Status:
COMPLETED
Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Metabolism and Nutrition Disorder
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ove...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) of either 30 kg/m\^2 or more or BMI of less than 30 kg/m\^2 to 27 kg/m\^2 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
- Diagnosis of type 1 or type 2 diabetes
- Previous treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (including liraglutide or exenatide), within the last 3 months
- Visit 1 thryoid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L
- 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 (Patient Health Questionnaire-9) score 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
Key Trial Info
Start Date :
October 30 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT00781937
Start Date
October 30 2008
End Date
September 1 2010
Last Update
November 1 2017
Active Locations (37)
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1
Novo Nordisk Investigational Site
Goodyear, Arizona, United States, 85395
2
Novo Nordisk Investigational Site
Peoria, Arizona, United States, 85381
3
Novo Nordisk Investigational Site
Huntington Beach, California, United States, 92648
4
Novo Nordisk Investigational Site
Montclair, California, United States, 91763