Effect of Tesofensine on Weight Reduction in Patients With Obesity.

This study has been completed.
Sponsor:
Information provided by:
NeuroSearch A/S
ClinicalTrials.gov Identifier:
NCT00394667
First received: October 31, 2006
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

Purpose:

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


Condition Intervention Phase
Obesity
Drug: Tesofensine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Tesofensine on Weight Reduction in Patients With Obesity. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study.

Resource links provided by NLM:


Further study details as provided by NeuroSearch A/S:

Primary Outcome Measures:
  • Percent change and absolute change in body weight

Secondary Outcome Measures:
  • Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA
  • blood tests (Triglycerides, Cholesterol-total, LDL-C, HDL-C, LDH, Blood glucose fasting, HbA1c, C-reactive protein, Insulin and Adiponectin )
  • data from questionnaires (Baecke Questionnaire, Satiety & Appetite Questionnaire, POMS, and Impact of Weight on Quality of Life Questionnaire -Lite Version (IWQOL-Lite))
  • Safety & Tolerability

Estimated Enrollment: 200
Study Start Date: September 2006
Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394667

Locations
Denmark
NeuroSearch A/S
Ballerup, Denmark, 2750
Sponsors and Collaborators
NeuroSearch A/S
Investigators
Principal Investigator: Arne V Astrup, MD Department of Human Nutrition, The Royal Veterinary & Agricultural University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00394667     History of Changes
Other Study ID Numbers: TIPO-1
Study First Received: October 31, 2006
Last Updated: April 19, 2013
Health Authority: Denmark: National Board of Health

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 23, 2014