ZSP1601, a novel pan-phosphodiesterase inhibitor for the treatment of NAFLD, A randomized, placebo-controlled phase Ib/IIa trial

Yue Hu, Haijun Li, Hong Zhang, Xiaoxin Chen, Jinjun Chen, Zhongyuan Xu, Hong You, Ruihua Dong, Yun Peng, Jing Li, Xiaojiao Li, Dandan Wu, Lei Zhang, Di Cao, He Jin, Dongdong Qiu, Aruhan Yang, Jinfeng Lou, Xiaoxue Zhu (), Junqi Niu () and Yanhua Ding ()
Additional contact information
Yue Hu: First Hospital of Jilin University
Haijun Li: Guangdong Raynovent Biotech Co., Ltd
Hong Zhang: First Hospital of Jilin University
Xiaoxin Chen: Guangdong Raynovent Biotech Co., Ltd
Jinjun Chen: Nanfang Medical University
Zhongyuan Xu: Nanfang Medical University
Hong You: Capital Medical University
Ruihua Dong: Capital Medical University
Yun Peng: Guangdong Raynovent Biotech Co., Ltd
Jing Li: Guangdong Raynovent Biotech Co., Ltd
Xiaojiao Li: First Hospital of Jilin University
Dandan Wu: First Hospital of Jilin University
Lei Zhang: First Hospital of Jilin University
Di Cao: Capital Medical University
He Jin: Capital Medical University
Dongdong Qiu: First Hospital of Jilin University
Aruhan Yang: First Hospital of Jilin University
Jinfeng Lou: First Hospital of Jilin University
Xiaoxue Zhu: First Hospital of Jilin University
Junqi Niu: First Hospital of Jilin University
Yanhua Ding: First Hospital of Jilin University

Nature Communications, 2023, vol. 14, issue 1, 1-11

Abstract: Abstract Non-alcoholic fatty liver disease is a growing health burden with limited treatment options worldwide. Herein we report a randomized, double-blind, placebo-controlled, multiple-dose trial of a first-in-class pan-phosphodiesterase inhibitor ZSP1601 in 36 NAFLD patients (NCT04140123). There were three cohorts. Each cohort included twelve patients, nine of whom received ZSP1601 50 mg once daily, 50 mg twice daily, or 100 mg twice daily, and three of whom received matching placebos for 28 days. The primary outcomes were the safety and tolerability of ZSP1601. A total of 27 (27/36, 75%) patients experienced at least one treatment-emergent adverse event (TEAE). Most TEAEs were mild to moderate. There was no Serious Adverse Event. Diarrhea, transiently elevated creatinine and adaptive headache were frequently reported adverse drug reaction. We conclude that ZSP1601 is well-tolerated and safe, showing effective improvement in liver chemistries, liver fat content and fibrosis in patients with NAFLD.

Date: 2023
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DOI: 10.1038/s41467-023-42162-0

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