Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Nutrition Disorders; Weight Loss
Intervention: liraglutide; placebo
Intervention description: Liraglutide 3.0 mg per day administered in a 6.0 mg/mL, 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily; Liraglutide placebo 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 422.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 overweight subjects who have medical problems such as hypertension (high blood
      pressure) or dyslipidaemia (an abnormal amount of lipids in the blood).

      Trial has following trial periods: A 12-week run-in period (from week -12 to week 0) followed
      by a 56-week main trial period (weeks 0-56) and a 12-week follow-up period (weeks 56-68).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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