Tesofensine in Obesity - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Obesity

Intervention / Treatment

Drug: Tesofensine

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

Phase 2

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

Denmark
- - Ballerup, Denmark, 2750
    - NeuroSearch A/S

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Obese patients with 30 kg/m² ≤ BMI ≤ 40 kg/m²
Males and females 18 to 65 years of age, extremes included
Patients continuously receiving diet therapy as well as instructions on exercise at least for 2 weeks run-in, who during the run-in before randomization do not gain weight (< 2 kg)
Females of childbearing potential must be non-pregnant and use safe contraceptive methods (the pill, IUD or surgically sterilized)
Patients should be able to comply with study procedures
Smoking habits should have been stable for at least 2 months
Patients giving written informed consent

Exclusion Criteria:

Use of prescription medication as listed
Positive serum pregnancy test for women of childbearing potential
Pregnant or lactating women, or women who are planning to become pregnant within the next 8 months
Patients with specific diseases interfering with their metabolism e.g. untreated myxoedema, Cushing's syndrome, Type 1 diabetes mellitus, significant neurological or psychiatric illness such as epilepsy, schizophrenia, depression, eating disorders such as bulimia.
Patients 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
Patients currently (within the past 2 months) known to abuse or to be dependent on any drug, including alcohol (weekly consumption > 21 units of alcohol (men) or >14 units of alcohol (women))
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)
Known untreated hypercholesterolaemia (> 7 mmol/l). Patients with well regulated cholesterol using drugs for hypercholesterolaemia are allowed inclusion
Known untreated hypertriglyceridaemia (> 3 mmol/l). Patients with well regulated triglyceride levels using drugs for hypertriglyceridaemia are allowed inclusion
Drug treated thyroid diseases (well substituted hypothyroidism is allowed)
Patients who suffer from hyperthyroid disease are not allowed in the study, even though they may be well treated by drugs
Patients, who have recently diagnosed, not yet stable hypothyroid disease are not allowed in the study
Patients who suffer from longstanding stable hypothyroid disease, well treated substitution are allowed to be included including hypothyroidism as a sequelae to definitive treatment of hyperthyroidism by surgery or radioactive iodine
Malabsorptive intestinal disorders that can be assumed to affect the absorption of tesofensine
Special diets (e.g., vegetarian, Atkins)
Patients 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
Mental or psychiatric disorder based on medical history only
Surgically treated obesity
Patients with systemic infections or inflammatory diseases
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 > 480 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
Uncontrolled hypertension (i.e. sitting diastolic BP ≥ 95 mm Hg and sitting systolic BP ≥ 155 mm Hg) despite treatment for > 4 weeks prior to the screening visit as well as HR>90 bpm
Known HIV infection (no tests required)
Serologic evidence of active hepatitis B and/or C
History of cancer within the past 5 years, excluding treated basal cell carcinoma
Clinically significant or potentially disabling eye disorder, including uncontrolled glaucoma
Current treatment with medication with known ocular toxicity such as chloroquine and hydroxychloroquine is prohibited
Patients previously treated with tesofensine
Patients 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
Percent change and absolute change in body weight

Secondary Outcome Measures

Outcome Measure
Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA
blood tests (Triglycerides, Cholesterol-total, LDL-C, HDL-C, LDH, Blood glucose fasting, HbA1c, C-reactive protein, Insulin and Adiponectin )
data from questionnaires (Baecke Questionnaire, Satiety & Appetite Questionnaire, POMS, and Impact of Weight on Quality of Life Questionnaire -Lite Version (IWQOL-Lite))
Safety & Tolerability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroSearch A/S

Investigators

Principal Investigator: Arne V Astrup, MD, Department of Human Nutrition, The Royal Veterinary & Agricultural University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2006

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

October 31, 2006

First Submitted That Met QC Criteria