Obesity MedDRA version: 8.1 Level: LLT Classification code 10029883 Term: Obesity
Conditions
Interventions
Product Name: Tesofensine
Product Code: NS2330
Pharmaceutical Form: Tablet
Current Sponsor code: NS2330
Other descriptive name: Tesofensine
Concentration unit: mg milligram(s)
Concentration type: rang
Sponsors
NeuroSearch A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females 18 to 65 years of age, extremes included 2. Patients continuously receiving diet therapy as well as instructions on exercise at least for 2 weeks run-in, who during the run-in before randomisation do not gain weight ( =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Use of prescription medication 2. Positive serum pregnancy test for women of childbearing potential 3. Pregnant or lactating women, or women who are planning to become pregnant within the next 18 months 4. 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. 5. 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 exclusion criteria for plasma glucose is 7.0 mmol/l. 6. Patients currently (within the past 2 months) known to abuse or to be dependent on any drug, including alcohol (weekly consumption > 21 units of alcohol (men) or >14 units of alcohol (women)) 7. Hepatic or renal dysfunction (ASAT and/or ALAT > 2 x ULN and creatinine clearance 7 mmol/l). Patients with well regulated cholesterol using drugs for hypercholesterolaemia are allowed inclusion. 9. Known untreated hypertriglyceridaemia (> 3 mmol/l). Patients with well regulated triglyceride levels using drugs for hypertriglyceridaemia are allowed inclusion. 10. Drug treated thyroid diseases (well substituted long standing hypothyroidism is allowed, including hypothyroidism as a sequelae to definitive treatment of hyperthyroidism by surgery or radioactive iodine) 11. Special diets (e.g., vegetarian, Atkins) 12. Malabsorptive intestinal disorders that can be assumed to affect the absorption of tesofensine 13. Patients planning major changes in physical activity during the study to an extent that may interfere with the study outcome, as judged by the investigator 14. Surgically treated obesity 15. Weight change of > 3 kg within 2 months prior to screening 16. Mental disorders or psychiatric disorder based on medical history only 17. Patients with systemic infections or inflammatory diseases 18. History or presence of significant cardiovascular disease such as heart failure, ischemic heart disease, stroke, transient ischemic attacks 19. Significant abnormalities on the ECG according to the investigators opinion. Additional exclusionary ECG values: QTcB > 480 milliseconds (ms), PR interval > 240 ms, QRS interval > 120 ms 20. Hypotension (i.e. supine systolic BP 4 weeks prior to the screening visit as well as HR>90 bpm. 22. Known HIV infection (no tests required) 23. Serologic evidence of active hepatitis B and/or C 24. History of cancer within the past 5 years, excluding treated basal cell carcinoma 25. Clinically significant or potentially disabling eye disorder, including uncontrolled glaucoma 26. Current treatment with medication with known ocular toxicity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy on weight reduction, metabolic parameters and safety of tesofensine versus placebo in obese patients.;Secondary Objective: ;Primary end point(s): Absolut change and percent change in body weight from baseline to end of treatment at week 24. | — |
Countries
Denmark
Outcome results
None listed