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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 (CAMELLIA-TIMI 61)

Trial Profile

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 (CAMELLIA-TIMI 61)

Status: Completed
Phase of Trial: Phase III/IV

Latest Information Update: 17 Jul 2019

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At a glance

  • Drugs Lorcaserin (Primary)
  • Indications Obesity
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms CAMELLIA-TIMI; CAMELLIA-TIMI 61
  • Sponsors Eisai Inc
  • Most Recent Events

    • 18 Mar 2019 Results of a substudy (n=4318) assessing the persistence of valvulopathy measures, were presented at the 68th Annual Scientific Session of the American College of Cardiology.
    • 25 Feb 2019 According to an Eisai Inc media release, the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) to potentially update the label for BELVIQ (lorcaserin HCl) CIV 10 mg twice-daily/BELVIQ XR (lorcaserin HCl) CIV once daily to include long-term efficacy and safety data from CAMELLIA-TIMI 61 study.
    • 11 Oct 2018 Results published in the Lancet.
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