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In June 2026, the agency sent its third wave of warning letters in about a year to telehealth companies marketing compounded semaglutide and tirzepatide, citing misleading claims and undisclosed compounding pharmacies

The optimal Phase III strategy is to demonstrate non-inferiority to tirzepatide at 72 weeks, then pursue superiority via a CVOT and/or MASH indication to unlock premium formulary access

According to the FDA prescribing information, nausea, diarrhea, and vomiting are among the most common side effects, with rates varying by dose

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