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.

This study has been completed.

First Received: May 30, 2007 Last Updated: November 5, 2009 History of Changes

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

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

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

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 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 ]

Enrollment:	398
Study Start Date:	June 2007
Study Completion Date:	April 2009
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

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

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

Belgium

Edegem, Antwerp, Belgium
Czech Republic

Prague, Czech Republic
Denmark

Frederiksberg, Denmark
Finland

Helsinki, Finland
Netherlands

Almere, Netherlands
Spain

Barcelona, Spain
Sweden

Stockholm, Sweden
United Kingdom, Bedfordshire

Luton, Bedfordshire, United Kingdom, LU4 0DZ

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 ext., EudraCT No: 2006-004481-13
Study First Received:	May 30, 2007
Last Updated:	November 5, 2009
ClinicalTrials.gov Identifier:	NCT00480909 History of Changes
Health Authority:	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; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Obesity
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Overweight
Enzyme Inhibitors
Hormones
Pharmacologic Actions
Glucagon-Like Peptide 1

Body Weight
Signs and Symptoms
Anti-Obesity Agents
Orlistat
Therapeutic Uses
Incretins
Nutrition Disorders
Overnutrition
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009