This trial is active, not recruiting.

Condition obesity
Treatment oleoyl-estrone (mp 101)
Phase phase 2
Sponsor Manhattan Pharmaceuticals
Start date June 2006
Trial size 100 participants
Trial identifier NCT00449202, MAN-OE-OS-03


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

To evaluate the safety and tolerability
time frame:

Secondary Outcomes

To evaluate the preliminary efficacy
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in March 2007.
Information provided to ClinicalTrials.gov by Manhattan Pharmaceuticals.