Updated on 23 November 2020




A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaluate the effect of long-term treatment with BELVIQ (Lorcaserin HCl) on the incidence of major adverse cardiovascular events and conversion to Type 2 Diabetes Mellitus in obese and overweight subjects with Cardiovascular Disease or Multiple Cardiovascular risk factors

IRB Number: 014-016

Legacy Heart Center

6601 Preston Road

Plano, TX 75024

Lead Principal Investigator: Marcus McKenzie, MD

Clinical Study IdentifierTX138930
Last Modified on23 November 2020

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Inclusion Criteria

Gender: Male or Female
BMI greater than or equal to 27 kg/m^2
Subjects able and willing to comply with a reduced-calorie diet and an increased physical activity program
Age greater than or equal to 40 years with established CV disease as defined by one of the following
History of documented MI or ischemic stroke
History of peripheral artery disease
History of revascularization (coronary, carotid, or peripheral artery)
Significant unrevascularized coronary arterial stenosis OR age greater than or equal to 55 years for women or greater than or equal to 50 years for men who have Type 2 Diabetes Mellitus without established CV disease plus at least one of the following CV risk factors
Hypertension, or currently receiving therapy for documented hypertension
Dyslipidemia, or currently taking prescription lipid-lowering therapy for documented dyslipidemia

Exclusion Criteria

Moderate or greater symptoms of congestive cardiac failure (New York Heart Association [NYHA] class III or IV)
Moderate renal impairment, severe renal impairment, or end stage renal disease (ESRD)
Severe hepatic impairment
Use of other products intended for weight loss including prescription drugs, over-the-counter (OTC) drugs, and herbal preparations
History or evidence of clinically significant disease (e.g., malignancy, cardiac, respiratory, gastrointestinal, renal or psychiatric disease)
Use of lorcaserin HCl prior to Screening or hypersensitivity to lorcaserin HCl or any of the excipients
Planned bariatric surgery
Females must not be breastfeeding or pregnant
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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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