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A Phase 2a, Randomized, Double Blind (Sponsor-open), Placebo Controlled, Parallel Group Study To Assess The Pharmacodynamics, Safety And Tolerability Of Pf-05221304 And Pf-06865571 Co-administered For 6 Weeks In Adults With Non-alcoholic Fatty Liver Disease (Nafld)

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Trial Profile

A Phase 2a, Randomized, Double Blind (Sponsor-open), Placebo Controlled, Parallel Group Study To Assess The Pharmacodynamics, Safety And Tolerability Of Pf-05221304 And Pf-06865571 Co-administered For 6 Weeks In Adults With Non-alcoholic Fatty Liver Disease (Nafld)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 30 May 2022

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At a glance

  • Drugs Clesacostat (Primary) ; Ervogastat (Primary)
  • Indications Non-alcoholic fatty liver disease; Non-alcoholic steatohepatitis
  • Focus Therapeutic Use
  • Sponsors Pfizer

Most Recent Events

  • 26 May 2022 According to a Pfizer media release, based on the results from the study and nonclinical studies, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation tocombination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571)and clesacostat (PF-05221304).
  • 01 Oct 2021 Results of two studies (NCT03248882 & NCT03776175) assessing the effects of PF-05221304 (15 mg twice daily (BID)) co-administered with a DGAT2 inhibitor, PF-06865571 (300 mg BID), versus placebo after 6 weeks of treatment, published in the Nature Medicine.
  • 29 Aug 2020 Results testing whether coadministration of PF-05221304 and PF-06865571 leads to increased clinical efficacy in the treatment of NASH and mitigation of ACCi-induced TG elevations, presented at The International Liver Congress 2020

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