Effect of liraglutide on body weight in obese subjects without diabetes

INTERVENTION: Product Name: Liraglutide Pharmaceutical Form: Solution for injection INN or Proposed INN: Liraglutide Current Sponsor code: NN2211 Other descriptive name: NNC90‐1170 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.00‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: Xenical Product Name: Xenical Pharmaceutical Form: Capsule* INN or Proposed INN: Xenical Current Sponsor code: A08A B01 Other descriptive name: Orlistat Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 120‐ CONDITION: obesity ; MedDRA version: 9.0 Level: PT Classification code 10012601 PRIMARY OUTCOME: Main Objective: To investigate the efficacy of liraglutide to induce weight loss Primary end point(s): Body weight loss Secondary Objective: •To establish the dose‐response relationship of four dose levels of liraglutide and placebo on weight loss; •To compare the weight lowering effect of liraglutide to orlistat; To investigate the effect induced by liraglutide on:; •Body composition; •Cardiovascular risk factors; •Glucose metabolism incl. ß‐cell function; •Presence of the metabolic syndrome; •Patient reported quality of life; INCLUSION CRITERIA: 1.Informed consent obtained prior to 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 and = 40.0 kg/m2 3.Stable body weight (less than 5% self‐reported change during the previous 3 months) 4.Age between 18 and 65 years (both inclusive) 5.Fasting plasma glucose < 7.0 mmol/L 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) no F.1.3.1 Number of subjects for this age range