We performed a multicenter, randomized, double-blind, placebo-controlled 28-week trial. 300 non-diabetic obese subjects or overweight subjects with co-morbidities were randomly assigned. Eligible participants were randomized 2:1 to once-daily subcutaneous injections of either liraglutide or placebo. The primary outcome is to investigate the safety, tolerability from baseline to end of treatment.
We performed a multicenter, randomized, double-blind, placebo-controlled 28-week trial. 300 individuals (18-75 years of age, body-mass index ≥30 kg/m2 or BMI 27-30kg/m2 accompanied by at least one weight-related complication (treated or untreated hypertension, dyslipidemia, pre-diabetes)) were randomly assigned. All the patients provided written informed consent before participation. Key exclusion criteria were type 1 or 2 diabetes, the use of medications that cause clinically significant weight gain or loss, previous bariatric surgery, a history of pancreatitis, a history of major depressive or other severe psychiatric disorders, and a family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma. Eligible participants were randomized 2:1 to once-daily subcutaneous injections of either liraglutide or placebo using a computer-generated, centrally administered procedure. Patients, investigators, and the sponsor were unaware of the study-group assignments. The primary endpoint was change in bodyweight during the 28 weeks of the study in the intention-to-treat population. The proportion of people losing more than 5% of baseline weight was also assessed. Secondary efficacy endpoints included the proportion of people losing more than 10% of baseline weight was also assessed, change in waist circumference, hip circumference, WHR, systolic and diastolic blood pressure, fasting lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides), glucose metabolism parameters (fasting plasma glucose, 2-hour post-challenge plasma glucose and glycosylated haemoglobin \[HbA1c\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients were randomly assigned, in a 2:1 ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.6 mg with weekly 0.6-mg increments to 3.0 mg, or placebo; both groups received counseling on lifestyle modification
Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients were randomly assigned, in a 2:1 ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.6 mg with weekly 0.6-mg increments to 3.0 mg, or placebo; both groups received counseling on lifestyle modification
Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGMean Change From Baseline in Fasting Body Weight
mean change from baseline in fasting body weight (%) after 28-weeks of treatment.
Time frame: Week 0, Week 28
Percentage of Subjects Losing at Least 5% of Baseline Fasting Body Weight.
Percentage of subjects losing at least 5% of baseline fasting body weight after 28-weeks of treatment.
Time frame: Week 28
Percentage of Subjects Losing More Than 10% of Baseline Fasting Body Weight.
Percentage of subjects losing \>10% of baseline fasting body weight after 28-weeks of treatment
Time frame: Week 28
Mean Change From Baseline in Waist Circumference (cm)
mean change from baseline in waist circumference (cm) after 28-weeks of treatment
Time frame: Week 0, Week 28
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