Effect of Tesofensine on Energy Balance in Humans.

• ClinicalTrials.gov Identifier: NCT00428415
• Recruitment Status: Completed
• First Posted: January 30, 2007
• Last Update Posted: March 5, 2008
• Sponsor: NeuroSearch A/S
• Information provided by: NeuroSearch A/S

Tracking Information

• First Submitted Date: January 29, 2007
• First Posted Date: January 30, 2007
• Last Update Posted Date: March 5, 2008
• Study Start Date: March 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 29, 2007): Effect on 24-h EE (energy expenditure) after 14 days dosing, adjusted for FFM(Fat-Free Mass) and FM (Fat Mass) changes
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 29, 2007)

• 24-h fat oxidation, spontaneous physical activity, fecal excretion of energy and fat (respiratory chamber),Changes in body weight and composition
• Physical Measure(Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA, Spontaneous energy intake at lunch test
• Metabolic measures (Total triglycerides, Cholesterol-total, LDL-C, HDL-C, LDH, Blood glucose fasting, HbA1c, C-reactive protein, Insulin, Adiponectin, FFA, CCK, Ghrelin, and Leptin)
• Data from questionnaires( Satiety & Appetite, POMS Brief)
• Safety & Tolerability

• 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: Effect of Tesofensine on Energy Balance in Humans.
• Official Title: The Effect of Tesofensine on Energy Balance in Humans. A Randomised, Double-Blind, Placebo-Controlled, Parallel- Group, Single Centre Study.

Brief Summary

Purpose:

To evaluate the effect of tesofensine on energy balance

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Obesity
• Intervention: Drug: Tesofensine
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: January 29, 2007): 32
• Original Enrollment: Same as current
• Actual Study Completion Date: December 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Overweight to obese subjects with BMI 28 - 35 kg/m² otherwise healthy
• Males 18 to 50 years of age, extremes included
• Subjects should be able to comply with study procedures
• Subjects giving written informed consent

Exclusion Criteria:

• Use of any concomitant medication including high dose vitamins and regular OTC preparations
• Subjects who have been smokers within the last year
• Subjects with specific diseases interfering with their metabolism e.g. myxoedema, Cushing's syndrome, Type 1 diabetes mellitus, significant neurological or psychiatric illness such as epilepsy, schizophrenia, depression, eating disorders such as bulimia.
• Subjects 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
• Known hypercholesterolaemia (> 7 mmol/l).
• Known hypertriglyceridaemia (> 3 mmol/l).
• Malabsorptive intestinal disorders that can be assumed to affect the absorption of tesofensine
• Mental or psychiatric disorder based on medical history only
• Subjects with systemic infections or inflammatory diseases
• Subjects currently (within the past 2 months) known to abuse or to be dependent on any drug, including alcohol (weekly consumption > 21 units of alcohol )
• 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)
• Special diets (e.g., vegetarian, Atkins)
• Subject should not be athletics or 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
• Surgically treated obesity
• 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 > 450 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
• Hypertension (i.e. sitting diastolic BP ≥ 95 mm Hg and sitting systolic BP ≥ 155 mm Hg) as well as HR>90 bpm
• Known HIV infection (no tests required)
• Clinically significant or potentially disabling eye disorder, including uncontrolled glaucoma
• Serologic evidence of active hepatitis B and/or C
• History of cancer within the past 5 years, excluding treated basal cell carcinoma
• Subjects previously treated with tesofensine
• Subjects 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: Male

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT00428415
• Other Study ID Numbers: TIPO-2
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: NeuroSearch A/S
• Collaborators: Not Provided

Investigators

• Principal Investigator: Arne V Astrup, MD; Department of Human Nutrition, The Royal Veterinary & Agricultural University

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