Clinical trial NCT00422058: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-01-15
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change From Baseline in Body Weight at Week 20
timeFrame: Week 0, week 20
Secondary outcomes:
measure: Mean Change From Baseline in Body Weight at Week 104
timeFrame: Week 0, week 104
measure: Change From Baseline in Fasting Plasma Glucose at Week 20
timeFrame: Week 0, week 20
measure: Change From Baseline in Fasting Plasma Glucose at Week 104
timeFrame: Week 0, week 104
measure: Change From Baseline in Fasting Insulin at Week 20
timeFrame: Week 0, week 20
measure: Change From Baseline in Fasting Insulin at Week 104
timeFrame: Week 0, week 104
measure: Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
timeFrame: Week 0, week 20
measure: Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
timeFrame: Week 0, week 104
measure: Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20
timeFrame: Week 0, week 20
measure: Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104
timeFrame: Week 0, week 104
measure: Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20
timeFrame: Week 0, week 20
measure: Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104
timeFrame: Week 0, week 104
measure: Change From Baseline in Fibrinogen at Week 20
timeFrame: Week 0, week 20
measure: Change From Baseline in Fibrinogen at Week 104
timeFrame: Week 0, week 104
measure: Change From Baseline in Adiponectin at Week 20
timeFrame: Week 0, week 20
measure: Change From Baseline in Adiponectin at Week 104
timeFrame: Week 0, week 104
measure: Change From Baseline in Waist Circumference at Week 20
timeFrame: Week 0, week 20
measure: Change From Baseline in Waist Circumference at Week 104
timeFrame: Week 0, week 104
measure: Change From Baseline in Blood Pressure at Week 20
timeFrame: Week 0, week 20
measure: Change From Baseline in Blood Pressure at Week 104
timeFrame: Week 0, week 104
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Novo Nordisk Investigational Site
city: Praha 1
country: Czechia
facility: Novo Nordisk Investigational Site
city: Praha 2
country: Czechia
facility: Novo Nordisk Investigational Site
city: Frederiksberg C
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hvidovre
country: Denmark
facility: Novo Nordisk Investigational Site
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Kuopio
country: Finland
facility: Novo Nordisk Investigational Site
city: Oulu
country: Finland
facility: Novo Nordisk Investigational Site
city: Almere
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Pamplona
country: Spain
facility: Novo Nordisk Investigational Site
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Glasgow
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Luton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Norwich
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Astrup A, Carraro R, Finer N, Harper A, Kunesova M, Lean ME, Niskanen L, Rasmussen MF, Rissanen A, Rossner 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 analog, liraglutide. Int J Obes (Lond). 2012 Jun;36(6):843-54. doi: 10.1038/ijo.2011.158. Epub 2011 Aug 16.
citation: Astrup A, Rossner 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(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23.
citation: Lean ME, Carraro R, Finer N, Hartvig H, Lindegaard ML, Rossner 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. Int J Obes (Lond). 2014 May;38(5):689-97. doi: 10.1038/ijo.2013.149. Epub 2013 Aug 14.
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 Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4.
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 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.
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 obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.