Effect of Tesofensine on Energy Balance in Humans.

NCT00428415 | Completed Phase 1

• 1 other identifier: TIPO-2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To evaluate the effect of tesofensine on energy balance

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• 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

Interventions

Tesofensine DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• NeuroSearch A/S: lead

Study Sites (1)

NeuroSearch A/S

Ballerup Municipality, 2750, Denmark

Location

MeSH Terms

Conditions

Obesity

Interventions

Tesofensine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arne V Astrup, MD

  Department of Human Nutrition, The Royal Veterinary & Agricultural University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 30, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 5, 2008

Record last verified: 2008-03

Locations

DK (1)