Effect of Tesofensine on Energy Balance in Humans.

Inclusion Criteria: * Overweight to obese subjects with BMI 28 - 35 kg/m² otherwise healthy * Males 18 to 50 years of age, extremes included * Subjects should be able to comply with study procedures * Subjects giving written informed consent Exclusion Criteria: * Use of any concomitant medication including high dose vitamins and regular OTC preparations * Subjects who have been smokers within the last year * Subjects with specific diseases interfering with their metabolism e.g. myxoedema, Cushing's syndrome, Type 1 diabetes mellitus, significant neurological or psychiatric illness such as epilepsy, schizophrenia, depression, eating disorders such as bulimia. * Subjects with Type 2 diabetes mellitus are ineligible unless anti-diabetic medication was not deemed necessary by the investigator and fasting (venous or arterialized capillary full blood from finger or ear) blood glucose \> 6.1 mmol/l at screening. Re-test is allowed if first measure is above inclusion value. The corresponding exclusion criteria for plasma glucose is 7.0 mmol/l * Known hypercholesterolaemia (\> 7 mmol/l). * Known hypertriglyceridaemia (\> 3 mmol/l). * Malabsorptive intestinal disorders that can be assumed to affect the absorption of tesofensine * Mental or psychiatric disorder based on medical history only * Subjects with systemic infections or inflammatory diseases * Subjects currently (within the past 2 months) known to abuse or to be dependent on any drug, including alcohol (weekly consumption \> 21 units of alcohol ) * Hepatic or renal dysfunction (ASAT and/or ALAT \> 2 x ULN and creatinine clearance \< 30 mL/min estimated by central laboratory using Cockcroft and Gault formula, respectively) * Special diets (e.g., vegetarian, Atkins) * Subject should not be athletics or planning major changes in physical activity during the study to an extent that may interfere with the study outcome, as judged by the investigator * Weight change of \> 3 kg within 2 months prior to screening * Surgically treated obesity * History or presence of significant cardiovascular disease such as heart failure, ischemic heart disease, stroke, transient ischemic attacks * Significant abnormalities on the ECG according to the investigators opinion. Additional exclusionary ECG values: QTcB \> 450 milliseconds(ms), PR interval \> 240 ms, QRS interval \> 120 ms * Hypotension (i.e. supine systolic BP \< 90 mm Hg) and/or symptomatic orthostatic hypotension (clinical symptoms of orthostatic hypotension associated with a decline ≥ 20 mm Hg in systolic BP at one minute after standing compared with the previous supine systolic BP obtained after 5 minutes of quiet rest) at screening visit * Hypertension (i.e. sitting diastolic BP ≥ 95 mm Hg and sitting systolic BP ≥ 155 mm Hg) as well as HR\>90 bpm * Known HIV infection (no tests required) * Clinically significant or potentially disabling eye disorder, including uncontrolled glaucoma * Serologic evidence of active hepatitis B and/or C * History of cancer within the past 5 years, excluding treated basal cell carcinoma * Subjects previously treated with tesofensine * Subjects treated with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study drug