Effect of Tesofensine on Energy Balance in Humans.

NeuroSearch A/S

Status and phase

Completed

Phase 2

Phase 1

Conditions

Obesity

Treatments

Drug: Tesofensine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00428415

TIPO-2

Details and patient eligibility

About

Purpose:

To evaluate the effect of tesofensine on energy balance

Enrollment

32 estimated patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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