Effect of Tesofensine on Energy Balance in Humans.

This study has been completed.
Sponsor:
Information provided by:
NeuroSearch A/S
ClinicalTrials.gov Identifier:
NCT00428415
First received: January 29, 2007
Last updated: March 3, 2008
Last verified: March 2008
  Purpose

Purpose:

To evaluate the effect of tesofensine on energy balance


Condition Intervention Phase
Obesity
Drug: Tesofensine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Tesofensine on Energy Balance in Humans. A Randomised, Double-Blind, Placebo-Controlled, Parallel- Group, Single Centre Study.

Resource links provided by NLM:


Further study details as provided by NeuroSearch A/S:

Primary Outcome Measures:
  • Effect on 24-h EE (energy expenditure) after 14 days dosing, adjusted for FFM(Fat-Free Mass) and FM (Fat Mass) changes

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 32
Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428415

Locations
Denmark
NeuroSearch A/S
Ballerup, Denmark, 2750
Sponsors and Collaborators
NeuroSearch A/S
Investigators
Principal Investigator: Arne V Astrup, MD Department of Human Nutrition, The Royal Veterinary & Agricultural University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00428415     History of Changes
Other Study ID Numbers: TIPO-2
Study First Received: January 29, 2007
Last Updated: March 3, 2008
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014