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

June 4, 2007 updated by: Manhattan Pharmaceuticals

A Phase 2a Randomized, Double-Blind, Placebo Controlled, Parallel Group, Safety and Efficacy Study of Oleoyl-Estrone (MP-101) in Male Obese Adults.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • St. Luke's-Roosevelt Hospital
    • Texas
      • Dallas, Texas, United States, 75234
        • Research Across America
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the safety and tolerability

Secondary Outcome Measures

Outcome Measure
To evaluate the preliminary efficacy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manhattan Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Registration Dates

First Submitted

March 16, 2007

First Submitted That Met QC Criteria

March 16, 2007

First Posted (Estimate)

March 20, 2007

Study Record Updates

Last Update Posted (Estimate)

June 5, 2007

Last Update Submitted That Met QC Criteria

June 4, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAN-OE-US-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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