POMC, PCSK1, and LEPR Deficiency (Adults and Pediatric Patients Aged 6 Years and Older) The safety of IMCIVREE was evaluated in two 52-week, open-label clinical trials of 27 patients aged 6 years and older with obesity due to POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPRgenes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (Trial 3 and Trial 4) [see Clinical Studies (14.3)]
In all three trials, severe hypoglycemia was significantly more likely in randomly assigned participants to the intensive glycemic control arm
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however, the incidence of acute gallbladder disease was greater in Wegovy patients than in placebo patients, even after accounting for the degree of weight loss
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