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



Status:Completed
Conditions:Obesity Weight Loss, Obesity Weight Loss, Peripheral Vascular Disease, Diabetes, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:40 - Any
Updated:9/8/2018
Start Date:January 24, 2014
End Date:May 14, 2018

Use our guide to learn which trials are right for you!

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

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.

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
We found this trial at
431
sites
6535 North Charles Street
Baltimore, Maryland 21204
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
900 East 30th Street
Austin, Texas 78705
512-480-9660
?
mi
from
Austin, TX
Click here to add this to my saved trials
8600 Old Georgetown Road
Bethesda, Maryland 20814
301-896-3100
Suburban Hospital Suburban Hospital is a community-based, not-for-profit hospital serving Montgomery County and the surrounding...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
1045 North 30th Street
Billings, Montana 59101
406-255-8470
?
mi
from
Billings, MT
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
4085 University Blvd S # 1
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
?
mi
from
Longview, TX
Click here to add this to my saved trials
400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
8122 Datapoint Drive
San Antonio, Texas 78229
210-614-7483
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Sarasota, Florida 34232
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
3212 Cove Bend Drive
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
1000 W Carson St
Torrance, California 90502
?
mi
from
Torrance, CA
Click here to add this to my saved trials
6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
1365 Washington Avenue
Albany, New York 12206
?
mi
from
Albany, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87102
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Alexander City, Alabama
?
mi
from
Alexander City, AL
Click here to add this to my saved trials
Alexandria, Virginia 22304
?
mi
from
Alexandria, VA
Click here to add this to my saved trials
1999 Marcus Avenue
Alhambra, California 91801
?
mi
from
Alhambra, CA
Click here to add this to my saved trials
Alpena, Michigan 49707
?
mi
from
Alpena, MI
Click here to add this to my saved trials
Altoona, Pennsylvania 16602
?
mi
from
Altoona, PA
Click here to add this to my saved trials
Altoona, Pennsylvania 16602
?
mi
from
Altoona, PA
Click here to add this to my saved trials
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
Anchorage, Alaska 99508
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Anderson, Indiana 46011
?
mi
from
Anderson, IN
Click here to add this to my saved trials
Annapolis, Maryland 21401
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
2800 Shirlington Road
Arlington, Virginia 22201
?
mi
from
Arlington, VA
Click here to add this to my saved trials
Arlington Heights, Illinois 60005
?
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
Athens, Alabama 35811
?
mi
from
Athens, AL
Click here to add this to my saved trials
5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
(678) 843-7001
Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1800 Howell Mill Road
Atlanta, Georgia 30318
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
593 Center Street
Auburn, Maine 04210
?
mi
from
Auburn, ME
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
2845 Northeast 199th Street
Aventura, Florida 33180
?
mi
from
Aventura, FL
Click here to add this to my saved trials
8607 East US Highway 36
Avon, Indiana 46123
?
mi
from
Avon, IN
Click here to add this to my saved trials
Bakersfield, California 93308
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Baltimore, Maryland 21236
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21218
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21218
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21237
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21228
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
9105 Franklin Square Drive
Baltimore, Maryland 21237
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bangor, Maine 04401
?
mi
from
Bangor, ME
Click here to add this to my saved trials
1 Northeast Drive
Bangor, Maine 04401
?
mi
from
Bangor, ME
Click here to add this to my saved trials
13205 Isle Drive
Baxter, Minnesota 56425
?
mi
from
Baxter, MN
Click here to add this to my saved trials
?
mi
from
Beachwood, OH
Click here to add this to my saved trials
Beaver, Pennsylvania 15009
?
mi
from
Beaver, PA
Click here to add this to my saved trials
414 North Camden Drive
Beverly Hills, California 90210
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
?
mi
from
Biddeford, ME
Click here to add this to my saved trials
Billings, Montana 59102
?
mi
from
Billings, MT
Click here to add this to my saved trials
Binghamton, New York 13901
?
mi
from
Binghamton, NY
Click here to add this to my saved trials
Birmingham, Alabama 35294
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Bloomington, Indiana 47403
?
mi
from
Bloomington, IN
Click here to add this to my saved trials
50 Staniford Street
Boston, Massachusetts 02114
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boynton Beach, Florida 33437
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Boynton Beach, Florida 33427
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
Bradenton, Florida
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
3632 Queen Palm Drive
Bradenton, Florida 34209
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Brandon, Florida 33511
?
mi
from
Brandon, FL
Click here to add this to my saved trials
Bridgeport, Connecticut 06610
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
Bridgeport, Connecticut 06606
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
Bridgewater, New Jersey
?
mi
from
Bridgewater, NJ
Click here to add this to my saved trials
225 Jackson Street
Bridgewater, New Jersey 08807
?
mi
from
Bridgewater, NJ
Click here to add this to my saved trials
111 North Main Street
Bristol, Connecticut 06010
?
mi
from
Bristol, CT
Click here to add this to my saved trials
Bristol, Tennessee 37620
?
mi
from
Bristol, TN
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Brooksville, Florida 34601
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
Buffalo, New York 14215
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Burke, Virginia 22015
?
mi
from
Burke, VA
Click here to add this to my saved trials
Burlington, North Carolina 27215
?
mi
from
Burlington, NC
Click here to add this to my saved trials
Cadillac, Michigan 49601
?
mi
from
Cadillac, MI
Click here to add this to my saved trials
Camp Hill, Pennsylvania 17011
?
mi
from
Camp Hill, PA
Click here to add this to my saved trials
Canton, Ohio 44710
?
mi
from
Canton, OH
Click here to add this to my saved trials
Carmichael, California 95608
?
mi
from
Carmichael, CA
Click here to add this to my saved trials
Carrollton, Texas 75010
?
mi
from
Carrollton, TX
Click here to add this to my saved trials
2000 Regency Parkway
Cary, North Carolina 27511
?
mi
from
Cary, NC
Click here to add this to my saved trials
335 North Alma School Road
Chandler, Arizona 85224
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28209
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
6035 Shallowford Road
Chattanooga, Tennessee 37421
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
2205 McCallie Avenue
Chattanooga, Tennessee 37404
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chesterfield, Missouri 63017
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60607
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chula Vista, California 91910
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45236
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
455 Pinellas Street
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Colorado Springs, Colorado 80922
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Colorado Springs, Colorado 80909
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
2700 Grant Street
Concord, California 94520
?
mi
from
Concord, CA
Click here to add this to my saved trials
Conyers, Georgia 30094
?
mi
from
Conyers, GA
Click here to add this to my saved trials
801 Monterey Street
Coral Gables, Florida 33134
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Coral Springs, Florida 33065
?
mi
from
Coral Springs, FL
Click here to add this to my saved trials