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

Completed · Phase 4 · Has a placebo group

Conditions studied: Cardiovascular Disease, High Cardiovascular Risk, Obesity, Overweight, Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT02019264

Run by

Eisai Inc.

People needed

14673

Starts

2014-01-24

Expected to finish

2018-05-14

Last updated by the study team

2019-07-16

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BMI greater than or equal (>=) to 27 kilogram per meter square (kg/m\^2)
• Subjects able and willing to comply with a reduced-calorie diet and an increased physical activity program
• Age >= 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 >= 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:
• Hypertension, or currently receiving therapy for documented hypertension
• Dyslipidemia, or currently taking prescription lipid-lowering therapy for documented dyslipidemia
• 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
• High high sensitivity C-reactive protein (hsCRP)
• 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.

You may not qualify if…

• Moderate or greater symptoms of congestive cardiac failure (New York Heart Association [NYHA] class III or IV)
• Known left ventricular (LV) ejection fraction < than 20%
• Moderate or greater symptoms of pulmonary hypertension (PH)
• Known severe valvular disease
• 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)
• Severe hepatic impairment
• Use of other products intended for weight loss including prescription drugs, over-the-counter (OTC) drugs, and herbal preparations
• Use of more than one other serotonergic drug
• 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
• 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

Where it is running

• North Alabama Research Center, LLC — Athens, Alabama, United States
• UAB Medical Center — Birmingham, Alabama, United States
• Coastal Clinical Research, Inc. — Mobile, Alabama, United States
• Mobile Heart Specialists, PC — Mobile, Alabama, United States
• Alaska Heart Institute — Anchorage, Alaska, United States
• Connect Clinical Research Center, LCC — Chandler, Arizona, United States
• Arrowhead Health Centers — Glendale, Arizona, United States
• Phoenix Heart, PLLC — Glendale, Arizona, United States
• Eclipse Clinical Research — Tucson, Arizona, United States
• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• Arkansas Cardiology Clinic — Little Rock, Arkansas, United States
• Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States
• Preferred Research Partners — Little Rock, Arkansas, United States
• Clinical Research Alliance — Alhambra, California, United States
• Central Cardiology — Bakersfield, California, United States
• Cardiovascular Research Foundation of Southern Cal — Beverly Hills, California, United States
• Capitol Interventional Cardiology — Carmichael, California, United States
• San Diego Costal Endocrinology Group AMC — Chula Vista, California, United States
• John Muir Physician Network Clinical Research Cent — Concord, California, United States
• Medical Group of Encino — Encino, California, United States
• Marin Endocrine Care & Research, Inc. — Greenbrae, California, United States
• California Heart Specialists — Huntington Beach, California, United States
• Del Rosario Medical Clinic, Inc. — Huntington Park, California, United States
• Diabetes and Endocrine Associates — La Mesa, California, United States
• Advanced Cardiovascular, LLC — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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