Effect of tesofensine on weight reduction in patients with obesity. A randomised, double-blind, placebo-controlled, parallel-group, multi-centre study. - TIPO-1

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 ( < 2 kg)
3. Females of childbearing potential must be non-pregnant and use safe contraceptive methods ( the pill, IUD or surgically sterilized)
4. Patients should be able to comply with study procedures
5. Smoking habits should have been stable for at least 2 months
6. 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) no
F.1.3.1 Number of subjects for this age range

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 < 30 mL/min estimated by central laboratory using Cockcroft and Gault formula, respectively)
8. Known untreated hypercholesterolaemia (> 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 < 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
21. 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.
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials