Evaluation of Long Term Safety of Tesofensine in Patients With Obesity

NCT00481104 | Completed Phase 2

• 1 other identifier: NS2330-004
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of the study is to evaluate the long term safety of tesofensine in obese patients

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• Safety measures: Treatment emergent adverse events, vital signs (BP and HR), ophthalmoscopy, ECG, laboratory assessments and physical examination

Secondary Outcomes (1)

• Effect measures: Body weight, waist circumference, waist-hip ratio, BMI, Metabolic measures

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:

• 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

You may not qualify if:

• 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 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
• Mental or psychiatric disorder based on medical history only

Sponsors & Collaborators

• NeuroSearch A/S: lead

Study Sites (1)

Faculty of Life Sciences, University of Copenhagen

Copenhagen, Frederiksberg, 1958, Denmark

Location

Related Publications (1)

• 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

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, Professor, MD

  Faculty of Life Science, University of Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 31, 2007
• First Posted: June 1, 2007
• Study Start: May 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 4, 2011

Record last verified: 2008-03

Locations

DK (1)