Effect of liraglutide on body weight in non-diabetic obese subjects or overweight subjects with co-morbiditiesA randomised, double-blind, placebo controlled, parallel group, multi-centre, multinational trial with stratification of subject to either one or three years of treatment based on pre-diabetes status at randomisation - eliot
- Conditions
- non-diabetic obese subjects or overweight subjects with co-morbiditiesMedDRA version: 9.1Level: SOCClassification code 10027433Term: Metabolism and nutrition disorders
- Registration Number
- EUCTR2008-001049-24-IT
- Lead Sponsor
- OVO NORDISK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 4800
1.Informed consent obtained before any trial-related activities (Trial related activities are any procedure that would not have been performed during the normal management of the subject)
2.Body Mass Index (BMI) 30.0 kg/m2 or 27 kg/m2 in the presence of co-morbidities (treated or untreated hypertension or dyslipidaemia according to ATP-III)
3.Stable body weight (less than 5 kg self-reported change during the previous 3 months)
4.Preceding failed dietary effort
5.Age ≥ 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Diagnosis of type 1 or type 2 diabetes per the judgement of the Investigator
HbA1c ≥ 7 % at Visit 1
History of chronic pancreatitis or idiopathic acute pancreatitis
Obesity induced by drug treatment
Use of approved weight lowering pharmacotherapy
Previous surgical treatment of obesity
History of major depressive desorder or suicide attempt
Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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