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No changes were made to the endpoints for the comparison of tirzepatide versus dulaglutide in the expanded population because we observed high concordance with SURPASS-CVOT estimates in the primary composite endpoint as well as mortality in the benchmarking study

CDER does not conduct its own testing

Clinical trials have demonstrated that individuals using semaglutide for weight management can lose an average of 15% to 20% of their body weight over 68 weeks

Data showed that following cessation of treatment a weight regain was observed at a rate of approximately 0.8kg/month with the average patient back to baseline by 18-20 months

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