NCT00752726

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P75+ for phase_4 obesity

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_4 obesity

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

February 7, 2013

Completed
Last Updated

March 8, 2013

Status Verified

February 1, 2013

Enrollment Period

10 months

First QC Date

September 11, 2008

Results QC Date

July 21, 2010

Last Update Submit

February 28, 2013

Conditions

ObesityOverweight

Keywords

overweight, orlistat, body composition

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to Week 24 in Abdominal VAT Mass

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

    Baseline to week 24

Secondary Outcomes (10)

  • Change From Baseline to Week 12 in Abdominal VAT Mass

    Baseline to week 12

  • Change From Baseline to Week 24 in Body Weight

    Baseline to week 24

  • Change From Baseline to Week 24 in Total Fat Mass

    Baseline to week 24

  • Change From Baseline to Week 24 in Percentage Body Fat

    Baseline to week 24

  • Change From Baseline to Week 24 in Waist Circumference

    Baseline to week 24

  • +5 more secondary outcomes

Study Arms (2)

Orlistat

ACTIVE COMPARATOR

Orlistat 60 milligram (mg) capsules to be consumed orally with each meal 3 times per day

Drug: Orlistat

Placebo

PLACEBO COMPARATOR

Placebo to match Orlistat 60 mg capsules to be consumed orally with each meal 3 times per day.

Drug: Placebo

Interventions

OrlistatDRUG

Weight loss treatment

Orlistat
PlaceboDRUG

Inactive

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Duke Clinical Research Unit

Durham, North Carolina, 27710, United States

Location

Sahlgrenska Academy

Gothenburg, West Gothland, 405 30, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 21720429BACKGROUND

MeSH Terms

Conditions

ObesityOverweight

Interventions

Orlistat

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic Chemicals

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 15, 2008

Study Start

September 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

March 8, 2013

Results First Posted

February 7, 2013

Record last verified: 2013-02

Locations

US(2)SE(1)