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Trial of CS060380 Tablets for Non-alcoholic Steatohepatitis (NASH)

NCT07198386 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-13

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if CS060380 tablets works to treat non-alcoholic steatohepatitis(NASH) in adults.It will also learn about the safety of CS060380 tablets.The main questions it aims to answer are:

* After 12 weeks of administration, what was the percentage change in fat content evaluated by MRI-PDFF compared to the baseline？
* What medical problems do participants have when taking CS060380 tablets? Researchers will compare CS060380 tablets to a placebo (a look-alike substance that contains no drug) to see if CS060380 tablets works to treat NASH.

Participants will:

* Take CS060380 tablets or a placebo every day for 12 weeks
* Visit the clinic for checkups and tests at the frequency required by the protocol
* Keep a diary of their symptoms and the number of tablets taken

Conditions

  • NASH

Interventions

DRUG

CS060380

Oral QD

DRUG

Placebo

Oral QD

Sponsors & Collaborators

  • Cascade Pharmaceuticals, Inc

    lead OTHER

Principal Investigators

  • Junping Shi, MD · The Affiliated Hospital of Hangzhou Normal University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-07-24
Completion
2026-11-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07198386 on ClinicalTrials.gov