AzTrials
AzTrials

ObesityPhase 2NCT00481104

Evaluation of Long Term Safety of Tesofensine 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
Search all trials

Trial summary

Purpose of the study is to evaluate the long term safety of tesofensine 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
140 participants
Where
1 siteDenmark
Study dates
May 2007to Nov 2008
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

  • Patients who have completed their participation in TIPO-1
  • Males and females 18 to 65,5 years of age, extremes included
  • Patients continuously receiving diet therapy as well as instructions on exercise
  • Females of childbearing potential must be non-pregnant and use safe contraceptive methods (the pill, IUD, injection of prolonged gestagen, sub dermal implantation, hormonal vaginal devices, transdermal patches or surgically sterilized)
  • Patients should be able to comply with study procedures
  • Patients giving written informed consent

Who cannot join

  • Patients with a BMI< 22
  • Use of prescription medication as listed in Appendix 1
  • Positive pregnancy test for women of childbearing potential
  • Pregnant 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
Show all 29Show fewer
  • Patients 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
  • 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) in females and >450 ms in males, 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)
  • 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 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

  • Faculty of Life Sciences, University of Copenhagen

    Copenhagen, Frederiksberg, 1958

Other trials in Denmark

About this study

Purpose of the study is to evaluate the long term safety of tesofensine in obese patients

Conditions
Obesity
Being tested
Tesofensine
Keywords
Obesity
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. Safety measures: Treatment emergent adverse events, vital signs (BP and HR), ophthalmoscopy, ECG, laboratory assessments and physical examination

Secondary outcomes (1)

  1. Effect measures: Body weight, waist circumference, waist-hip ratio, BMI, Metabolic measures

Timeline

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

  1. First posted1 Jun 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionSep 2008
  4. Study completionNov 2008

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00481104
Sponsor's protocol ID
NS2330-004
Status last verified
Mar 2008
First submitted
31 May 2007
Last updated
4 Jul 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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

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 6 inclusion and 29 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 4 Jul 2011. 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?

Safety measures: Treatment emergent adverse events, vital signs (BP and HR), ophthalmoscopy, ECG, laboratory assessments and physical examination. 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 NCT00481104, which also lists 1 linked publication.

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 4 Jul 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in