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ObesityPhase 4NCT00752726

Effect of Orlistat in Body Composition

A Phase 4 study testing Orlistat in people with Obesity and Overweight, run by GlaxoSmithKline at 3 sites in 2 countries.

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

The purpose of this study is to determine if a 24 week weight loss program with orlistat 60 mg will produce greater changes in body composition compared to placebo. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Overweight
What is being tested?
Orlistat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
131 participants
Where
3 sitesin 2 countries
Study dates
Sep 2008to Jul 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged 18-60 years inclusive
  • Body Mass Index (BMI): BMI in the range of 25.0-34.9 kg/m^2
  • Waist circumference:
  • Females: > 35 inches Males: > 40 inches
  • Diet:
  • Normal eating habits, consuming 3 meals a day (breakfast, lunch and dinner)
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  • Willing to follow a hypocaloric diet during the study to achieve weight loss
  • Willing to take a daily multivitamin for the duration of the study.
  • General Health:Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination

Who cannot join

  • Pregnant and/ or Breast-feeding women
  • Diet/Exercise:Currently on a special diet or who cannot fulfill the dietary requirements of the study.
  • Smoking History:a) Smoking cessation within the past 6 months b) Current Smokers
  • Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials and study foods (or closely related compounds) or any of their stated ingredients.
  • Medication:
  • Currently taking medication for weight loss or appetite control. b) Previous Xenical® (orlistat) or alli® use within 3 months of screening date c) Currently taking medication or supplements that influence intestinal transit time and other stool formation parameters or influences cramping (e.g., Anticholinergics (such as atropine) or cholinergics (such as physostigmine), phenothiazines, tricyclic antidepressants, opioid analgesics (including loperamide), calcium channel antagonists, clonidine, cisapride, octreotide. Also, any laxative or antidiarrheal product). d) Currently taking or withdrawn during the past 6 months any drugs with significant impact on body weight (e.g. serotoninergically acting drugs, antidepressants, central adrenergically acting drugs, drugs inhibiting digestion and absorption, appetite suppressants, metformin) e) Currently taking Cyclosporine, Warfarin or Amiodarone HCL
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  • Disease/Surgery:
  • History of gastrointestinal disease (e.g., irritable bowel syndrome, diarrhea, inflamed bowel, steatorrhea/fat malabsorption, hemorrhoids, incontinence, pancreatitis). b) History of psychological disorder, including eating disorders such as anorexia nervosa and bulimia c) History of neurological disorder (e.g. seizures, parkinson's disease, Alzheimer's disease) d) History of hypo/hyperthyroidism unless euthyroid and controlled on a stable dose of medication for at least 6 months. e) History of surgery for weight loss f) Uncontrolled hypertension g) Heart Disease h) Diabetes Mellitus (Type 1 and 2) (Fasting Blood Glucose >126 mg/dL)
  • Participant has a known history of panic attacks and/or claustrophobia or other conditions precluding safe EchoMRI, CT or other scanning modalities according to local guidelines, (e.g., pacemaker, hearing aid, metallic body piercing and/or other metal implants) or in the opinion of the Investigator the participant exceeds size limitations for the instruments.
  • Participant has had a weight loss or gain of greater than or equal to 3 kg in the 3 months prior to screening.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

  • Duke Clinical Research Unit

    Durham, North Carolina, 27710

Other trials in United States

Sweden1 site

  • Sahlgrenska Academy

    Gothenburg, West Gothland, 405 30

Other trials in Sweden

About this study

Official title: The Effects of Weight Reduction With Orlistat vs. Placebo on Changes in Body Composition

The purpose of this study is to determine if a 24 week weight loss program with orlistat 60 mg will produce greater changes in body composition compared to placebo.

Read the detailed description

Large amounts of VAT (adipose tissue surrounding the viscera of the organs), is known to be associated with increased risk of heart disease and diabetes. Orlistat (tetrahydrolipstatin or THL) inhibits gastrointestinal lipase and reduces the absorption of dietary fat. The purpose of this study is to to determine if a 24 week weight loss program with orlistat 60 mg would produce greater changes in adipose tissue depots (specifically VAT) compared to placebo. This study will use the Echo MRI technology across multiple sites to measure total fat mass. EchoMRI is a non invasive method ideally suited for studies which track changes in human body composition over time, with measuring times of less than 3 minutes and no radiation exposure.

