Effect of Tesofensine on Energy Balance in Humans.

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428415
• Other study ID #: TIPO-2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 29, 2007
• Last updated: March 3, 2008
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: March 2008
• Source: NeuroSearch A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Purpose:

To evaluate the effect of tesofensine on energy balance

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Tesofensine

Locations

Country	Name	City	State
Denmark	NeuroSearch A/S	Ballerup

Sponsors (1)

Lead Sponsor	Collaborator
NeuroSearch A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on 24-h EE (energy expenditure) after 14 days dosing, adjusted for FFM(Fat-Free Mass) and FM (Fat Mass) changes
Secondary	24-h fat oxidation, spontaneous physical activity, fecal excretion of energy and fat (respiratory chamber),Changes in body weight and composition
Secondary	Physical Measure(Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA, Spontaneous energy intake at lunch test
Secondary	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)
Secondary	Data from questionnaires( Satiety & Appetite, POMS Brief)
Secondary	Safety & Tolerability