Effect of Tesofensine on Weight Reduction in Patients With Obesity.

Obesity Clinical Trial

Official title:

Effect of Tesofensine on Weight Reduction in Patients With Obesity. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394667
• Other study ID #: TIPO-1
• Status: Completed
• Phase: Phase 2
• First received: October 31, 2006
• Last updated: April 19, 2013
• Start date: September 2006
• Est. completion date: September 2007

Study information

• Verified date: April 2013
• Source: NeuroSearch A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

Purpose:

To evaluate the efficacy on weight reduction, metabolic parameters and safety of tesofensine versus placebo in obese patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Drug:
• Tesofensine

Locations

Country	Name	City	State
Denmark	NeuroSearch A/S	Ballerup

Sponsors (1)

Lead Sponsor	Collaborator
NeuroSearch A/S

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Expression of concern--effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Apr 6;381(9873):1167. doi: 10.1016/S0140-6736(13)60778-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change and absolute change in body weight
Secondary	Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA
Secondary	blood tests (Triglycerides, Cholesterol-total, LDL-C, HDL-C, LDH, Blood glucose fasting, HbA1c, C-reactive protein, Insulin and Adiponectin )
Secondary	data from questionnaires (Baecke Questionnaire, Satiety & Appetite Questionnaire, POMS, and Impact of Weight on Quality of Life Questionnaire -Lite Version (IWQOL-Lite))
Secondary	Safety & Tolerability