The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes - Full Text View

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00422058

Purpose

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.

Condition	Intervention	Phase
Obesity	Drug: liraglutide Drug: orlistat Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Obesity

Drug Information available for: Orlistat Liraglutide

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Mean Change From Baseline in Body Weight at Week 20 [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
Calculated as mean body weight at week 20 - baseline

Secondary Outcome Measures:

Mean Change From Baseline in Body Weight at Week 104 [ Time Frame: Week 0, week 104 ] [ Designated as safety issue: No ]
Calculated as mean body weight at week 104 - baseline
Change From Baseline in Fasting Plasma Glucose at Week 20 [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
Calculated as mean fasting plasma glucose at week 20 - baseline
Change From Baseline in Fasting Plasma Glucose at Week 104 [ Time Frame: Week 0, week 104 ] [ Designated as safety issue: No ]
Calculated as mean fasting plasma glucose at week 104 - baseline
Change From Baseline in Fasting Insulin at Week 20 [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
Calculated as mean fasting insulin at week 20 - baseline
Change From Baseline in Fasting Insulin at Week 104 [ Time Frame: Week 0, week 104 ] [ Designated as safety issue: No ]
Calculated as mean fasting insulin at week 104 - baseline
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 [ Time Frame: Week 0, week 104 ] [ Designated as safety issue: No ]
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: Yes ]
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 hsCRP (Highly Sensitive C-reactive Protein) at Week 104 [ Time Frame: Week 0, week 104 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Week 0, week 104 ] [ Designated as safety issue: Yes ]
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 Fibrinogen at Week 20 [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: Yes ]
Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk
Change From Baseline in Fibrinogen at Week 104 [ Time Frame: Week 0, week 104 ] [ Designated as safety issue: Yes ]
Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk
Change From Baseline in Adiponectin at Week 20 [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Week 0, week 104 ] [ Designated as safety issue: Yes ]
Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk
Change From Baseline in Waist Circumference at Week 20 [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
Calculated as mean waist circumference at week 20-baseline.
Change From Baseline in Waist Circumference at Week 104 [ Time Frame: Week 0, week 104 ] [ Designated as safety issue: No ]
Calculated as mean waist circumference at week 104-baseline.
Change From Baseline in Blood Pressure at Week 20 [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
Calculated as mean blood pressure at week 20-baseline.
Change From Baseline in Blood Pressure at Week 104 [ Time Frame: Week 0, week 104 ] [ Designated as safety issue: No ]
Calculated as mean blood pressure at week 104-baseline.

Enrollment:	564
Study Start Date:	January 2007
Study Completion Date:	April 2009
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Lira placebo/Lira 2.4 mg/Lira 3.0 mg 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 Injected s.c. (under the skin) once daily
Experimental: Lira 1.2 mg/Lira 3.0 mg 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 Injected s.c. (under the skin) once daily
Experimental: Lira 1.8 mg/Lira 3.0 mg 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 Injected s.c. (under the skin) once daily
Experimental: Lira 2.4 mg/Lira 3.0 mg 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 Injected s.c. (under the skin) once daily
Experimental: Liraglutide 3.0 mg 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 Injected s.c. (under the skin) once daily Drug: placebo Injected s.c. (under the skin) once daily
Active Comparator: 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)	Drug: orlistat 120 mg capsule. Administered thrice daily

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422058

Locations

Belgium

Edegem, Antwerp, Belgium
Czech Republic

Prague, Czech Republic
Denmark

Copenhagen, Denmark

Frederiksberg, Denmark
Finland

Helsinki, Finland
Netherlands

Almere, Netherlands
Spain

Barcelona, Spain
Sweden

Stockholm, Sweden
United Kingdom

Glasgow, United Kingdom

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Mads F. Rasmussen, MD, PhD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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(9701):1606-16. Epub 2009 Oct 23.

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00422058 History of Changes
Obsolete Identifiers:	NCT00480909
Other Study ID Numbers:	NN8022-1807, 2006-004481-13
Study First Received:	January 12, 2007
Results First Received:	April 27, 2010
Last Updated:	February 14, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory; Denmark: Danish Medicines Agency; Finland: Finnish Medicines Agency; Czech Republic: State Institute for Drug Control; Spain: Spanish Agency for Medicines; Belgium: FPS of Public Health, Directorate General for the protection of Public Health: Medicines; Sweden: Medical Products Agency; Netherlands: Medicines Evaluation Board, Dutch Health Care Inspectorate

Additional relevant MeSH terms:

Body Weight
Obesity
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Orlistat
Glucagon-Like Peptide 1
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012