Tolerability, Efficacy, and PK of ZSP1601 in Patients With Non-Alcoholic Steatohepatitis (NASH)

Summary

Double-blind, randomized, placebo-controlled study to explore the safety, tolerability PK characteristics and early efficacy of ZSP1601 tablets in patients with non-alcoholic steatohepatitis (NASH).

Timeline

Start

2020-06-23

Primary completion

2021-08-03

Completion

2021-08-03

Outcome

Met primary endpoint

paper We conclude that ZSP1601 is well-tolerated and safe PMID 37828034 ↗

Publications

• Hu Y, Li H, Zhang H, Chen X, Chen J, Xu Z, You H, Dong R, Peng Y, Li J, Li X, Wu D, Zhang L, Cao D, Jin H, Qiu D, Yang A, Lou J, Zhu X, Niu J, Ding Y. ZSP1601, a novel pan-phosphodiesterase inhibitor for the treatment of NAFLD, A randomized, placebo-controlled phase Ib/IIa trial. Nat Commun. 2023 Oct 12;14(1):6409. doi: 10.1038/s41467-023-42162-0.

Drugs

Indications