ClinicalTrials.gg
CompletedNCT01035333Updated Apr 4, 2014Results posted

A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.

A Phase 4 interventional study of Orlistat in Obesity, sponsored by Albany College of Pharmacy and Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-04.

Sponsored by Albany College of Pharmacy and Health Sciences · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The primary goal of the study is to determine if orlistat 60mg (Alli) is effective in helping patients achieve a required 10% weight loss goal prior to bariatric surgery. The medication will be added to the usual standard of care which includes education regarding diet and exercise and monthly meetings with a registered dietician.

02

Conditions studied

  • Obesity

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Keywords

  • gastric bypass surgery
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 19 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

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Lead sponsor

Albany College of Pharmacy and Health Sciences is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adult patients preparing for gastric bypass surgery

Exclusion criteria

Exclusion Criteria:

  • pregnancy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    orlistat 60mg

    Patients assigned to treatment group for up to 6 months of therapy.

    Drug: Orlistat

Interventions

  • 60mg capsule three times a day for up to 6 months

    Also known as: Alli

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What researchers measure

Primary outcomes

  1. Weight Loss

    Weight loss acheived during time on study up to 6 months.

    Time frame: 6 months

Secondary outcomes

  1. Patient Satisfaction

    Time frame: 6 months

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Results

Posted Apr 4, 2014
Limitations and caveats
High drop out rate. Patients did not return to clinic and were lost to follow up.

Participant flow

Dates of recruitment 10.14.09 to 12.15.10 Outpatient clinic, Bariatric treatment Center

Participant flow — Overall Study
MilestoneOrlistat 60mg
Started19
Completed9
Not completed10

Outcome measures

PrimaryWeight Loss

Weight loss acheived during time on study up to 6 months.

Time frame:
6 months
Reported as:
Mean · percentage of weight
Weight Loss
percentage of weightOrlistat 60mg
Weight Loss2.0 ± 3.4
SecondaryPatient Satisfaction
Time frame:
6 months
Reported as:
Number · participants
Patient Satisfaction
participantsOrlistat 60mg
Patient Satisfaction9

Adverse events

Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Orlistat 60mg—0/19 (0%)0/19 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Orlistat 60mg
<=18 years0
Between 18 and 65 years19
>=65 years0
Age, Continuous
Age, Continuous(years)Orlistat 60mg
Mean40.9 ± 11.4
Sex: Female, Male
Sex: Female, Male(Participants)Orlistat 60mg
Female14
Male5
Region of Enrollment
Region of Enrollment(participants)Orlistat 60mg
United States19
08

Study locations

1 site
  • Albany College of Pharmacy and Health Sciences
    Albany, New York 12208, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2009, a primary completion of Apr 2011 and a completion of Apr 2011. It does not say whether these dates are actual or estimated.

Results were first posted in Apr 2014, 3 years after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2009
First posted
Dec 18, 2009
Start
Nov 2009
Primary completionActual
Apr 2011
CompletionActual
Apr 2011
Results first posted
Apr 4, 2014
Last update
Apr 4, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01035333
Lead sponsor
Albany College of Pharmacy and Health Sciences
Collaborators
Albany Medical College
Responsible party
Margaret Malone (Dr, Albany College of Pharmacy and Health Sciences) — Principal investigator
First posted
Dec 18, 2009
Start date
Nov 2009
Primary completion
Apr 2011
Completion
Apr 2011
Results posted
Apr 4, 2014
Last update
Apr 4, 2014

Study contacts

Margaret Malone, PhD
principal investigator · Albany College of Pharmacy and Health Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Orlistat

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