Obesity
Conditions
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.
Interventions
DRUGoleoyl-estrone (MP 101)
Sponsors
Manhattan Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the preliminary efficacy | — |
Countries
Switzerland, United States
Outcome results
None listed