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
Source: ClinicalTrials.gov NCT02019264 ↗Summary
Linked Publications (4)
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Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients.
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Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial.
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Lorcaserin and Renal Outcomes in Obese and Overweight Patients in the CAMELLIA-TIMI 61 Trial.
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Design and rationale for the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients-Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis |
NA; NA | 0.0001 sig |
| PRIMARY Time From Randomization to First Occurrence of MACE+ |
NA; NA | 0.5464 |
| SECONDARY Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Participants With Prediabetes at Baseline |
NA; NA | 0.0380 sig |
| SECONDARY Time From Randomization to First Occurrence of the Individual Components of MACE+ |
NA; NA; NA; NA; NA; NA | 0.0001 sig |
| SECONDARY Time From Randomization to Event of All-cause Mortality |
NA; NA | 0.4212 |
| SECONDARY Time From Randomization to Conversion to Normal Glucose Homeostasis in Participants With Prediabetes at Baseline |
NA; NA | 0.1810 |
| SECONDARY Time From Randomization to Conversion to T2DM for Participants Without Any Type of Diabetes at Baseline |
NA; NA | 0.0116 sig |
| SECONDARY Change From Baseline in HbA1c at Month 6 in Participants With T2DM at Baseline |
6.99; 7.01; 0.06; -0.33 | <0.0001 sig |
| SECONDARY Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Participants |
NA; NA | 0.0054 sig |
| SECONDARY Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With Prediabetes at Baseline |
NA; NA | 0.3661 |
| SECONDARY Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With T2DM at Baseline |
NA; NA | 0.0082 sig |
| SECONDARY Time From Randomization to Event of Improvement in Renal Function in Participants With T2DM at Baseline |
NA; NA | 0.0297 sig |
| SECONDARY Percentage of Participants Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes |
1.4; 2.1; 1.5; 1.8 | 0.5015 |
| SECONDARY Percentage of Participants With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy |
2.1; 3.5; 1.7; 2.1 | 0.7249 |
| SECONDARY Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure |
26.4354; 26.2029; -0.6418; -0.8223 | 0.2976 |
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 ( = 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
Data sourced from ClinicalTrials.gov (NCT02019264) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.