Obesity
Conditions
Keywords
Obesity
Brief summary
Purpose of the study is to evaluate the long term safety of tesofensine in obese patients
Interventions
DRUGTesofensine
Sponsors
NeuroSearch A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients who have completed their participation in TIPO-1 * Males and females 18 to 65,5 years of age, extremes included * Patients continuously receiving diet therapy as well as instructions on exercise * Females of childbearing potential must be non-pregnant and use safe contraceptive methods (the pill, IUD, injection of prolonged gestagen, sub dermal implantation, hormonal vaginal devices, transdermal patches or surgically sterilized) * Patients should be able to comply with study procedures * Patients giving written informed consent
Exclusion criteria
* Patients with a BMI\< 22 * Use of prescription medication as listed in Appendix 1 * Positive pregnancy test for women of childbearing potential * Pregnant 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 |
|---|---|
| Safety measures: Treatment emergent adverse events, vital signs (BP and HR), ophthalmoscopy, ECG, laboratory assessments and physical examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect measures: Body weight, waist circumference, waist-hip ratio, BMI, Metabolic measures | — |
Countries
Denmark
Outcome results
None listed