Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults

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.