A 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

Approximately 12,000 subjects will be randomized to two treatment groups in a ratio of 1:1,
stratified by the presence of established CV disease (approximately 80%) or CV risk factors
without established CV disease (approximately 20%). Subjects will receive lorcaserin HCl 10
mg BID or placebo BID. The study will consist of 2 phases: Prerandomization and
Randomization. The Prerandomization Phase will last up to 30 days and consist of one visit
during which subjects will be screened for eligibility. The Randomization Phase will consist
of two periods: Treatment and Follow-up. The Treatment Period will last for approximately 5
years with approximately 18 visits and Follow-up period is 30 (+ or - 10 days) from the end
of treatment visit.

Inclusion Criteria

1. BMI greater than or equal to 27 kg/m^2

2. Subjects able and willing to comply with a reduced-calorie diet and an increased
physical activity program

3. Age greater than or equal to 40 years with established CV disease as defined by one of
the following:

1. History of documented MI or ischemic stroke

2. History of peripheral artery disease

3. History of revascularization (coronary, carotid, or peripheral artery)

4. 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 T2DM without established CV disease plus at least one of the following CV risk
factors:

1. Hypertension, or currently receiving therapy for documented hypertension

2. Dyslipidemia, or currently taking prescription lipid-lowering therapy for documented
dyslipidemia

3. Calculated creatinine clearance greater than or equal to 30 to less than or equal to
60 mL/min per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

4. High hsCRP

5. Urinary albumin-to-creatinine ratio (ACR) greater than or equal to 30 ug/mg

Subjects with T2DM may have a pre-existing or new diagnosis of T2DM. A new diagnosis of
T2DM (ie, discovered at Screening) should be based on the 2013 American Diabetes
Association (ADA) guidelines.

All T2DM subjects must have an HbA[1c] less than 10% at Screening. If subjects are being
treated, or upon diagnosis need to be treated with antidiabetic agents, the T2DM treatment
regimen must be stable for at least 3 months prior to randomization.

Exclusion Criteria

1. Moderate or greater symptoms of congestive cardiac failure (New York Heart Association
[NYHA] class III or IV)

2. Known left ventricular (LV) ejection fraction less than 20%

3. Moderate or greater symptoms of pulmonary hypertension (PH)

4. Known severe valvular disease Moderate renal impairment, severe renal impairment, or
end stage renal disease (ESRD) (calculated creatinine clearance less than 30 mL/min
per the CKD-EPI equation based on ideal body weight)

5. Severe hepatic impairment

6. Use of other products intended for weight loss including prescription drugs,
over-the-counter (OTC) drugs, and herbal preparations

7. Use of more than one other serotonergic drug

8. Use of drugs known to increase the risk for cardiac valvulopathy prior to Screening
including, but not limited to: cyproheptadine, amoxapine, TCAs, mirtazapine,
pergolide, ergotamine, methysergide, cabergoline

9. History or evidence of clinically significant disease (e.g., malignancy, cardiac,
respiratory, gastrointestinal, renal or psychiatric disease)

10. Use of lorcaserin HCl prior to Screening or hypersensitivity to lorcaserin HCl or any
of the excipients

11. Planned bariatric surgery

12. Females must not be breastfeeding or pregnant