Summary

for people ages 40 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

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

Official Title

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

Details

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.

Keywords

Cardiovascular Disease High Cardiovascular Risk Obesity Overweight Type 2 Diabetes Diabetes Multiple Cardiovascular Risk Factors MACE Conversion to Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Cardiovascular Diseases APD356-Lorcaserin hydrochloride APD356 10 mg

Eligibility

You can join if…

Open to people ages 40 years and up

  1. BMI greater than or equal to 27 kg/m2

  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:
  4. History of documented MI or ischemic stroke
  5. History of peripheral artery disease
  6. History of revascularization (coronary, carotid, or peripheral artery)
  7. 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.

You CAN'T join if...

  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

Locations

  • University of California San Diego
    San Diego California 92103-8765 United States
  • Ritchken and First MD's
    San Diego California 92117 United States
  • Sharp Rees-Stealy Medical Group, Inc.
    San Diego California 92101 United States
  • Diabetes and Endocrine Associates
    La Mesa California 91942 United States
  • La Mesa Cardiac Center
    La Mesa California 91942 United States
  • San Diego Coastal Endocrinology Group AMC
    Chula Vista California 91911-3813 United States
  • Carr Cardiology
    Oceanside California 92056 United States
  • Brigid Freyne MD Inc
    Murrieta California 92563 United States
  • Alliance Research Centers
    Laguna Hills California 92653 United States
  • Clinical Interventions Research Institute
    Mission Viejo California 92692 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eisai Inc.
ID
NCT02019264
Phase
Phase 4
Study Type
Interventional
Last Updated
November 1, 2017