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)
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ClinicalTrials.gov Identifier: NCT02019264
Recruitment Status :
Active, not recruiting
First Posted : December 24, 2013
Last Update Posted : November 6, 2017
Thrombolysis In Myocardial Infarction (TIMI) Academic Research Organization
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.
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
Actual Study Start Date :
Estimated Primary Completion Date :
Estimated Study Completion Date :
Resource links provided by the National Library of Medicine
Time from randomization to first occurrence of Major Adverse Cardiovascular Events (MACE) [ Time Frame: Up to 5 years ]
MACE events include: myocardial infarction, stroke and cardiovascular (CV) death
Time from randomization to conversion to type 2 diabetes mellitus (T2DM) for subjects without any type of diabetes at Baseline [ Time Frame: Baseline, and specified timepoints up to 5 years ]
Time from randomization to first occurrence of MACE+ [ Time Frame: Up to 5 years ]
MACE+ events include: myocardial infarction, stroke, CV death, and hospitalization due to unstable angina, heart failure, or any coronary revascularization
Secondary Outcome Measures :
Time from randomization to event of each component of MACE+ [ Time Frame: Up to 5 years ]
Time from randomization to event of all-cause mortality [ Time Frame: Up to 5 years ]
Time from randomization to event of new onset renal impairment or worsening existing renal impairment in subjects with T2DM at Baseline [ Time Frame: Up to 5 years ]
New onset renal impairment or worsening existing renal impairment include the first occurrence of microalbuminuria, macroalbuminuria, worsening of albuminuria, newly developed CKD, or worsening of CKD, doubling of serum creatinine, or any of the following: ESRD, renal transplant, and renal death.
Time from randomization to event of improvement in renal function [ Time Frame: Up to 5 years ]
Change from Baseline in HbA[1c] at 6 months in subjects with T2DM at Baseline [ Time Frame: Baseline and 6 months ]
The proportion of subjects who meet FDA-defined valvulopathy in echocardiographically determined heart valve changes [ Time Frame: Baseline and 1 year ]
Comparison between lorcaserin HCl and placebo will be made at 1 year.
The percent change from Baseline in echocardiographically-determined pulmonary arterial systolic pressure [ Time Frame: Baseline and 1 year ]
Comparison between lorcaserin HCl and placebo will be made at 1 year.
Time to conversion to normal glucose homeostasis [ Time Frame: Baseline and 1 year ]
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Ages Eligible for Study:
40 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
BMI greater than or equal to 27 kg/m^2
Subjects able and willing to comply with a reduced-calorie diet and an increased physical activity program
Age greater than or equal 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)
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:
Hypertension, or currently receiving therapy for documented hypertension
Dyslipidemia, or currently taking prescription lipid-lowering therapy for documented dyslipidemia
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
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.
Moderate or greater symptoms of congestive cardiac failure (New York Heart Association [NYHA] class III or IV)
Known left ventricular (LV) ejection fraction less than 20%
Moderate or greater symptoms of pulmonary hypertension (PH)
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)
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 prior to Screening including, but not limited to: cyproheptadine, amoxapine, TCAs, mirtazapine, 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