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

This study has been completed.

First Received: January 12, 2007 Last Updated: June 11, 2009 History of Changes

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

Purpose

This trial is conducted in Europe. The purpose of the trial is to investigate the efficacy of liraglutide to induce body weight loss.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Obesity Weight Control

Drug Information available for: Orlistat Liraglutide

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Body weight loss [ Time Frame: after 20 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Glucose metabolism [ Designated as safety issue: No ]
Cardiovascular risk factors [ Designated as safety issue: No ]
Body composition [ Designated as safety issue: No ]

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 National Clinical Trials Identifier (NCT ID):

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:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN8022-1807, EudraCT No: 2006-004481-13
Study First Received:	January 12, 2007
Last Updated:	June 11, 2009
ClinicalTrials.gov Identifier:	NCT00422058 History of Changes
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
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on February 08, 2010