Obesity MedDRA version: 9.1 Level: LLT Classification code 10029883 Term: Obesity
Conditions
Interventions
Product Name: Tesofensine
Product Code: NS2330
Pharmaceutical Form: Tablet
Sponsors
NeuroSearch A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients with a BMI 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 •Patients 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)) •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 •Known untreated hypertriglyceridaemia (> 3 mmol/l). Patients with well regulated triglyceride levels using drugs for hypertriglyceridaemia are allowed inclusion •Drug treated thyroid diseases (well substituted hypothyroidism is allowed) •Patients who suffer from hyperthyroid disease are not allowed in the study, even though they may be well treated by drugs •Patients, who have recently diagnosed, not yet stable hypothyroid disease are not allowed in the study •Patients who suffer from longstanding stable hypothyroid disease, well treated substitution are allowed to be included including hypothyroidism as a sequelae to definitive treatment of hyperthyroidism by surgery or radioactive iodine •Malabsorptive intestinal disorders that can be assumed to affect the absorption of tesofensine •Special diets (e.g., vegetarian, Atkins) •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 •Mental or psychiatric disorder based on medical history only •Surgically treated obesity •Patients with systemic infections or inflammatory diseases •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 > 480 milliseconds (ms) in females and >450 ms in males, PR interval > 240 ms, QRS interval > 120 ms •Hypotension (i.e. supine systolic BP 4 weeks prior to the screening visit as well as HR>90 bpm •Known HIV infection (no tests required) •History of cancer within the past 5 years, excluding treated basal cell carc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of long term safety of tesofensine in obese patients;Secondary Objective: Evaluation of effect of tesofensine on wieght reduction in obese patients;Primary end point(s): Treatment emergent adverse events, vital signs (BP and HR), body temperature, ophthalmoscopy, ECG, laboratory assessments and physical examination | — |
Countries
Denmark
Outcome results
None listed