Status:
COMPLETED
Effect of Tesofensine on Weight Reduction in Patients With Obesity.
Lead Sponsor:
NeuroSearch A/S
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Purpose: To evaluate the efficacy on weight reduction, metabolic parameters and safety of tesofensine versus placebo in obese patients
Eligibility Criteria
Inclusion
- 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
- 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 exclusion criteria for plasma glucose is 7.0 mmol/l
- 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))
- Hepatic or renal dysfunction (ASAT and/or ALAT \> 2 x ULN and creatinine clearance \< 30 mL/min estimated by central laboratory using Cockcroft and Gault formula, respectively)
- Known untreated hypercholesterolaemia (\> 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
- Weight change of \> 3 kg within 2 months prior to screening
- 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), PR interval \> 240 ms, QRS interval \> 120 ms
- Hypotension (i.e. supine systolic BP \< 90 mm Hg) and/or symptomatic orthostatic hypotension (clinical symptoms of orthostatic hypotension associated with a decline ≥ 20 mm Hg in systolic BP at one minute after standing compared with the previous supine systolic BP obtained after 5 minutes of quiet rest) at screening visit
- Uncontrolled hypertension (i.e. sitting diastolic BP ≥ 95 mm Hg and sitting systolic BP ≥ 155 mm Hg) despite treatment for \> 4 weeks prior to the screening visit as well as HR\>90 bpm
- Known HIV infection (no tests required)
- Serologic evidence of active hepatitis B and/or C
- History of cancer within the past 5 years, excluding treated basal cell carcinoma
- Clinically significant or potentially disabling eye disorder, including uncontrolled glaucoma
- Current treatment with medication with known ocular toxicity such as chloroquine and hydroxychloroquine is prohibited
- Patients previously treated with tesofensine
- Patients treated with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study drug
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00394667
Start Date
September 1 2006
End Date
September 1 2007
Last Update
April 22 2013
Active Locations (1)
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1
NeuroSearch A/S
Ballerup Municipality, Denmark, 2750