Status:
COMPLETED
To Assess the Effect of Lorcaserin Hydrochloride on Energy Metabolism and Food Intake
Lead Sponsor:
Eisai Inc.
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and food intake in obese and overweight patients.
Eligibility Criteria
Inclusion
- Males or females aged between 18 and 65 years (inclusive)
- Body Mass Index (BMI) is 27.0 to 45.0 kg/m2, inclusive
- Able to give signed informed consent
- Ambulatory and able to perform exercise program (Arena Healthy Lifestyle Program, see Appendix 1)
- Eligible male and female patients must agree not to participate in a conception process
- Considered to be in stable health in the opinion of the Investigator
Exclusion
- Prior participation in any study of lorcaserin.
- Participants who are current smokers or have smoked within the previous 6 months. No smoking will be allowed during the study.
- Clinically significant new illness in the 1 month before screening
- Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
- Recent history (within 6 months before entering the study) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication. SSRI's, SNRI's, and other medications must meet washout requirements.
- Significant dislike or allergy to foods used during the food intake tests
- History of any of the following cardiovascular conditions:
- Myocardial infarction (diagnosed by cardiac enzyme\[s\] and/or diagnostic ECG), CVA, TIA or RIND within 3 months of screening; cardiac arrhythmia requiring medical or surgical treatment within 3 months of screening
- Unstable angina
- History of congestive heart failure caused by insufficiency, damage, or stenosis of any heart valve
- History of pulmonary artery hypertension
- Positive result of HIV, hepatitis B or hepatitis C screens
- Recent treatment (i.e., within 1 month of the screening visit) with over-the-counter weight loss products or appetite suppressants (including herbal weight loss agents), or within 3 months with a prescription anti-obesity drug (e.g., phentermine, sibutramine, orlistat)
- Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00829140
Start Date
November 1 2008
End Date
February 1 2010
Last Update
September 12 2019
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808