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Phase 4 Completed N=12,000 Randomized Double-blind Treatment

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

Cardiovascular Disease · High Cardiovascular Risk · Obesity · Overweight
Source: ClinicalTrials.gov NCT02019264 ↗
Enrolled (actual)
12,000
Serious AEs
33.3%
Results posted
Jul 2019
Primary outcomePrimary: Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis — NA; NA days — p=0.0001
◆ Published Evidence
Highly cited
263citations · ~33 / year
Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients.
The New England journal of medicine · 2018 · Open access · Likely link

Summary

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.

Linked Publications (4)

  • Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients.
    The New England journal of medicine · 2018 · 263 citations · Open access · Likely link
  • Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial.
    Lancet (London, England) · 2018 · 95 citations · Open access · Likely link
  • Lorcaserin and Renal Outcomes in Obese and Overweight Patients in the CAMELLIA-TIMI 61 Trial.
    Circulation · 2019 · 35 citations · Likely link
  • 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.
    American heart journal · 2018 · 15 citations · Likely link

Outcome Measures

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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