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 (CAMELLIA-TIMI)
Cardiovascular Disease, High Cardiovascular Risk, Obesity

About this trial
This is an interventional treatment trial for Cardiovascular Disease focused on measuring Diabetes, Cardiovascular Disease, Multiple Cardiovascular Risk Factors, Obesity, Overweight, MACE, Conversion to Diabetes
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Sites / Locations
- Advanced Cardiovascular, LLC
- North Alabama Research Center, LLC
- UAB Medical Center
- Coastal Clinical Research, Inc.
- Mobile Heart Specialists, PC
- Alaska Heart Institute
- Connect Clinical Research Center, LCC
- Arrowhead Health Centers
- Phoenix Heart, PLLC
- Eclipse Clinical Research
- NEA Baptist Clinic
- Arkansas Cardiology Clinic
- Central Arkansas Veterans Healthcare System
- Preferred Research Partners
- Clinical Research Alliance
- Central Cardiology
- Cardiovascular Research Foundation of Southern Cal
- Capitol Interventional Cardiology
- San Diego Costal Endocrinology Group AMC
- John Muir Physician Network Clinical Research Cent
- Medical Group of Encino
- Marin Endocrine Care & Research, Inc.
- California Heart Specialists
- Del Rosario Medical Clinic, Inc.
- Diabetes and Endocrine Associates
- La Mesa Cardiac Center
- Alliance Research Centers
- Torrance Clinical Research Institute, Inc.
- Long Beach Center for Clinical Research
- Metabolic Clinic and Research Center
- Beverly Hills Cardiology
- VA Greater Los Angeles Health Care System
- Clinical Interventions Research Institute
- Brigid Freyne MD Inc
- Valley Clinical Trials Inc
- Carr Cardiology
- Northern California Clinical Research Center
- Sharp Rees-Stealy Medical Group, Inc.
- University of California San Diego
- Ritchken and First MD's
- West Coast Research LLC
- Coastal Multi-Specialty Research
- Westlake Medical Research
- Harbor - UCLA Medical Center
- Ronald Chochinov, MD
- Ventura Cardiology Consultants
- Infosphere Clinical Research
- UCH-MHS Cardiac Research
- Creekside Endocrine Associates PC
- New West Physicians, PC
- University of Colorado Health
- Connecticut Clinical Research, LLC
- Bridgeport Hospital
- Clinical Research Works, Bristol
- Cardiology Associates of Fairfield County, Norwalk
- Cardiology Associates of Fairfield County, P.C.
- Stamford Therapeutics Consortium
- Cardiology Associates of Fairfield County, P.C.
- Connecticut Heart and Vascular Center
- Chase Medical Research, LLC
- Red Clay Research
- Alfieri Cardiology
- Aventura Heart Center
- Zasa Clinical Research
- Meridien Research
- NOVA Southeastern University
- Bay Area Cardiology
- Meridien Research, Brooksville
- Clearwater Cardiovascular and Interventional Cons.
- Clinical Research of South Florida
- Holy Cross Medical Group
- Cardiology Research Associates
- International Medical Research
- Asclepius Medical Research
- Fleming Island Center for Clinical Research
- Integrative Research Associates, Inc.
- M & O Clinical Research, LLC
- Primary Care Associates
- Florida Research Network, LLC
- George E. Platt, M.D.
- Eastern Research, Inc.
- Larry K. Levinson, D.O., P.A.
- Research Physicians Network Alliance
- Pasco Cardiology Center
- Nature Coast Clinical Research
- University of Florida- Jacksonville
- Jacksonville Center for Clinical Research
- Westside Center for Clinical Research
- Meridien Research
- Pharmax Research Clinic, Inc
- Life Spring Research Foundation
- United Clinical Research Corp.
- Cardiovascular Research Center of South Florida
- South Florida Research Group LLC
- South Florida Research Solutions
- Southwest Florida Research
- Ocala Research Institute, Inc
- Oviedo Medical Research
- Cardiology Partners Clinical Research Institute
- Palm Beach Gardens Research Center
- Research Physicians Network Alliance, Pembrok
- South Florida Research Solutions
- Cardiology Consultants
- Clinical Research of Central Florida
- Columbia Primary Care, LLC d/b/a Heart and Health Institute
- St Johns Center for Clinical Research
- Charlotte Heart Group Research Center
- Progressive Medical Research
- Brevard Cardiovascular Research Associates Inc
- Clearwater Cardiovascular and Interventional Cons.
