Based on REDEFINE trial populations and the NDA submission terms, expected eligibility criteria are: BMI 30 , or BMI 27 with at least one weight-related condition such as hypertension, dyslipidemia, type 2 diabetes, or obstructive sleep apnea Adults 18 years or older Not pregnant or breastfeeding Contraindications will likely include: personal or family history of MTC or MEN 2 syndrome, prior serious allergic reaction to semaglutide or cagrilintide, and active pancreatitis
AMY, amylin analogue
the mechanism of action determines benefit duration
The applicant further opined that, although not explicitly stated, the paper presumably calculated the sample size based on the primary endpoint of stent removal, not to detect any clinical differences and, while Johnson et al
Ron DeSantis was on hand for the announcement and said, Florida continues to lead on economic opportunity