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
Condition: Cardiovascular Disease; High Cardiovascular Risk; Obesity; Overweight; Type 2 Diabetes
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Intervention: Lorcaserin hydrochloride; Placebo
Intervention description: APD356 10 mg twice daily; Placebo twice daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14673.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Diabetes; Cardiovascular Disease; Multiple Cardiovascular Risk Factors; Obesity; Overweight; MACE; Conversion to Diabetes

Summary:

      This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in
      overweight and obese subjects with cardiovascular (CV) disease and/or multiple CV risk
      factors.
    

Eligibility criteria:

        Inclusion Criteria

          1. BMI greater than or equal (>=) to 27 kilogram per meter square (kg/m^2)

          2. Subjects able and willing to comply with a reduced-calorie diet and an increased
             physical activity program

          3. Age >= 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 >= to 55 years for women or >= to 50 years for men who have type 2 diabetes mellitus
        (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. Estimated glomerular filtration rate >= to 30 to less than equal (<=) to 60 mililitre
             per minute per 1.73 meter square (mL/min/1.73 m^) per the Chronic Kidney Disease
             Epidemiology Collaboration (CKD-EPI) equation

          4. High high sensitivity C-reactive protein (hsCRP)

          5. Urinary albumin-to-creatinine ratio (ACR) >= 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 < than 20%

          3. Moderate or greater symptoms of pulmonary hypertension (PH)

          4. Known severe valvular disease

          5. Moderate renal impairment, severe renal impairment (estimated glomerular filtration
             rate < 30 mL/min/1.73 m^ per the CKD-EPI equation based on ideal body weight), or end
             stage renal disease (ESRD)

          6. Severe hepatic impairment

          7. Use of other products intended for weight loss including prescription drugs,
             over-the-counter (OTC) drugs, and herbal preparations

          8. Use of more than one other serotonergic drug

          9. Use of drugs known to increase the risk for cardiac valvulopathy within 6 months prior
             to Screening including, but not limited to: pergolide, ergotamine, methysergide,
             cabergoline

         10. History or evidence of clinically significant disease (e.g., malignancy, cardiac,
             respiratory, gastrointestinal, renal or psychiatric disease)

         11. Use of lorcaserin HCl prior to Screening or hypersensitivity to lorcaserin HCl or any
             of the excipients

         12. Planned bariatric surgery

         13. Females must not be breastfeeding or pregnant