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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014