Evaluation of Long Term Safety of Tesofensine in Patients With Obesity

• ClinicalTrials.gov Identifier: NCT00481104
• Recruitment Status: Completed
• First Posted: June 1, 2007
• Last Update Posted: July 4, 2011
• Sponsor: NeuroSearch A/S
• Information provided by: NeuroSearch A/S

Tracking Information

• First Submitted Date: May 31, 2007
• First Posted Date: June 1, 2007
• Last Update Posted Date: July 4, 2011
• Study Start Date: May 2007
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 31, 2007): Safety measures: Treatment emergent adverse events, vital signs (BP and HR), ophthalmoscopy, ECG, laboratory assessments and physical examination
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: May 31, 2007): Effect measures: Body weight, waist circumference, waist-hip ratio, BMI, Metabolic measures
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Long Term Safety of Tesofensine in Patients With Obesity
• Official Title: Evaluation of Long Term Safety of Tesofensine in Patients With Obesity
• Brief Summary: Purpose of the study is to evaluate the long term safety of tesofensine in obese patients
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Obesity
• Intervention: Drug: Tesofensine
• Study Arms: Not Provided
• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 1, 2011): 140
• Original Estimated Enrollment (submitted: May 31, 2007): 150
• Actual Study Completion Date: November 2008
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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 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 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
• 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) in females and >450 ms in males, 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)
• 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 treated with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study drug

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT00481104
• Other Study ID Numbers: NS2330-004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: NeuroSearch A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Arne V Astrup, Professor, MD; Faculty of Life Science, University of Copenhagen, Denmark

• PRS Account: NeuroSearch A/S
• Verification Date: March 2008