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

A Multi-center, Randomized, Double-blind, Dose-increasing, Placebo-controlled，Multi-dose, 28-day Continuous Administration Phase Ib/IIa Clinical Trial to Evaluate the Tolerability, Efficacy, and PK of ZSP1601 in Patients With Nonalcoholic Steatohepatitis

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04140123

Enrollment

Registered

2019-10-25

Start date

2020-06-23

Completion date

2021-08-03

Last updated

2021-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Steatohepatitis (NASH)

Brief 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).

Interventions

DRUGZSP1601

ZSP1601 tablets be taken orally for 28 days.

DRUGZSP1601 Placebo

Subjects will receive matching placebo of ZSP1601

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Subjects are required to meet the following criteria in order to be included in the trial: 1. Signature signed informed consent before the trial, and fully understood the content, process and possible adverse reactions. 2. Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study. 3. Subjects(including partners)have no gestation plans and must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product. 4. Male and female subjects aged 18-65 (including 18 and 65). 5. B ultrasound confirmed fatty liver. 6. NASH diagnosis or NASH phenotypic diagnosis. 7. Liver fat ≥10% at baseline (MRI-PDFF)

Exclusion criteria

* Eligible subjects must not meet any of the following

Design outcomes

Primary

Measure	Time frame	Description
Number and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE) following oral doses of ZSP1601 and placebo.	Initiation of study treatment (Day 1) up to 2 weeks post-treatment.	severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE)

Secondary

Measure	Time frame	Description
Rac of Cmax	Day1 and day 14	Rac of ZSP1601 Peak Plasma Concentration at steady state
MRI-PDFF	Baseline and Day 28.	liver fat content with Magnetic resonance imaging proton density fat fraction (MRI-PDFF)
TNF-α	Baseline and Day 28.	Tumor necrosis factor alpha level in serum
ALT	Baseline and Day 28.	serum Alanine Aminotransferase
AST	Baseline and Day 28.	serum Aspartate Aminotransferase
Cmax	Day1 and day 14	Maximum Contentration
t1/2z	Day1 and day 14	t1/2z is defined as the time to decline half of the drug concentration in plasma.
DF of ZSP1601 at steady status	Day1 and day 14	Multiple-dose plasma PK parameter: DF of ZSP1601 at steady status
AUClast（AUC0-t）	Baseline (0h) and day 14	AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
Rac of AUC	Day1 and day 14	RAC of ZSP1601 Area under the plasma concentration versus time curve at steady state
Tmax	Day1 and day 14	The time after dosing when Cmax occurs (Tmax)

Other

Measure	Time frame	Description
AUC(inf)	Day1 and day 14	Area under the curve extrapolated until time is infinity (AUCinf)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026