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

Manhattan Pharmaceuticals

Status and phase

Unknown

Phase 2

Conditions

Obesity

Treatments

Drug: oleoyl-estrone (MP-101)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00449254

MAN-OE-US-04

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

Male

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.