Obesity
Conditions
Brief summary
Purpose: To evaluate the effect of tesofensine on energy balance
Interventions
DRUGTesofensine
Sponsors
NeuroSearch A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect on 24-h EE (energy expenditure) after 14 days dosing, adjusted for FFM(Fat-Free Mass) and FM (Fat Mass) changes | — |
Secondary
| Measure | Time frame |
|---|---|
| Metabolic measures (Total triglycerides, Cholesterol-total, LDL-C, HDL-C, LDH, Blood glucose fasting, HbA1c, C-reactive protein, Insulin, Adiponectin, FFA, CCK, Ghrelin, and Leptin) | — |
| 24-h fat oxidation, spontaneous physical activity, fecal excretion of energy and fat (respiratory chamber),Changes in body weight and composition | — |
| Physical Measure(Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA, Spontaneous energy intake at lunch test | — |
| Data from questionnaires( Satiety & Appetite, POMS Brief) | — |
| Safety & Tolerability | — |
Countries
Denmark
Outcome results
None listed