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 randomisatio

Active, not recruiting

• Conditions: Obesity and overweight; MedDRA version: 9.1Level: LLTClassification code 10029883Term: Obesity; MedDRA version: 9.1Level: LLTClassification code 10033307Term: Overweight

• Registration Number: EUCTR2008-001049-24-FR
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-13
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 4800

Inclusion Criteria

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/m^2 or = 27 kg/m^2 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

Exclusion Criteria

Key exclusion criteria:
• Known type 1 or type 2 diabetes
• HbA_1c = 7 % or FPG = 7 mmol/L
• 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 = 160 mmHg and/or diastolic blood pressure = 100 mmHg)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified