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UNKNOWNPHASE2

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

NCT00449202•Manhattan Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

Locations (3)

Pennington Biomedical Research

Baton Rouge, Louisiana, United States

Jean Brown Research

Salt Lake City, Utah, United States

Swiss Pharma Contract

Basel, Switzerland

Key Dates

Start Date

June 1, 2006

Last Updated

March 20, 2007

Enrollment

100

Estimated participants

Conditions

Obesity

Interventions

oleoyl-estrone (MP 101)

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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