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What they found: Favorable safety profile , no serious adverse events at doses up to 100 g/kg Preliminary efficacy signals positive The program stopped before Phase 3 for unknown commercial reasons (the program passed through several sponsor rotations and no one ultimately carried it through) Why it matters: These are the only published clinical data in humans that we have
Landmark Achievement: CagriSema has produced mean weight loss exceeding 20% in Phase 3 trials, approaching the efficacy of bariatric surgery without invasive procedures
The exact terms of the FDA action would determine the boundaries
Patients with severe, longstanding deficiency typically require longer recovery periods, with haematological improvement occurring over weeks and neurological recovery potentially taking months
2 , e1600200 (2016)
