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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00449202
• Other study ID #: MAN-OE-OS-03
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 16, 2007
• Last updated: March 16, 2007
• Start date: June 2006

Study information

• Verified date: March 2007
• Source: Manhattan Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• oleoyl-estrone (MP 101)

Locations

Country	Name	City	State
Switzerland	Swiss Pharma Contract	Basel
United States	Pennington Biomedical Research	Baton Rouge	Louisiana
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Manhattan Pharmaceuticals

Countries where clinical trial is conducted

United States,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability
Secondary	To evaluate the preliminary efficacy