- Bayfront Health St. Petersburg, Research
- Meridien Research - St. Petersburg
- Professional Health Care of Pinellas, INC
- Intercoastal Medical Group
- Springfield Medical Center
- Advanced Clinical Research Group
- Meridien Research - Tampa
- Stedman Clinical Trials
- Healthpoint Medical Group, Inc
- Interventional Cardiac Consultants
- Lovelace Scientific Research
- Indian River Medical Center-Cardiology
- Cardiology Partners Clinical Research Institute
- Cleveland Clinic Foundation
- Metabolic Research Institute
- Clinical Research of Central Florida
- Atlanta Diabetes Associates, Endocrinology
- Rockdale Medical-Research Associates
- Atlanta Heart Specialists
- Urban Family Practice Associates/Clinical Research Advantage
- Endocrine Research Solutions, Inc.
- Herman Clinical Research LLC
- Atlanta Heart Specialists
- Northwest Heart Clinical Research, LLC
- Cedar-Crosse Research Center
- Northwestern University Feinberg School of Medicine
- University of Chicago
- Consultants in Cardiovascular Medicine
- Clinical Investigation Specialists, Inc. in Gurnee
- Advanced CardioVascular Consultants, SC
- Community Clinical Research Center
- American Health Network of IN, LLC, Avon
- Premier Healthcare, LLC
- Deaconess Clinic, Inc.
- American Health Network of IN, LLC, Franklin
- American Health Network of IN, LLC, Greenfield
- American Health Network - Thomas Moretto, MD
- Medical Consultants PC
- American Health Network of IN, LLC
- Cardiology Associates of Northwest Indiana, P.C
- The University of Iowa, College of Public Health
- Professional Research Network of Kansas, LLC
- Norton Heart Specialists
- Norton Heart Specialists
- L-MARC Research Center
- Research Integrity LLC
- Central Maine Medical Center
- Acadia Clinical Research, LLC
- Eastern Maine Medical Center Northeast Cardiology Associates
- Southern Maine Health Care/Maine Medical Center Research Ins
- InterMed, PA
- Medstar Cardiology Associates
- Chesapeake Cardiovascular Associates, GBMC
- Clinical Research, Inc
- Medstar Union Memorial Heart Specialists
- Medstar Union Memorial Hospital
- Spectrum Clinical Research
- Overlea Personal Physicians
- Shahid Saeed MD, PC
- Maryland Heart Associates, LLC
- Klein & Associates, MD, PA
- MedStar Health Research Institute
- Lutherville Personal Physicians
- MD Medical Research
- Endocrine & Metabolic Consultants
- Lutherville Personal Physicians
- Overlea Personal Physicians
- Tufts Medical Center
- MGH Weight Center
- Brigham and Women's Hospital
- New England Center for Clinical Research, IMCA
- Pentucket Medical Associates
- ActivMed Practices
- Partners Community Physicians Organization
- Partners Community Physicians Organization
- Endeavor Medical Research PLC
- Cadillac Clinical Research, LLC
- Westside Family Medical Center, PC
- Cardiology Consultants of East Michigan
- Marquette General Heart and Vascular Institute
- MidMichigan Medical Center
- Nisus Research at McLaren Northern Michigan Hospital
- Saint Joseph Mercy Oakland Hospital
- Remedica LLC
- Michigan CardioVascular Institute
- American Center for Clinical Trials
- Medical Research Associates, Inc.
- Michigan Heart
- Minneapolis Heart Institute Foundation
- Essentia Institute of Rural Health
- MNCOME Clinic
- Radiant Research, Inc.
- Minneapolis Heart Institute
- Regions Hospital
- Coast Cardiovascular Consultants PLLC
- Cardiology Associates Research, LLC
- Diabetes & Endocrinology Specialists, Inc.
- BodyAesthetic Research Center
- Billings Clinic Research Center
- Montana Health Research Institute, Inc.
