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A Two Part Trial Investigating an Anti-obesity Drug ('2-0453) in Overweight/Obese Male and Female Healthy Volunteers - NCT01044108-47710(Clinical Trial 464255)



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City:  Evansville
State:  
IN
Zip Code: 47710
Conditions: Healthy - Obesity
Purpose: This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability, efficacy and pharmacokinetics (exposure of drug) of '2-0453 in overweight/obese, but otherwise healthy male and female volunteers.
Study summary:
Criteria: Inclusion Criteria: - FOR TRIAL PART 1, THE FOLLOWING APPLIES: - Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject - Overweight/obese males: Body Mass Index (BMI) between 27.0 to 39.0 kg/m2 - Good general health - FOR TRIAL PART 2, THE FOLLOWING APPLIES: - Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject. - Obese male and female subjects: Body Mass Index (BMI) between 30.0 to 39.0 kg/m2 - Good general health. Exclusion Criteria: - Aggressive diet attempts within the last 3 months - Current or history of treatment with medications that may cause significant weight gain - History of major depressive disorder or history of a suicide attempt or history of any suicidal behaviour - History of eating disorders - Any weight change of 5 kg (11 pounds) in the last 3 months - Tobacco use - History of alcoholism or drug/chemical abuse
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Data Source: ClinicalTrials.gov
Date Processed: July 12, 2010
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