- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00428415
Effect of Tesofensine on Energy Balance in Humans.
March 3, 2008 updated by: NeuroSearch A/S
The Effect of Tesofensine on Energy Balance in Humans. A Randomised, Double-Blind, Placebo-Controlled, Parallel- Group, Single Centre Study.
Purpose:
To evaluate the effect of tesofensine on energy balance
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
32
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ballerup, Denmark, 2750
- NeuroSearch A/S
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Effect on 24-h EE (energy expenditure) after 14 days dosing, adjusted for FFM(Fat-Free Mass) and FM (Fat Mass) changes
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Secondary Outcome Measures
Outcome Measure |
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Safety & Tolerability
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24-h fat oxidation, spontaneous physical activity, fecal excretion of energy and fat (respiratory chamber),Changes in body weight and composition
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Physical Measure(Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA, Spontaneous energy intake at lunch test
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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)
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Data from questionnaires( Satiety & Appetite, POMS Brief)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Arne V Astrup, MD, Department of Human Nutrition, The Royal Veterinary & Agricultural University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
January 29, 2007
First Submitted That Met QC Criteria
January 29, 2007
First Posted (Estimate)
January 30, 2007
Study Record Updates
Last Update Posted (Estimate)
March 5, 2008
Last Update Submitted That Met QC Criteria
March 3, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- TIPO-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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