Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)
Phase 2
- Conditions
- Obesity
- Registration Number
- NCT00449202
- Lead Sponsor
- Manhattan Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability
- Secondary Outcome Measures
Name Time Method To evaluate the preliminary efficacy
Trial Locations
- Locations (3)
Swiss Pharma Contract
🇨🇭Basel, Switzerland
Pennington Biomedical Research
🇺🇸Baton Rouge, Louisiana, United States
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States