Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults
Status unconfirmed · Phase 2
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT00449254
- Run by
- Manhattan Pharmaceuticals
- People needed
- 24
- Starts
- 2006-10-01
- Last updated by the study team
- 2007-06-05
Who can join
Age: 18 and older, up to 60. Sex: male. Healthy volunteers: not accepted.
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 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.
Where it is running
- St. Luke's-Roosevelt Hospital — New York, New York, United States
- Research Across America — Dallas, Texas, United States
- Jean Brown Research — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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