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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Manhattan Pharmaceuticals
• Treatments: Estrone; Estropipate; Oleoyl-estrone

Criteria

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.