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Key regulatory milestones: Phase 2 results published in NEJM (2023) Phase 3 TRIUMPH-4 topline results reported December 11, 2025 (28.7% mean weight loss at 12 mg / 68 weeks, approximately 71 lb at cohort starting weight); additional trials reading out 2026 (NCT05929066, NCT06070792) FDA approval window: still pending the full Phase 3 package and regulatory review Current non-trial access is research or grey-market, not an approved prescription pathway
[19] [20] These medications can occasionally mask or delay diagnosis of other gastrointestinal conditions
Clinical trials and post-marketing reports provide insights into how often these reactions occur: Clinical Trials: During clinical trials of semaglutide, a small percentage of participants reported skin reactions, including rashes
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