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the remaining two protocols for its Phase III development programme for cetilistat under the Special Protocol Assessment (“SPA”) procedure and recommended that Alizyme open a separate diabetes IND.
Cetilistat is Alizyme's metabolic product under development for the treatment of obesity and associated comorbidities, including type 2 diabetes. It is a gastrointestinal lipase inhibitor that blocks fat digestion and absorption, leading to reduced energy intake, and thus weight loss.
Following successful end of Phase II discussions, FDA approved Alizyme’s outline plan for the Phase III clinical development programme of cetilistat... [PDF] Alizyme's Press Release -