drugset / Trial / NCT05692492
A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this research is to evaluate the efficacy and the safety of two doses of ZSP1601 for 48 weeks versus placebo in adult NASH patients.
Timeline
- Start
- 2023-06-03
- Primary completion
- 2026-06-16
- Completion
- 2026-12-16
Outcome
Met primary endpoint
release “ZSP1601片IIb期临床试验顶线数据初步分析结果积极，有力支持继续开展III期临床试验。” raynovent.com ↗
release “结果显示，两个剂量组主要疗效终点应答率均显著优于安慰剂组。” raynovent.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ZSP1601 | Unknown | 50 mg | — |
| Subject | ZSP1601 | Unknown | 100 mg | — |