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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orlistat | Active Comparator | Orlistat 60 milligram (mg) capsules to be consumed orally with each meal 3 times per day |
|
| Placebo | Placebo Comparator | Placebo to match Orlistat 60 mg capsules to be consumed orally with each meal 3 times per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orlistat | Drug | Weight loss treatment |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 24 in Abdominal VAT Mass | VAT was measured by the computed tomography (CT) scan. | Baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in Abdominal VAT Mass | Abdominal VAT mass from baseline to week 12 was measured by CT scan. | Baseline to week 12 |
| Change From Baseline to Week 24 in Body Weight |
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Inclusion Criteria:
Females: > 35 inches Males: > 40 inches
Diet:
General Health:Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination
Exclusion Criteria:
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:
a) 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
Disease/Surgery:
a) 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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States | ||
| Duke Clinical Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21720429 | Background | 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. |
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Out of 267 screened participants, 131 were randomized, while 136 participants were considered as screen failures.
This multicentric clinical study was conducted in 2 countries; 2 centres in United States of America (USA) and 1 centre in Sweden.
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| ID | Title | Description |
|---|---|---|
| FG000 | Orlistat 60 Milligram (mg) | Orlistat 60 mg capsules taken orally with meals 3 times per day |
| FG001 | Placebo | Placebo to match orlistat 60 mg capsules taken orally with meals 3 times per day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Orlistat 60 mg | Orlistat 60 mg capsules taken orally with meals 3 times per day. Intent-to-treat (ITT) population was considered for baseline measures. |
| BG001 | Placebo | Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day. ITT population was considered for baseline measures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 24 in Abdominal VAT Mass | VAT was measured by the computed tomography (CT) scan. | This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | kg | Baseline to week 24 |
|
All adverse events encountered or spontaneously reported by the participant following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Orlistat 60 mg | Orlistat 60 mg capsules taken orally with meals 3 times per day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatty/oily stool | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000077403 | Orlistat |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Drug |
Inactive |
|
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.
| Baseline to week 24 |
| 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). | Baseline to week 24 |
| Change From Baseline to Week 24 in Percentage Body Fat | Body fat was assessed through Bioelectrical Impedance Analysis (BIA). | Baseline to week 24 |
| 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. | Baseline to week 24 |
| Change From Baseline to Week 24 in Percentage Liver Fat | For Liver fat, Intrahepatic lipids (IHL) were measured by Magnetic Resonance Spectroscopy (MRS). | Baseline to week 24 |
| Change From Baseline to Week 24 in Liver Fat | The liver fat was measured by CT scan in Hounsfield Units (HU). | Baseline to week 24 |
| 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 | Baseline to week 24 |
| 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. | Baseline to week 24 |
| 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. | Baseline to week 24 |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Sahlgrenska Academy | Gothenburg | West Gothland | 405 30 | Sweden |
| Withdrawal by Subject |
|
| Other Reason |
|
| BG002 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Weight | Mean | Standard Deviation | Kilogram (kg) |
|
| Height | Mean | Standard Deviation | Centimeter (cm) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kilogram per meter square (kg/m^2) |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| Visceral Abdominal Tissue (VAT) Mass | Mean | Standard Deviation | kg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change From Baseline to Week 12 in Abdominal VAT Mass | Abdominal VAT mass from baseline to week 12 was measured by CT scan. | This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | kg | Baseline to week 12 |
|
|
|
|
| Secondary | 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. | This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | kg | Baseline to week 24 |
|
|
|
|
| Secondary | 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). | This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | kg | Baseline to week 24 |
|
|
|
|
| Secondary | Change From Baseline to Week 24 in Percentage Body Fat | Body fat was assessed through Bioelectrical Impedance Analysis (BIA). | This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | Percentage (%) body fat | Baseline to week 24 |
|
|
|
|
| Secondary | 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. | This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | cm | Baseline to week 24 |
|
|
|
|
| Secondary | Change From Baseline to Week 24 in Percentage Liver Fat | For Liver fat, Intrahepatic lipids (IHL) were measured by Magnetic Resonance Spectroscopy (MRS). | ITT subset (participants who had this post-baseline efficacy assessment) from one study site was analysed for this parameter. | Posted | Mean | Standard Deviation | Percentage (%) IHL | Baseline to week 24 |
|
|
|
| Secondary | Change From Baseline to Week 24 in Liver Fat | The liver fat was measured by CT scan in Hounsfield Units (HU). | This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | Hounsfield Units (HU) | Baseline to week 24 |
|
|
|
|
| Secondary | 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 | This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | Kilocalorie (kcal)/week | Baseline to week 24 |
|
|
|
|
| Secondary | 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. | This analysis was carried out for the observed ITT population, i.e. ITT subjects who had this post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline to week 24 |
|
|
|
|
| Secondary | 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. | This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment, only in Orlistat 60 mg group. This analysis was not carried out for placebo group. | Posted | Number | Ratio | Baseline to week 24 |
|
|
|
| 2 |
| 63 |
| 57 |
| 63 |
| EG001 | Placebo | Placebo to match Orlistat 60 mg capsules taken orally with meals 3 times per day | 1 | 64 | 52 | 64 |
| Biliary tract disorder | Hepatobiliary disorders | Systematic Assessment |
|
| Vision blurred | Eye disorders | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
|
| Soft stools | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Liquid stools | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Increased defecation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Fecal urgency | Gastrointestinal disorders | Systematic Assessment |
|
| Flatus with discharge | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Oily spotting | Gastrointestinal disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |