Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults
Phase 2
- Conditions
- Obesity
- Registration Number
- NCT00449254
- Lead Sponsor
- Manhattan Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 who have taken exclusionary medication
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability
- Secondary Outcome Measures
Name Time Method To evaluate the preliminary efficacy
Trial Locations
- Locations (3)
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States
St. Luke's-Roosevelt Hospital
🇺🇸New York, New York, United States
Research Across America
🇺🇸Dallas, Texas, United States