- Glacier View Cardiology PC
- Internal Medical Associates of Grand Island, PC
- Clinical Research Advantage / Rita Chuang, M.D.
- Clinical Research Advantage, Inc.
- Clinical Research of South Nevada
- Medicor Cardiology, PA
- Advanced Heart Care
- UmiMed Center LLC
- Cardiovascular Associates of the Delaware Valley
- Advocare Heights Primary Care
- Cardiovascular Associates of the Delaware Valley P
- NJ Heart
- Rutgers New Jersey Medical School
- Cardiovascular Associates Delaware Valley Sewell
- Cardio Metabolic Institute
- New Mexico Heart Institute, PA
- Albany College of Medicine, Division of Endocrinology
- Capital Cardiology Associates
- United Medical Associates, PC
- James J. Peters VA Medical Center, Bronx, NY
- Buffalo Heart Group
- Regional Clinical Research, Inc.
- Long Island Gastrointestinal Research Group LLP
- Long Island Heart Associates
- North Shore Diabetes and Endocrine Associates
- Weill Cornell Medical College
- DiGiovanna Institute for Medical Education
- Hudson Valley Heart Center
- Rochester Clinical Research, Inc.
- Northwell Health Physician Partners Cardiology
- Capital Cardiology Associates
- Great Lakes Medical Research
- Kernodle Clinic
- Clinical Trials of America Inc.
- Metrolina Internal Medicine
- PMG Research of Charlotte, LLC
- Bland Clinic, PA
- Clinical Trials of America Inc. Hickory
- Clinical Trials of America, Inc.
- Peters Medical Research
- Clinical Trials of America, Inc.
- Diabetes & Endocrinology Consultants
- Burke Primary Care
- Pinehurst Medical Clinic, Inc.
- Wake Research Associates, LLC
- PMG Research of Rocky Mount
- PMG Research of Salisbury
- Sanford Cardiology
- Piedmont Healthcare
- PMG Research of Wilmington
- PMG Research of Winston-Salem, LLC
- Lillestol Research LLC
- Aultman Hospital
- The Lindner Research Center
- Sentral Clinical Research
- Delaware Research Group, LLC
- Awasty Research Network, LLC
- Community Health Care
- Apex Medical Research Inc.
- Integris Cardiovascular Physicians LLC
- Memorial Clinical Research
- South Oklahoma Heart Research, LLC
- Oklahoma Heart Institute
- Vital Prospects Clinical Research Institute PC
- Blair Medical Associates
- Clinical Research Associates of Central PA, LLC
- Capital Area Research, LLC
- Geisinger Health Clinic
- Geisinger Health System
- Doylestown Health Cardiology a Division of Doylestown Health
- Altoona Center for Clinical Research
- Liberty Family Practice
- Endocrine Clinical Research LLC
- Joseph Lamantia, DO
- The Clinical Trial Center, LLC
- Lycoming Internal Medicine, Inc.
- Berkley Hills Clinicals
- Ilumina Clinical Associates, Johnstown
- Joseph Lamantia, DO
- Comprehensive Cardiology Consultants
- Detweiler Family Medicine and Associates PC
- Green & Seidner Family Practice Associates
- Capital Area Research LLC
- Endocrine Metabolic Associates
- Pottstown Medical Specialists, Inc. (PMSI)
- Geisinger Clinic
- Partners in Clinical Research
- Radiant Research, Inc.
- Mountain View Clinical Research
- Palmetto Research Center, LLC
- Brown Clinic, PLLP
- PMG Research of Bristol, LLC
- Chattanooga Research and Medicine (CHARM)
- WR-ClinSearch, LLC
- Wellmont CVA Heart Institute
- Research Associates of Jackson
- Kore Cardiovascular Research
- The Jackson Clinic, PA
- Wellmont CVA Heart Institute
- Holston Medical Group
- Wellmont CVA Heart Institute
- The Endocrine Clinic
- Cardiology Wellness Center
- Central Texas Clinical Research, LLC
- Texas Diabetes & Endocrinology
- Texas Health Physicians Group
- Adriana Pop-Moody MD Clinic, PA
- Baylor Research Institute
- Texas Health Physicians Group
- Texas Health Physicians Group, Dallas
- Research Institute of Dallas
- Odilon Alvarado, M.D.
