Obesity
Conditions
Brief summary
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.
Interventions
DRUGoleoyl-estrone (MP-101)
Sponsors
Manhattan Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the preliminary efficacy | — |
Countries
United States
Outcome results
None listed