Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Metabolism and Nutrition Disorder; Obesity

Treatments: Drug: liraglutide; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00781937

NN8022-1923

Details and patient eligibility

About

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).

Enrollment: 422 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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422 participants in 2 patient groups, including a placebo group

Lira 3.0 mg

Experimental group

Description:

A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached

Treatment:

Drug: liraglutide

Placebo

Placebo Comparator group

Description:

A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period

Treatment:

Drug: placebo