Conditions
Obesity, Overweight
Being tested
Orlistat, Placebo
Keywords
overweight, orlistat, body composition
Medical subject headings
Obesity, Overweight

What participants receive

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

  • OrlistatDrug

    Weight loss treatment

  • PlaceboDrug

    Inactive

Study groups in NCT00752726
Study groupRoleWhat they receive
OrlistatActive comparatorOrlistat 60 milligram (mg) capsules to be consumed orally with each meal 3 times per day
Receives: Drug: Orlistat
PlaceboPlacebo comparatorPlacebo to match Orlistat 60 mg capsules to be consumed orally with each meal 3 times per day.
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline to Week 24 in Abdominal VAT Mass

    VAT was measured by the computed tomography (CT) scan.

    Measured: Baseline to week 24

Secondary outcomes (10)

  1. Change From Baseline to Week 12 in Abdominal VAT Mass

    Abdominal VAT mass from baseline to week 12 was measured by CT scan.

    Measured: Baseline to week 12

  2. Change From Baseline to Week 24 in Body Weight

    Participants were weighed at least twice until two consecutive measurements were within 0.5 kg of each other and the average of the two measurements was recorded.

    Measured: Baseline to week 24

  3. Change From Baseline to Week 24 in Total Fat Mass

    Change in total fat mass was calculated from an average of three measurements at each visit from Echo Magnetic Resonance Imaging (EchoMRI).

    Measured: Baseline to week 24

  4. Change From Baseline to Week 24 in Percentage Body Fat

    Body fat was assessed through Bioelectrical Impedance Analysis (BIA).

    Measured: Baseline to week 24

  5. Change From Baseline to Week 24 in Waist Circumference

    Waist circumference was measured against the skin, without interference from clothing, at the level midway between the lateral lower rib margin and the iliac crest in standing position.

    Measured: Baseline to week 24

  6. Change From Baseline to Week 24 in Percentage Liver Fat

    For Liver fat, Intrahepatic lipids (IHL) were measured by Magnetic Resonance Spectroscopy (MRS).

    Measured: Baseline to week 24

  7. Change From Baseline to Week 24 in Liver Fat

    The liver fat was measured by CT scan in Hounsfield Units (HU).

    Measured: Baseline to week 24

  8. Change From Baseline to Week 24 in Total Calories Expended for Physical Activity

    Measurement of physical activity from Paffenbarger questionnaire. The number of caloried expended was representation of activity level: Higher calorie counts indicate higher activity

    Measured: Baseline to week 24

  9. Change From Baseline to Week 24 in Quality of Life (QoL) Scores.

    QoL scores were measured using an Impact of Weight Quality of Life (IWQoL) Questionnaire, which scored the responses at a scale of 1 to 5(1, never true, to 5, always true): QoL scales for physical function, self-esteem, sexual life, public distress, and work were evaluated, and summarized in a total score. A higher value indicated a better quality of life.

    Measured: Baseline to week 24

  10. Selectivity Index at Week 24

    The selectivity index (SI) was used as a measure of orlistat's ability to target abdominal VAT loss compared to total adipose tissue lost. SI was calculated using the following equation: Mean % change in VAT divided by Mean % change in total fat mass.

    Measured: Baseline to week 24

Timeline

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

  1. First posted15 Sep 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionJul 2009
  4. Study completionJul 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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00752726
Sponsor's protocol ID
W3600586
Status last verified
Feb 2013
First submitted
11 Sep 2008
Last updated
8 Mar 2013
Data monitoring committee
No

Publications

  • Smith SR, Stenlof KS, Greenway FL, McHutchison J, Schwartz SM, Dev VB, Berk ES, Kapikian R. Orlistat 60 mg reduces visceral adipose tissue: a 24-week randomized, placebo-controlled, multicenter trial. Obesity (Silver Spring). 2011 Sep;19(9):1796-803. doi: 10.1038/oby.2011.143. Epub 2011 Jun 30.

    PubMed 21720429

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Orlistat in people with Obesity and Overweight, run by GlaxoSmithKline at 3 sites in 2 countries.

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 9 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 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Sweden. 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 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?

Yes. Results are posted in the registry (first posted 7 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline to Week 24 in Abdominal VAT Mass (time frame: Baseline to week 24). 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 NCT00752726, 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 8 Mar 2013.

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