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ObesityPhase 2NCT00394667

Effect of Tesofensine on Weight Reduction in Patients With Obesity.

A Phase 2 study testing Tesofensine in people with Obesity, run by NeuroSearch A/S at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose: To evaluate the efficacy on weight reduction, metabolic parameters and safety of tesofensine versus placebo in obese patients Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
Tesofensine
How many people
200 participants
Where
1 siteDenmark
Study dates
Sep 2006to Sep 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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))
Show all 31Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • NeuroSearch A/S

    Ballerup Municipality, 2750

Other trials in Denmark

About this study

Official title: Effect of Tesofensine on Weight Reduction in Patients With Obesity. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study.

Purpose:

To evaluate the efficacy on weight reduction, metabolic parameters and safety of tesofensine versus placebo in obese patients

Conditions
Obesity
Being tested
Tesofensine
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TesofensineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change and absolute change in body weight

Secondary outcomes (4)

  1. Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA

  2. blood tests (Triglycerides, Cholesterol-total, LDL-C, HDL-C, LDH, Blood glucose fasting, HbA1c, C-reactive protein, Insulin and Adiponectin )

  3. data from questionnaires (Baecke Questionnaire, Satiety & Appetite Questionnaire, POMS, and Impact of Weight on Quality of Life Questionnaire -Lite Version (IWQOL-Lite))

  4. Safety & Tolerability

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2006 (estimated)
  2. Study startSep 2006
  3. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00394667
Sponsor's protocol ID
TIPO-1
Status last verified
Apr 2013
First submitted
31 Oct 2006
Last updated
22 Apr 2013
Results posted
No

Publications

  • Expression of concern--effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Apr 6;381(9873):1167. doi: 10.1016/S0140-6736(13)60778-3. No abstract available.

    PubMed 23561987

  • Gilbert JA, Gasteyger C, Raben A, Meier DH, Astrup A, Sjodin A. The effect of tesofensine on appetite sensations. Obesity (Silver Spring). 2012 Mar;20(3):553-61. doi: 10.1038/oby.2011.197. Epub 2011 Jun 30.

    PubMed 21720440

  • Astrup A, Madsbad S, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Nov 29;372(9653):1906-1913. doi: 10.1016/S0140-6736(08)61525-1. Epub 2008 Oct 22.

    PubMed 18950853

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tesofensine in people with Obesity, run by NeuroSearch A/S at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change and absolute change in body weight. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00394667, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013.

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