ObesityPhase 3NCT01755676
Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults
A Phase 3 study testing Orlistat 60 mg in people with Obesity, run by EMS at 5 sites in Brazil.
Trial summary
The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of Obesity in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Orlistat 60 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 638 participants
- Where
- 5 sitesBrazil
- Study dates
- Sep 2016to 21 Dec 2017
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent;
- Adults Male and Female ≥ 18 years old;
- Obesity (BMI ≥ 30kg/m2 or ≥ 27 Kg/m2 with associate risk);
Who cannot join
- Pregnancy and Lactation or women without effective contraception;
- Relevant clinical diseases;
- Obesity associated to genetic syndrome;
- Decompensated Diabetes;
- Psychiatric disorders;
- Alimentary disorders;
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- Use of: anorectics, herbal weight loss and/or constipation and laxatives, in the past 30 days;
- Patients using cyclosporine or amiodarone;
- Patients with bowel disease;
- Prior bariatric surgery;
- Anemia;
- Hemoglobinopathies and coagulopathy;
- History of cancer in the past five years;
- Use of corticosteroids, oral or injectable, in the last 30 days.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Loema
Campinas, São Paulo, 13010001
Allergisa
Campinas, São Paulo
CIPMED
Jaú, São Paulo
Centro de Medicina Reprodutiva Dr Carlos Isaia Filho
Porto Alegre, Rio Grande do Sul
Marcio Antonio Pereira Clinica de Endocrinologia
São José dos Campos, São Paulo
About this study
Official title: A Prospective Study, Parallel, Double-blind, Multicenter for Evaluation of Efficacy of Orlistat 60 mg as Adjuvant Treatment of Obesity in Adults
The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of Obesity in adults.
- Conditions
- Obesity
- Being tested
- Orlistat 60 mg, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orlistat 60 mgDrug
1 tablet 3 times a day
PlaceboOther
1 tablet 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Orlistat 60 mg | Experimental | Not described Receives: Drug: Orlistat 60 mg |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Orlistat 60 mg associated with diet and exercise in relation to placebo associated with diet and exercise in obesity treatment based on weight loss.
Measured: 112 days
Secondary outcomes (1)
Safety will be evaluated by the adverse events occurrences
Measured: 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startSep 2016
- Primary completionDec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 638 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755676
- Sponsor's protocol ID
- ORL60EMS0511
- Status last verified
- Apr 2020
- First submitted
- 17 Dec 2012
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study, Parallel, Double-blind, Multicenter for Evaluation of Efficacy of Orlistat 60 mg as Adjuvant Treatment of Obesity in Adults
- ClinicalTrials.gov ID
- NCT01755676
- Acronym / sponsor ID
- ORL60EMS0511
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 638 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of Obesity in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orlistat 60 mg | Experimental | Drug: Orlistat 60 mg |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed Consent;
- Adults Male and Female ≥ 18 years old;
- Obesity (BMI ≥ 30kg/m2 or ≥ 27 Kg/m2 with associate risk);
Key exclusion criteria (14 listed)
- Pregnancy and Lactation or women without effective contraception;
- Relevant clinical diseases;
- Obesity associated to genetic syndrome;
- Decompensated Diabetes;
- Psychiatric disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orlistat 60 mg1 tablet 3 times a day | Drug | Orlistat 60 mg |
| Placebo1 tablet 3 times a day | Other | Placebo |
Primary outcome
Efficacy of Orlistat 60 mg associated with diet and exercise in relation to placebo associated with diet and exercise in obesity treatment based on weight loss.
Time frame: 112 days
1 secondary outcome
Safety will be evaluated by the adverse events occurrences
Time frame: 112 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Orlistat 60 mg in people with Obesity, run by EMS at 5 sites in Brazil.
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 3 inclusion and 14 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 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy of Orlistat 60 mg associated with diet and exercise in relation to placebo associated with diet and exercise in obesity treatment based on weight loss. (time frame: 112 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2020.