Methods Study to Characterize Early Indicators of Weight Loss in People
A Randomized, Open-Label, Parallel Group, Fixed Energy Deficit Methodology Trial to Characterize Early Efficacy Biomarkers During Treatment of Obesity in Adult, Obese, Male Subjects.
1 other identifier
interventional
57
1 country
2
Brief Summary
Methods study to characterize early indicators of weight loss in people.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Oct 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedFirst Posted
Study publicly available on registry
October 3, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedMarch 23, 2009
March 1, 2009
September 29, 2006
March 20, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the effect of varying degrees of controlled, 1-month, caloric restriction on weight loss, and response of known circulating, candidate biomarkers
Throughout trial
Secondary Outcomes (1)
To evaluate the time course, magnitude and biomarkers of metabolic compensation as well as assessment of well being (via questionnaires) following varying degrees of controlled, 1-month, caloric restriction
Throughout trial
Study Arms (4)
10%
EXPERIMENTAL25%
EXPERIMENTAL50%
EXPERIMENTALControl
PLACEBO COMPARATORInterventions
Subjects maintained on 10% caloric restriction (caloric intake = 90% of baseline)
Subjects maintained on 25% caloric restriction (caloric intake = 75% of baseline)
Subjects maintained on 50% caloric restriction (caloric intake = 50% of baseline)
Subjects maintained on their baseline caloric intake (caloric restriction = none)
Eligibility Criteria
You may qualify if:
- Subjects \>=18 years of age with BMI \>= 30 and \< 40 kg/m2
You may not qualify if:
- Females, those with illnesses expected to cause weight loss, those without stable body weight within 3 months of screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- University of Adelaidecollaborator
- Royal Adelaide Hospitalcollaborator
Study Sites (2)
Pfizer Investigational Site
Adelaide, South Australia, 5000, Australia
Pfizer Investigational Site
North Adelaide, South Australia, 5006, Australia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 29, 2006
First Posted
October 3, 2006
Study Start
October 1, 2006
Study Completion
March 1, 2008
Last Updated
March 23, 2009
Record last verified: 2009-03