Assessing the Cardiovascular Safety of Novel Diabetes and Obesity Medications – Implications for Early Phase Development

Assessing the Cardiovascular Safety of Novel Diabetes and Obesity Medications – Implications for Early Phase Development

  • The FDA requires that new glucose-lowering and anti-obesity agents demonstrate cardiovascular safety.
  • While many approved diabetes drugs and new obesity drugs have been shown to improve cardiometabolic risk factors, they have not been rigorously characterized in their cardiovascular profiles.
  • The cardiovascular effects of novel compounds can be rigorously assessed in early phase development using advanced imaging and circulating and/or functional methodologies to inform development decisions based on early signs of cardiovascular risk or benefit.
  • Robust characterization of the cardiovascular effects of a novel therapy during early development is a safe and cost-effective way to identify potential cardiovascular risk prior to initiating large, expensive phase 3 or 4 cardiovascular outcome trials.

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