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

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:

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

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

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

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: National Agency for Medicines; 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 November 09, 2009