Weight Loss MedDRA version: 9.1 Level: LLT Classification code 10047900 Term: Weight loss
Conditions
Interventions
Trade Name: alli (Orlistat 60mg Capsules)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ORLISTAT
CAS Number: 96829582
Current Sponsor code: orlistat
Other descriptive name: tetrahydrolipstat
Sponsors
GlaxoSmithKline Consumer Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-60 years inclusive 2. Body mass index (BMI): BMI in the range 25.0-34.9 kg/m2 3. Waist circumference: Females > 35 " and Males > 40" 4. Diet: a) Normal eating habits, consuming 3 meals/day (breakfast, lunch & dinner) b) Willing to follow a hypocaloric diet during the study to achieve weight loss c) Willing to take a multivitamin for the duration of the study. 5. Contraception: Females of childbearing potential practicing an acceptable method of contraception or surgically sterile 6. Compliance: a) Understands and is willing, able and likely to comply with all study procedures and restrictions b) Has the ability to swallow dosages in capsule form 7. Consent: Demonstrates understanding of study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form 8. General Health: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy: Women who are known to be pregnant, have a positive pregnancy test, or who are intending to become pregnant over the duration of the study 2. Breast-feeding: Women who are breast-feeding 3. Diet/exercise: Currently on a special diet or who cannot fulfill the dietary requirements of the study 4. Smoking History: a) Smoking cessation within the past 6 months b) Current smokers 5. Allergy/tolerance: Known or suspected intolerance or hypersensitivity to the study materials and study foods (or closely related compounds) or any of their stated ingredients 6. Medication: a) Currently taking medication for weight loss or appetite control b) Previous Xenical® (orlistat 120mg) or alli® (orlistat 60mg) 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, opiod 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 (3.g., serotoninergically acting drugs, antidperssants, central adrenergially acting drugs, drugs inhibiting digestion and absorption, appetite suppressants, metformin) e) Currently taking Cyclosporine, Warfarin or Amiodarone HCl 7. Disease/Surgery: a) History of GI 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) 8. Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study b) Previous participation in this study 9. Substance abuse: Subject has a recent history (within the last 2 years) of alcohol or other substance abuse 10. Subject has a positive urine drug test for cannabinoids, opiates, amphetamines or cocaine at screening 11. Personnel: Subject is an employee of the sponsor or the direct clinical unit, and/or is a friend or family member of an employee of the clinical unit 12. Subject 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 subject exceeds size limitations for the instruments 13. Subject has had a weight loss or gain of > or = to 3 kg in the 3 months prior to screening 14. Subject has had previous radiation exposure within the past year (e.g. diagnostic or medical tests) which, in the opinion of the investigator, would preclude subject participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether a 24 week weight loss program with orlistat will produce a greater reduction from baseline in abdominal visceral adipose tissue (VAT) mass compared to placebo in overweight and class I obese subjects.;Primary end point(s): Abdominal visceral adipose tissue mass change from baseline to week 24;Secondary Objective: To determine whether a 24 week weight loss program with orlistat will produce greater changes from baseline compared to placebo in overweight and class I obese subjects in the following variables at measured time-points: body weight, abdominal VAT mass at additional time point, total fat mass, liver fat (IHL), waist circumferance, % body fat, physical activity and quality of life. To determine the selectivity index of orlistat To assess safety and tolerability of orlistat | — |
Countries
Sweden
Outcome results
None listed