Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE - Obesity and Pre-diabetes
- Conditions
- Health Condition 1: null- ObesityHealth Condition 2: E65-E68- Overweight, obesity and other hyperalimentationHealth Condition 3: E65-E68- Overweight, obesity and other hyperalimentation
- Registration Number
- CTRI/2011/12/002199
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 86
Informed consent obtained
Body Mass Index (BMI) of 30.0 kg/m2 or above
Body Mass Index (BMI) of 27 kg/m2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension
Stable body weight
Preceding failed dietary effort
Note-this trial has no upper age limit
Known type 1 or type 2 diabetes
Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126 mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2)
Screening calcitonin of 50 ng/L or above
Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
Personal history of non-familial medullary thyroid carcinoma
History of acute or chronic pancreatitis
Obesity induced by drug treatment
Use of approved weight lowering pharmacotherapy
Previous surgical treatment of obesity
History of major depressive disorder or suicide attempt
Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in body weight (fasting)Timepoint: 56 weeks;Change from baseline in body weight (fasting)Timepoint: 56 weeks;Change from baseline in body weight (fasting)Timepoint: 56 weeks;Change from baseline in body weight (fasting)Timepoint: 56 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in body weight (fasting) (re-randomised subjects with no pre-diabetes)Timepoint: 56 week and 68 week;Change from baseline in pre-diabetes statusTimepoint: 56 weeks;Change from baseline in pre-diabetes status (subjects with pre-diabetes at baseline)Timepoint: 160 week;Change from baseline in waist circumferenceTimepoint: 56 week;Change from baseline in waist circumference (subjects with pre-diabetes at baseline)Timepoint: 160 week;Mean change from baseline in body weight (subjects with pre-diabetes at baseline)Timepoint: 160 week;Proportion of subjects losing at least 5% and more than 10% of baseline body weight (subjects with pre-diabetes at baseline)Timepoint: 160 week