waist Circumference at Week 20	Week 0, week 20	Calculated as mean waist circumference at week 20-baseline.
Change From Baseline in Blood Pressure at Week 20	Week 0, week 20	Calculated as mean blood pressure at week 20-baseline.
Change From Baseline in Blood Pressure at Week 104	Week 0, week 104	Calculated as mean blood pressure at week 104-baseline.
Mean Change From Baseline in Body Weight at Week 104	Week 0, week 104	Calculated as mean body weight at week 104 - baseline
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104	Week 0, week 104	Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline
Change From Baseline in Fibrinogen at Week 20	Week 0, week 20	Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk