Obesity Clinical Trial
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
Verified date | September 2017 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 564 |
Est. completion date | April 30, 2009 |
Est. primary completion date | September 13, 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Novo Nordisk Investigational Site | Edegem | |
Czechia | Novo Nordisk Investigational Site | Praha 1 | |
Czechia | Novo Nordisk Investigational Site | Praha 2 | |
Denmark | Novo Nordisk Investigational Site | Århus C | |
Denmark | Novo Nordisk Investigational Site | Frederiksberg C | |
Denmark | Novo Nordisk Investigational Site | Hvidovre | |
Finland | Novo Nordisk Investigational Site | Helsinki | |
Finland | Novo Nordisk Investigational Site | Kuopio | |
Finland | Novo Nordisk Investigational Site | Oulu | |
Netherlands | Novo Nordisk Investigational Site | Almere | |
Spain | Novo Nordisk Investigational Site | Barcelona | |
Spain | Novo Nordisk Investigational Site | Madrid | |
Spain | Novo Nordisk Investigational Site | Madrid | |
Spain | Novo Nordisk Investigational Site | Pamplona | |
Sweden | Novo Nordisk Investigational Site | Malmö | |
Sweden | Novo Nordisk Investigational Site | Stockholm | |
United Kingdom | Novo Nordisk Investigational Site | Glasgow | |
United Kingdom | Novo Nordisk Investigational Site | Luton | |
United Kingdom | Novo Nordisk Investigational Site | Norwich |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Belgium, Czechia, Denmark, Finland, Netherlands, Spain, Sweden, United Kingdom,
Astrup A, Carraro R, Finer N, Harper A, Kunesova M, Lean ME, Niskanen L, Rasmussen MF, Rissanen A, Rössner S, Savolainen MJ, Van Gaal L; NN8022-1807 Investigators. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 — View Citation
Astrup A, Rössner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374 — View Citation
Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or — View Citation
Lean ME, Carraro R, Finer N, Hartvig H, Lindegaard ML, Rössner S, Van Gaal L, Astrup A; NN8022-1807 Investigators. Tolerability of nausea and vomiting and associations with weight loss in a randomized trial of liraglutide in obese, non-diabetic adults. In — View Citation
O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3 — View Citation
Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Po — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Change From Baseline in Body Weight at Week 20 | Calculated as mean body weight at week 20 - baseline | Week 0, week 20 | |
Secondary | Mean Change From Baseline in Body Weight at Week 104 | Calculated as mean body weight at week 104 - baseline | Week 0, week 104 | |
Secondary | Change From Baseline in Fasting Plasma Glucose at Week 20 | Calculated as mean fasting plasma glucose at week 20 - baseline | Week 0, week 20 | |
Secondary | Change From Baseline in Fasting Plasma Glucose at Week 104 | Calculated as mean fasting plasma glucose at week 104 - baseline | Week 0, week 104 | |
Secondary | Change From Baseline in Fasting Insulin at Week 20 | Calculated as mean fasting insulin at week 20 - baseline | Week 0, week 20 | |
Secondary | Change From Baseline in Fasting Insulin at Week 104 | Calculated as mean fasting insulin at week 104 - baseline | Week 0, week 104 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Change From Baseline in Waist Circumference at Week 20 | Calculated as mean waist circumference at week 20-baseline. | Week 0, week 20 | |
Secondary | Change From Baseline in Waist Circumference at Week 104 | Calculated as mean waist circumference at week 104-baseline. | Week 0, week 104 | |
Secondary | Change From Baseline in Blood Pressure at Week 20 | Calculated as mean blood pressure at week 20-baseline. | Week 0, week 20 | |
Secondary | Change From Baseline in Blood Pressure at Week 104 | Calculated as mean blood pressure at week 104-baseline. | Week 0, week 104 |
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