Clinical trial NCT00428415 (phase 1/phase 2, status: completed)
Conditions: obesity
ICD codes: E66.8, E66.9, E66.1, O99.214, O99.215, O99.210, O99.211
Drugs: tesofensine
SMILES: CCOC[C@H]1[C@H]2CC[C@@H](C[C@@H]1C1=CC(Cl)=C(Cl)C=C1)N2C
Eligibility criteria:

        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