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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
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* Drug: liraglutide
* Drug: orlistat
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lira placebo/Lira 2.4 mg/Lira 3.0 mg<br>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) | Drug: placebo<br>* Injected s.c. (under the skin) once daily<br>|
| Experimental: Lira 1.2 mg/Lira 3.0 mg<br>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) | Drug: liraglutide<br>* Injected s.c. (under the skin) once daily<br>|
| Experimental: Lira 1.8 mg/Lira 3.0 mg<br>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) | Drug: liraglutide<br>* Injected s.c. (under the skin) once daily<br>|
| Experimental: Lira 2.4 mg/Lira 3.0 mg<br>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) | Drug: liraglutide<br>* Injected s.c. (under the skin) once daily<br>|
| Experimental: Liraglutide 3.0 mg<br>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) | Drug: liraglutide<br>* Injected s.c. (under the skin) once daily<br>Drug: placebo<br>* Injected s.c. (under the skin) once daily<br>|
| Active Comparator: Orlistat<br>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) | Drug: orlistat<br>* 120 mg capsule. Administered thrice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Body Weight at Week 20 | Calculated as mean body weight at week 20 - baseline | Week 0, week 20 | 

Secondary Outcome Measures

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