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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422058
• Other study ID #: NN8022-1807
• Secondary ID: 2006-004481-13
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2007
• Last updated: September 29, 2017
• Start date: January 10, 2007
• Est. completion date: April 30, 2009

Study information

• Verified date: September 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00480909

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Body Weight
• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity

Intervention

Drug:
• liraglutide
Injected s.c. (under the skin) once daily
• orlistat
120 mg capsule. Administered thrice daily
• placebo
Injected s.c. (under the skin) once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Belgium,  Czechia,  Denmark,  Finland,  Netherlands,  Spain,  Sweden,  United Kingdom, 

References & Publications (6)

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

Outcome

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

External Links

•   Clinical Trials at Novo Nordisk