Title
Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)
A Phase 2a Randomized, Double-Blind, Placebo Controlled, Parallel Group, Safety and Efficacy Study of Two 14 Day Cycles of Oral Doses of Oleoyl-Estrone (MP-101) in Obese Adult Subjects
Phase
Phase 2Lead Sponsor
Manhattan PharmaceuticalsStudy Type
InterventionalStatus
Unknown statusIndication/Condition
ObesityIntervention/Treatment
oleoylestrone ...Study Participants
100The 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.
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