- Texas Health Physicians Group Fort Worth
- Tand R Clinic, PA
- San Gabriel Clinical Research, LLC
- Angiocardiac Care of Texas PA
- Oxford Clinical Research, LLC
- West Houston Area Clinical Trial Consultants, LLC
- Endocrine and Psychiatry Center
- Texas Health Physicians Group
- Texas Cardiology Associates of Houston
- Jalil Aziz Khan M.D., P.A.
- Midland Clinical Research Center
- Permian Research Foundation
- Medical Clinic of North Texas
- Clinical Investigations of Texas, LLC
- Texas Diabetes
- Physician PrimeCare Research Institute, PLLC
- Cardiology Clinic of San Antonio
- Radiant Research San Antonio
- Martin Diagnostic Clinic
- Cardiovascular Associates of East Texas
- Bay Area Total Health Medical Group
- Advanced Research Institute
- Jean Brown Research
- Alexandria Clinical Research, LLC
- Washington Center for Weight Management and Resear
- Burke Internal Medicine and Research
- Cardiology Consultants of Danville, Inc.
- Danville Internal Medicine, Inc
- Virginia Heart
- Seven Corners Medical Research Center
- INOVA Health Care Services
- Burke Internal Medicine and Research
- Manassas Clinical Research Center
- Health Research of Hampton Roads - Norfolk, Inc.
- Clinical Research Associates of Tidewater
- Clinical Research Partners
- Virginia Cardiovascular Specialists
- National Clinical Research-Richmond, Inc
- Selma Medical Associates
- Larry D. Stonesifer, MD, Inc PS
- Seattle Women's
- Rowan Research Inc.
- MultiCare Research Institute
- Universal Research Group
- Wenatchee Valley Hospital & Clinics
- Cardiology Associates of Bellin Health
- Prevea Clinic, Inc
- Clinical Investigation Specialists, Inc.
- Meriter hospital Inc., DBA: UnityPoint Health-Meriter Heart
- Marshfield Clinic
- Aspirus Research Institute
- Coffs Harbour Health Campus
- Gosford Hospital, Cardiology Clinical Trials
- Liverpool Hospital
- Illawarra Shoalhaven Local Health District, Clinical Trial and Research Unit
- Wollongong Hospital
- Core Research Group
- Princess Alexandra Hospital, Cardiology Research Department
- Royal Brisbane and Women's Hospital, Endocrinology Department
- HeartCare Partners Clinical Research Unit
- AusTrials Pty Ltd
- Gold Coast Hospital, Cardiovascular Research Centre
- New Royal Adelaide Hospital, Cardiology Department
- Adelaide Medical Research
- Lyell McEwin Hospital, Department of Cardiology
- Heart and Vascular Institute
- The Queen Elizabeth Hospital
- Ballarat Health Services
- Geelong Cardiology Research Unit, Barwon Health
- Austin Health - Heidelberg Repatriation Hospital, Department of Medicine, Boronia Centre
- Avenue Cardiovascular Centre
- Joondalup Cardiovascular Trials Foundation Inc
- Fiona Stanley Hospital, Cardiology Research Department,CDO11
- South Australian Medical Research Inst, Centre for Clinical Research
- The Partners Clinical Research Centre
- LMC Clinical Research Inc. (Calgary)
- Gordon and Leslie Diamond Health Care Centre
- Nova Scotia Health Authority /QEII Health Sciences Centre
- LMC Diabetes & Endocrinology - Brampton
- McMaster University
- JBN Medical Diagnostic Services Inc.
- Aviva Clinical Trial Group In.
- Cambridge Cardiac Care Centre
- Joanne F. Liutkus Medicine Professional Corp.
- Saul Vizel Professional Medicine Corporation, Vizel Cardiac Research
- LMC Diabetes & Endocrinology (Etobicoke)
- Wharton Medical Clinic Clinical Trials Group Inc.
