Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Patients - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00781937

Purpose

This trial is conducted in North America. The aim of this clinical trial is to evaluate the potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as well as in overweight subjects who have medical problems such as hypertension (high blood pressure) or dyslipidaemia (an abnormal amount of lipids in the blood)

Condition	Intervention	Phase
Obesity	Drug: liraglutide Drug: placebo	Phase III

MedlinePlus related topics: Diets Obesity Weight Control

Drug Information available for: Liraglutide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Liraglutide on Long-Term Weight Maintenance Following Weight Loss Induced by a 12 Week Low Calorie Diet in Obese Subjects; A 52 Week Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multi-Centre Trial With a 12 Week Follow-up Period

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Percentage of subjects who maintain their run-in fasting weight loss after 52 weeks of treatment [ Time Frame: across approx. 78 weeks ] [ Designated as safety issue: No ]
Mean percentage change in fasting body weight from trial start [ Time Frame: across approx. 78 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects with weight loss of between 5% and 10% of fasting body weight at 52 weeks vs. trial start [ Time Frame: across approx. 78 weeks ] [ Designated as safety issue: No ]
Percentage of subjects with weight regain (fasting) from trial start of between 5% and 10% [ Time Frame: across approx. 78 weeks ] [ Designated as safety issue: No ]
Percentage of subjects with greater than 50% and greater than 75% of fasting run-in weight loss maintained at week 52 [ Time Frame: across approx. 78 weeks ] [ Designated as safety issue: No ]
Change in fasting weight for subjects completing the main trial and entering the follow-up period [ Time Frame: From baseline to end-of-treatment and to end of 12 week follow-up period ] [ Designated as safety issue: No ]
Change in cardiovascular risk factors [ Time Frame: across approx. 78 weeks ] [ Designated as safety issue: Yes ]
Vital signs (blood pressure and pulse) [ Time Frame: across approx. 78 weeks ] [ Designated as safety issue: Yes ]
Fasting lipid profile [ Time Frame: across approx. 78 weeks ] [ Designated as safety issue: No ]
Cardiovascular biomarkers [ Time Frame: across approx. 78 weeks ] [ Designated as safety issue: No ]
Metabolic syndrome status (ATP III) [ Time Frame: across approx. 78 weeks ] [ Designated as safety issue: No ]
Waist circumference and BMI (Body Mass Index) [ Time Frame: across approx. 78 weeks ] [ Designated as safety issue: No ]
Change in parameters of glycaemic control (HOMA, FPG, fasting serum insulin, and glycosylated haemoglobin (HbA1c)) [ Time Frame: across approx. 78 weeks ] [ Designated as safety issue: No ]
Change in concomitant medications: lowering of dose or discontinuation of anti-hypertensive medications and lipid lowering medications [ Time Frame: across approx. 78 weeks ] [ Designated as safety issue: No ]
Binge eating assessment [ Time Frame: across approx. 78 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	420
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: liraglutide Liraglutide 3.0 mg per day administered in a 6.0 mg/mL, 3 mL FlexPen® for subcutaneous (s.c.) injection, once daily
B: Placebo Comparator	Drug: placebo Liraglutide placebo 3 mL FlexPen® for subcutaneous (s.c.) injection, once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Body Mass Index (BMI) of either 30 kg/m2 or more or BMI of 27 kg/m2 or more with presence of co-morbidities
Stable body weight during the previous 3 months (less than 5 kg self-reported weight change)
Previously undergone dietary weight loss and was not able to maintain reduced weight

Exclusion Criteria:

Diagnosis of type 1 or type 2 diabetes
Previous treatment with GLP-1 receptor agonists (including liraglutide or exenatide), within the last 3 months
Untreated hypothyroidism/hyperthyroidism
History of chronic pancreatitis or idiopathic acute pancreatitis
Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome)
Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
Current participation in an organized diet reduction program (or within the last 3 months)
Currently using or have used within three months before this trial: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phenteremine, or metformin
Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry)
History of major depressive disorder or a PHQ-9 of more than 15 within the last 2 years or history of other severe psychiatric disorders or diagnosis of an eating disorder
Subjects with a lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781937

Show 37 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Paula M. Hale, MD

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:	NN8022-1923
Study First Received:	October 28, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00781937 History of Changes
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 07, 2009