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. - Tabular View

Tracking Information

First Received Date ^ICMJE

May 30, 2007

Last Updated Date

November 5, 2009

Start Date ^ICMJE

June 2007

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Body weight loss [ Time Frame: after 32 and 84 weeks of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Long term body weight loss [ Time Frame: after 84 weeks of treatment ]

Change History

Complete list of historical versions of study NCT00480909 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Glucose metabolism [ Time Frame: after 84 weeks of treatment ] [ Designated as safety issue: No ]
Cardiovascular risk factors [ Time Frame: after 84 weeks of treatment ] [ Designated as safety issue: Yes ]
Body composition [ Time Frame: after 84 weeks of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Glucose metabolism
Cardiovascular risk factors
Body composition

Descriptive Information

Brief Title ^ICMJE

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.

Official Title ^ICMJE

The Long Term Efficacy of Liraglutide on Body Weight in Obese Subjects Without Diabetes: An Extension to Trial NN8022-1807

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Drug: placebo
Drug: orlistat
Drug: liraglutide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

398

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Completion of initial 20 week blinded study: Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes (identifier NCT00422058)
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% self-reported 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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Czech Republic, Denmark, Finland, Netherlands, Spain, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00480909

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

NN8022-1807 ext., EudraCT No: 2006-004481-13

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Mads F. Rasmussen, MD, PhD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP