To Assess the Effect of Lorcaserin Hydrochloride on Energy Metabolism and Food Intake

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and food intake in obese and overweight patients.

Official Title
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A 56-Day , Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Effect of Lorcaserin Hydrochloride on Energy Metabolism and Food Intake in Overweight and Obese Patients (TULIP)

Conditions
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Obesity

Intervention / Treatment
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* Drug: Placebo
* Drug: Lorcaserin 10mg BID


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo BID<br> | Drug: Placebo<br> <br> |
| Experimental: Lorcaserin 10mg BID<br> | Drug: Lorcaserin 10mg BID<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of lorcaserin on 24h energy metabolism (measured in a respiratory chamber) after 56 days of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the ongoing safety of lorcaserin |  |  |