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FLOW was the only trial listed with a primary kidney outcome, specifically designed to assess the effect of a GLP-1 receptor agonist on major kidney events
This reduced activity, combined with a potentially slower metabolism that can occur with persistent nutrient deficiencies, could indirectly contribute to weight gain over time
In its Complete Response Letter (CRL), the regulator highlighted specific CMC issues that must be satisfactorily resolved before the application can be approved
However, further research is needed to determine whether it would have the same effects in individuals with hypothyroidism alone
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