Effect of liraglutide on body weight in non-diabetic obese subjects or overweight subjects with comorbidities A randomised, double-blind, placebo controlled, parallel group, multi-centre, multinational trial with stratification of subject to either 56 or 160 weeks of treatment based on pre-diabetes status at randomisation - SCALE™ – Obesity and Pre-diabetes

• Conditions: Obesity and overweightPre-diabetes; MedDRA version: 14.1Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-04
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3600

Inclusion Criteria

• Informed consent obtained
• Body Mass Index (BMI) = 30.0 kg/m2 or = 27 kg/m2 in the presence of co-morbidities (treated or untreated hypertension or dyslipidaemia)
• Stable body weight
• Preceding failed dietary effort
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

• Known type 1 or type 2 diabetes
• HbA1c = 6.5 % (Screening visit 1) or FPG = 126 mg/dL (7 mmol/L) (Screening visit 2) or 2 hr post-challenge (OGTT) plasma glucose =200 mg/dL (11.1 mmol/L) (Screening visit 2)
• Screening calcitonin = 50 ng/L
• 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

Study & Design

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