Effect of Tesofensine on Weight Reduction in Patients With Obesity.

NCT00394667 | Completed Phase 2

• 1 other identifier: TIPO-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Percent change and absolute change in body weight

Secondary Outcomes (4)

• 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

Interventions

Tesofensine DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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)
• 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

Sponsors & Collaborators

• NeuroSearch A/S: lead

Study Sites (1)

NeuroSearch A/S

Ballerup Municipality, 2750, Denmark

Location

Related Publications (3)

• 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. No abstract available.

  PMID: 23561987 BACKGROUND

• Gilbert JA, Gasteyger C, Raben A, Meier DH, Astrup A, Sjodin A. The effect of tesofensine on appetite sensations. Obesity (Silver Spring). 2012 Mar;20(3):553-61. doi: 10.1038/oby.2011.197. Epub 2011 Jun 30.

  PMID: 21720440 DERIVED

• Astrup A, Madsbad S, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Nov 29;372(9653):1906-1913. doi: 10.1016/S0140-6736(08)61525-1. Epub 2008 Oct 22.

  PMID: 18950853 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Tesofensine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arne V Astrup, MD

  Department of Human Nutrition, The Royal Veterinary & Agricultural University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 31, 2006
• First Posted: November 1, 2006
• Study Start: September 1, 2006
• Study Completion: September 1, 2007
• Last Updated: April 22, 2013

Record last verified: 2013-04

Locations

DK (1)