Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults
This trial is active, not recruiting.
|Start date||October 2006|
|Trial size||24 participants|
|Trial identifier||NCT00449254, MAN-OE-US-04|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
To evaluate the safety and tolerability
To evaluate the preliminary efficacy
Male participants from 18 years up to 60 years old.
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.
|Official title||A Phase 2a Randomized, Double-Blind, Placebo Controlled, Parallel Group, Safety and Efficacy Study of Oleoyl-Estrone (MP-101) in Male Obese Adults.|
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