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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Manhattan Pharmaceuticals
• Treatments: Estrone; Estropipate; Oleoyl-estrone

Criteria

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