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ObesityPhase 4NCT02706067

Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Adults

A Phase 4 study testing Orlistat in people with Obesity, run by Hoffmann-La Roche at 1 site in Switzerland.

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

This study will evaluate the efficacy of a multifactorial approach associated with orlistat (Xenical) in weight loss maintenance during 4 years. The effect of orlistat in combination with diet, physical activity, and/or cognitive behavioral therapy will be monitored. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
Orlistat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSwitzerland
Study dates
Jul 2002to Mar 2009
Phase
Phase 4
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

  • Body mass index (BMI) greater than or equal to (>/=) 30 kilograms per meter-squared (kg/m^2), or BMI >/= 28 kg/m^2 with risk factors of diabetes, hypertension, or hyperlipidemia, before weight loss
  • Documented weight loss >/= 10% of initial body weight obtained with diet, with or without psychological therapy or orlistat

Who cannot join

  • Pregnant or lactating females
  • History or presence of significant medical disorders
  • Active gastrointestinal disorders such as peptic ulcer disease or malabsorption syndromes
  • Pancreatic disease: pancreatic enzyme deficiency, history or current presence of pancreatitis
  • Clinically significant abnormal clinical chemistry or hematology results
  • Excessive alcohol intake
Show all 10Show fewer
  • Smoking cessation within the previous 6 months
  • History or presence of cancer
  • Administration of medicines known to alter body weight
  • History or presence of cancer

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Study site

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Patients

This study will evaluate the efficacy of a multifactorial approach associated with orlistat (Xenical) in weight loss maintenance during 4 years. The effect of orlistat in combination with diet, physical activity, and/or cognitive behavioral therapy will be monitored.

Conditions
Obesity
Being tested
Orlistat
Medical subject headings
Obesity

What participants receive

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

  • OrlistatDrug

    Also called Xenical

    Participants will receive orlistat on an intermittent basis as 120 milligrams (mg) three times a day: once with breakfast, once with lunch, and once with dinner. In case of weight relapse (increase 2.5 percent [%] or more from Baseline) orlistat will be administered for up to 2 months or until weight regain reaches 0% from Baseline. For special occasions (feasts, birthdays, anniversaries) orlistat will be given for up to 3 days.

Study groups in NCT02706067
Study groupRoleWhat they receive
OrlistatExperimentalParticipants will receive intermittent orlistat for up to 4 years, with the dose determined according to body weight changes.
Receives: Drug: Orlistat

What is being measured

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

  1. Percent Change from Baseline in Body Weight at Year 2

    Measured: Baseline and Year 2

  2. Percent Change from Baseline in Body Weight at Year 4

    Measured: Baseline and Year 4

Secondary outcomes (10)

  1. Percentage of Participants Diagnosed with Binge Eating Disorder According to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Criteria

    Measured: Every 6 months during Year 1, annually during Years 2 to 4

  2. Eating Disorder Inventory (EDI) 2 Subscale and Total Score

    Measured: Baseline and Year 4

  3. Hospital Anxiety and Depression (HAD) Subscale Score

    Measured: Baseline and Year 4

  4. Number of Orlistat Capsules Taken During the Study

    Measured: Given up to three times per day for 4 years

  5. Duration of Orlistat Treatment During the Study

    Measured: Given up to three times per day for 4 years

  6. Waist-to-Hip Circumference Ratio

    Measured: Baseline and Year 4

  7. Waist, Hip, Wrist, and Arm Circumference (Expressed in Centimeters)

    Measured: Baseline and Year 4

  8. Skinfold Thickness (Expressed in Millimeters)

    Measured: Baseline and Year 4

  9. Bioelectrical Impedance (Expressed in Kilograms of Body Fat Mass)

    Measured: Baseline and Year 4

  10. Number of Kilocalories Expended, Total and at Rest

    Measured: Baseline and Year 4

Timeline

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

  1. First posted11 Mar 2016 (estimated)
  2. Study startJul 2002
  3. Primary completionMar 2009
  4. Study completionMar 2009

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02706067
Sponsor's protocol ID
ML16868
Status last verified
Apr 2016
First submitted
8 Mar 2016
Last updated
5 Apr 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Orlistat in people with Obesity, run by Hoffmann-La Roche at 1 site in Switzerland.

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 2 inclusion and 10 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 5 Apr 2016. 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 Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 from Baseline in Body Weight at Year 2 (time frame: Baseline and Year 2). The study lists 2 primary outcomes in all. 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 NCT02706067.

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 5 Apr 2016.

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