A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD

Summary

This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.

Timeline

Start

2019-03-29

Primary completion

2020-08-03

Completion

2020-08-10

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry Placebo vs PXL770 250 mg BID; p = 0.0842; Mean Difference (Final Values) -13.14 (95% CI -28.06 to 1.78); ANCOVA reads as mixed primary results NCT03763877 ↗

registry Placebo vs PXL770 500 mg QD; p = 0.0184; Mean Difference (Final Values) -17.31 (95% CI -31.63 to -2.99); ANCOVA reads as mixed primary results NCT03763877 ↗

registry Placebo vs PXL770 500 mg QD; p = 0.0387; Location Shift -18.72 (95% CI -31.95 to -1.58); Wilcoxon (Mann-Whitney) reads as mixed primary results NCT03763877 ↗

release “After successfully completing a Phase 2a proof-of-concept trial for the treatment of NASH, which met its primary endpoint and study objectives, for PXL770” reads as met primary endpoint sumitomo-pharma.com ↗

Publications

• Cusi K, Alkhouri N, Harrison SA, Fouqueray P, Moller DE, Hallakou-Bozec S, Bolze S, Grouin JM, Jeannin Megnien S, Dubourg J, Ratziu V. Efficacy and safety of PXL770, a direct AMP kinase activator, for the treatment of non-alcoholic fatty liver disease (STAMP-NAFLD): a randomised, double-blind, placebo-controlled, phase 2a study. Lancet Gastroenterol Hepatol. 2021 Nov;6(11):889-902. doi: 10.1016/S2468-1253(21)00300-9. Epub 2021 Sep 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PXL770	Unknown	250 mg	Oral
Subject	PXL770	Unknown	500 mg	Oral

Indications