- Saint Josephs Health Care London
- LMC Diabetes & Endocrinoly
- New Market Cardiology Research Group
- Dr. Michael Heffernan
- LMC Clinical Research Inc. (Oakville)
- Dr. Cha
- University of Ottawa Heart Institute
- Kawartha Cardiology Clinical Trials
- Dr. Dinkar Shukla Professional Medicine Corporation
- Dr Roger Labonte Professional Medicine Corp
- LMC Diabetes & Endocrinology (Thornhill)
- JJ DIG Research Ltd.
- Keele Medical Place
- LMC Clinical Research Inc. (Bayview)
- St Michael's Hospital Health Centre
- ViaCar Recherche Clinique
- Q&T Research Outaouais Inc.
- ViaCar Recherche Clinique Inc.
- Manna Research Inc
- Clinique Sante Cardio MC
- Universitaire de Cardiologie et de Pneumologie de Quebec
- Centre hospitalier régional de Lanaudière
- Recherche Clinique London
- CardioVasc HR, Inc.
- ViaCar Recherche Clinique Inc.
- LMC Clinical Research Inc. (Montreal)
- Biomedica Research Group
- Sociedad Medica Cardiologica El Llano
- Hospital Regional Concepcion
- Cardiocob
- Servicios Medicos Godoy Ltda.
- Ccbr Cecim
- Centro Investigacion Clinica del Sur
- CECMI Ltda.
- ICLE
- Private Medical Practice
- IMED Clin Trials
- Cardiolink ClinTrials S.C.
- Centro de Estudios Clinicos y Especialidades Medicas S.C.
- Hospital de Angeles Xalapa
- Fundacion Cardiovascular de Aguascalientes
- Hospital Cardiologica Aguascalientes
- Mentrials S.A.de C.V.
- North Shore Hospital-Cardiology Research
- Middlemore Hospital
- North Shore Hospital - Diabetes Clinic
- Christchurch Hospital, Lipids
- Christchurch Hospital, Cardiology Research
- Dunedin Hospital
- Taranaki Base Hospital
- Hutt Hospital, Cardiology Dept
- Auckland City Hospital
- Hawkes Bay Regional Hospital
- Nelson Hospital, Cardiology Department
- Lakeland Clinical Trials, Rotorua
- Tauranga Hospital
- Indywidualna Specjalistyczna Praktyka Lekarska
- NZOZ "Eskulap"
- Podlaski Osrodek Kardiologii Janusz Korecki
- Centrum Medyczne KERmed
- 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
- Nzoz "Mada-Med"
- DIABET Centrum Medyczne s. c.
- ISPL w Dziedzinie Kardiologii lek.med. Krzysztof Cymerman
- NZOZ SCBK ProCordis
- Gabinet Kardiologiczno-Internistyczny
- Praktyka Lekarska dr n. med. Marek Bronisz
- Piotr Mader Diabetic Clinic NZOZ PD-I
- NZOZ Eskulap SC
- Ewa Mirek-Bryniarska Specjalistyczna Praktyka Lekarska
- LANDA' Specjalistyczne Gabinety Lekarskie
- Medyczne Centrum Diabetologiczno Endokrynologiczno
- Nzoz Cardiamed
- "CenterMed Lublin" Sp. z o.o.
- Indywidualna Praktyka Lekarska
- Zechowicz MEDEUSZ-PLUS
- Praktyka Lekarska Ewa Krzyzagorska
- NZOZ NEURO-KARD "Ilkowski i Partnerzy"
- Specjalistyczna Przychodnia Lekarska MEDIKARD (SPL Medikard)
- Specjalistyczny Gabinet Lekarski
- Lecznice Citomed Sp. z o.o.
- Praktyka Lekarska Pawlowicz Lidia
- Centrum Medyczne AMED
- Centrum Badawcze Wspolczesnej Terapii
- SNZOZ Fundacji PROCLINICA
- Centrum Zdrowia Wierzchoslawice
- Regionalna Poradnia Diabetologiczna
- Specjalistyczne Gabinety Lekarskie "Medicor PLUS"
- NZOZ ALL-MED Centrum Medyczne
- SP ZOZ w Lecznej
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Lorcaserin hydrochloride (HCL)10 mg
Placebo
APD356 10 mg twice daily
Placebo twice daily