Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)

Manhattan Pharmaceuticals

Status and phase

Unknown

Phase 2

Conditions

Obesity

Treatments

Drug: oleoyl-estrone (MP 101)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00449202

MAN-OE-OS-03

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult subjects.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Be a male or female between the ages of 18 and 65 years, inclusive
Female subjects must be either surgically sterile or at least 2 years postmenopausal
Have a BMI of 27 - 38.9, inclusive
Have a stable weight for the past 30 days per subject report
Be otherwise healthy and have an acceptable medical history
Have negative urinalysis test results for drugs of abuse and alcohol
Have the ability to understand the requirements of the study, have provided written informed consent and agree to abide by the study restrictions
Exhibit stable behavior patterns with regard to smoking and exercise
Subject who has at least one factor of the metabolic syndrome

Exclusion criteria

Be pregnant or nursing
Have taken exclusionary medication in the past 30 days
Have any clinically significant abnormal laboratory test as determined by the investigator
Have a clinically significant illness during the 30 days before enrollment
Have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV
Have a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer
Have a previous diagnosis of diabetes
Be otherwise unsuitable for the study, in the opinion of the investigator
Have an allergy to safflower seeds or its byproducts (e.g., safflower oil)
Have any postmenopausal bleeding within the last 6 months
Have been involved in a formal or informal (self-imposed) diet regimen within the last 30 days
Currently working night shifts
Have a history of known multiple miscarriages