Overview

Evaluation of Long Term Safety of Tesofensine in Patients With Obesity

Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
0
Participant gender:
All
Summary
Purpose of the study is to evaluate the long term safety of tesofensine in obese patients
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
NeuroSearch A/S
Criteria
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
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 < 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

- 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 < 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)

- 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 treated with an investigational drug within 30 days or 5 half-lives
(whichever is longer) preceding the first dose of study drug