Obesity
Conditions
Brief summary
Purpose: To evaluate the efficacy on weight reduction, metabolic parameters and safety of tesofensine versus placebo in obese patients
Interventions
DRUGTesofensine
Sponsors
NeuroSearch A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Obese patients with 30 kg/m² ≤ BMI ≤ 40 kg/m² * Males and females 18 to 65 years of age, extremes included * Patients continuously receiving diet therapy as well as instructions on exercise at least for 2 weeks run-in, who during the run-in before randomization do not gain weight (\< 2 kg) * Females of childbearing potential must be non-pregnant and use safe contraceptive methods (the pill, IUD or surgically sterilized) * Patients should be able to comply with study procedures * Smoking habits should have been stable for at least 2 months * Patients giving written informed consent
Exclusion criteria
* Use of prescription medication as listed * Positive serum pregnancy test for women of childbearing potential * Pregnant or lactating women, or women who are planning to become pregnant within the next 8 months * Patients with specific diseases interfering with their metabolism e.g. untreated myxoedema, Cushing's syndrome, Type 1 diabetes mellitus, significant neurological or psychiatric illness such as epilepsy, schizophrenia, depression, eating disorders such as bulimia. * Patients 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 |
|---|---|
| Percent change and absolute change in body weight | — |
Secondary
| Measure | Time frame |
|---|---|
| Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA | — |
| blood tests (Triglycerides, Cholesterol-total, LDL-C, HDL-C, LDH, Blood glucose fasting, HbA1c, C-reactive protein, Insulin and Adiponectin ) | — |
| data from questionnaires (Baecke Questionnaire, Satiety & Appetite Questionnaire, POMS, and Impact of Weight on Quality of Life Questionnaire -Lite Version (IWQOL-Lite)) | — |
| Safety & Tolerability | — |
Countries
Denmark
Outcome results
None listed