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In phase 3 adult clinical trials, most notably the SURMOUNT-1 study, tirzepatide produced significant and sustained reductions in body weight and metabolic parameters

407 In the early and middle stages of cardiovascular diseases such as heart failure, myocardial energy metabolism remains relatively normal, with little or slight increase in fatty acid utilization

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Conferring with FDA subject matter experts on facility layout and quality system design as part of the pilot program may remove or mitigate certain downstream regulatory inspection issues, such as reducing the chance of receiving a Complete Response Letter for manufacturing issues in response to a future marketing application, especially if the facility deploys new technological advancements