Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults
A Phase 2a Randomized, Double-Blind, Placebo Controlled, Parallel Group, Safety and Efficacy Study of Oleoyl-Estrone (MP-101) in Male Obese Adults.
1 other identifier
interventional
24
1 country
3
Brief Summary
Multi-center, multiple-dose, randomized, double-blind, three-arm, placebo-controlled study of fixed-dose repeated oral dosing for 30 days of 10 mg and 30 mg MP-101 and placebo in obese subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 obesity
3 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
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 16, 2007
CompletedFirst Posted
Study publicly available on registry
March 20, 2007
CompletedJune 5, 2007
June 1, 2007
March 16, 2007
June 4, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and tolerability
Secondary Outcomes (1)
To evaluate the preliminary efficacy
Interventions
Eligibility Criteria
You may qualify if:
- Subject is willing and able to provide signed informed consent.
- Subject is a male and is between 18-60 years of age.
- Subject is obese as defined as a BMI of 40 - 55.
- Subject is reasonably healthy and have a reasonably acceptable medical history
- Subject has a stable weight for the past 30 days per subject report.
- Subject who has at least one factor of the metabolic
- Subject exhibits stable behavior patterns with regard to smoking and exercise
- Subject can read, speak and write the English language and agrees to follow study procedures.
You may not qualify if:
- Subjects who have received any investigational medication within 3 months prior to administration of study drug
- Subjects with confirmed positive results of UDS or Alcohol
- Subjects who are unwilling to return to the clinical research center on specified days during the treatment periods.
- Subjects with any clinically significant laboratory abnormality or illness which, in the opinion of the Investigator, would contraindicate study participation
- Subjects who have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV.
- Subject has been involved in a formal or informal (self-imposed) diet regimen within the last 30 days.
- Subject has a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer.
- Subject is otherwise unsuitable for the study, in the opinion of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
St. Luke's-Roosevelt Hospital
New York, New York, 10025, United States
Research Across America
Dallas, Texas, 75234, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 16, 2007
First Posted
March 20, 2007
Study Start
October 1, 2006
Last Updated
June 5, 2007
Record last verified: 2007-06