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: tetrahydolipstati
Sponsors
GlaxoSmithKline Consumer Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy male or female between 18 and 60 years of age (inclusive) 2) Healthy as determined by a responsible physician, based on a medical evaluation including medical history and physical examination (including ECGs) 3) BMI within the range of : 20-32 kg/m2 inclusive (PartI), 25-34.90kg/m2 inclusive (PartII). Approximately 1/3 of subjects BMI between 25.0-27.9 kg/m2, Approximately 2/3 of subjects BMI between 28.0-34.9 kg/m2 4) Waist circumference (PartII): Females > 35 inches, Males > 40 inches 5) Normal eating habits, consuming 3 meals a day (breakfast, lunch and dinner) and willing to follow a reduced calorie, low fat diet during the study to achieve weight loss (Part II). 6) Females of childbearing potential who are, in the opinion of the investigator, practicing an acceptable method of contraception (used consistently for at least 3 months prior to study initiation) or surgically sterile. Acceptable methods of birth control include condom or diaphragm with spermicide, depo provera contraceptive injections, implanted contraceptive, oral contraceptive, transdermal patch, intrauterine devices, vasectomized partner and abstinence. Vasectomy must be = 6 months prior to study initiation. 7) Able to swallow dosages in capsule form (Part II). 8) Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. 9) Participants must read (in English) at a level sufficient to adequately complete study related questionnaires. 10) Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions. 11) Registered with a UK general practitioner. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Pregnant females as determined by positive urine hCG test at screening and prior to each MRI scanning session. 2) Women who are breast-feeding. 3) Subjects who are currently on a special diet or who cannot fulfil the dietary requirements of the study (Part II) 4) Current smoker or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. (Part II) 5) The subject has a known or suspected intolerance or hypersensitivity to the study medication (or closely related compounds) or any of the stated ingredients. (Part II) 6) Use of prescription or non-prescription drugs including additional vitamins (other than the vitamins that will be given to the volunteers during the study), herbal & dietary supplements (including St John’s Wort) and the use of medication for weight loss or appetite control (unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety); (Part II) • For example, previous Xenical ® (orlistat) use within 3 months of the screening date. • Use of medication or supplements that influence intestinal transit time, other stool formation parameters e.g. Anticholinergics (such as atropine) or cholinergics (such as physostigmine), phenothiazines, tricyclic antidepressants, opioid analgesics (including loperamide), calcium channel antagonists, clonidine, cisapride, octreotide and any laxative or antidiarrheal product. • Use of drugs with significant impact on body weight within 6 months prior to the screening visit (e.g. serotoninergically acting drugs, antidepressants, central adrenergically acting drugs, drugs inhibiting digestion and absorption, appetite suppressants and metformin. • Use of Cyclosporine, warfarin or Amiodarone HCL. 7) History of any of the following medical conditions/surgical procedures; (Part II) • Gastrointestinal disease (e.g., irritable bowel syndrome, diarrhea, inflamed bowel, steatorrhea/fat malabsorption, hemorrhoids, incontinence, pancreatitis). • Psychological disorder, including eating disorders such as anorexia nervosa and bulimia. • Neurological disorder (e.g. seizures, parkinson’s disease, Alzheimer’s disease). • Hypo/hyperthyroidism unless euthyroid and controlled on a stable dose of medication for at least 6 months. • History of surgery for weight loss, uncontrolled hypertension, heart disease and diabetes mellitus (Type 1 and 2) (fasting blood glucose>126mg/dL). 8) The subject has participated in a clinical trial and has received an investigational product within 30 days prior to the first dosing day in the current study (excluding subjects who have previously completed Part I of this study). (Part II) 9) The subject has a positive pre-study drug test for cannabinoids, opiates, amphetamines or cocaine at screening. (Part II). 10) A recent history (within two years) of alcohol or drug abuse of commencing the study. (Part II) 11) A positive alcohol breath test or urine drug screen at the study screening visit. (Part II) 12) Subject is a GSK employee, contractor currently working for GSK, or an immediate family member of a GSK employee. 13) Subject has had a weight loss or gain of ?3 kg in the 3 months prior to screening (Part II only). 14) Contraindications to MRI scanning including, but not limited to: • Intracranial aneurism clips (except Sugita); • History of intra-orbital metal fragments that have not been removed by an MD (as confirmed by orbital X-r
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the use of MRI to assess change-from-baseline in visceral adipose tissue in overweight volunteers following 3 months of orlistat 60mg and a reduced calorie, low fat diet.;Secondary Objective: To examine the change from baseline of subcutaneous and intermuscular adipose tissue, as well as pericardial fat and ectopic fat depots such as intrahepatic lipids. ;Primary end point(s): Abdominal visceral fat volume | — |
Countries
United Kingdom
Outcome results
None listed