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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Interventions

  • Drug: oleoyl-estrone (MP 101)

Clinical Trial Outcome Measures

Primary Measures

  • To evaluate the safety and tolerability

Secondary Measures

  • To evaluate the preliminary efficacy

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Manhattan Pharmaceuticals

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