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FDA staff found inadequate characterisation, no evidence supporting insomnia effectiveness and no clinical safety data

Efficacy and safety of once-weekly cagrilintide for weight management: a randomised, placebo and active-controlled, dose-finding phase 2 trial Summary: This Phase 2 dose-finding trial investigated the efficacy and safety of cagrilintide monotherapy for weight management

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Clinical trial results Phase 2 trial data published in the New England Journal of Medicine showed that participants receiving the highest dose of retatrutide (12mg weekly) achieved 24.2% body weight reduction over 48 weeks