The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes: An Extension to Trial NN8022-1807 - Full Text View

Purpose

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.

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

MedlinePlus related topics:

Diabetes Obesity Weight Control

ChemIDplus related topics:

Liraglutide Orlistat

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	310
Study Start Date:	June 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: liraglutide 1.2 mg s.c. injected once daily.
B: Experimental	Drug: liraglutide 1.8 mg s.c. injected once daily.
C: Experimental	Drug: liraglutide 2.4 mg s.c. injected once daily.
D: Experimental	Drug: liraglutide 3.0 mg s.c. injected once daily.
E1: Placebo Comparator	Drug: placebo placebo, s.c. injection volume of 100 mcg
E2: Placebo Comparator	Drug: placebo placebo, s.c. injection volume of 200 mcg
E3: Placebo Comparator	Drug: placebo placebo, s.c. injection volume of 300 mcg
E4: Placebo Comparator	Drug: placebo placebo, s.c. injection volume of 400 mcg
F: Active Comparator	Drug: orlistat 120 mg capsule. Adminstered thrice daily

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480909

Locations

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	Mads F. Rasmussen, MD, PhD	Novo Nordisk A/S

More Information

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN8022-1807 ext., EudraCT No: 2006-004481-13
First Received:	May 30, 2007
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00480909
Health Authority:	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; Sweden: Medical Products Agency; Netherlands: Medicines Evaluation Board, Dutch Health Care Inspectorate

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Orlistat

Diabetes Mellitus

Nutrition Disorders

Overweight

Overnutrition

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00480909