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Safety signals in specific populations, insufficient efficacy in certain endpoints, or manufacturing challenges could all slow progress
However, rapid weight loss with semaglutide can lead to loss of lean muscle mass

Many of the letters cite claims implying that compounded GLP-1 drugs have been FDA approved, evaluated for safety and effectiveness, or are the same as FDA-approved reference products

We conducted a thorough search of both published and gray literature to ensure the inclusion of all relevant clinical trials on this topic
Therefore, regulatory guidance specifies that this major cardiovascular risk equivalent requires all new drugs and biologics for glycemic control to demonstrate cardiovascular safety
