Trial of CS060380 Tablets for Non-alcoholic Steatohepatitis (NASH)
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
Timeline
- Start
- 2025-09-30
- Primary completion
- 2026-07-24
- Completion
- 2026-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CS060380 | Unknown | 0.25 mg | Oral |
| Subject | CS060380 | Unknown | 0.5 mg | Oral |
| Subject | CS060380 | Unknown | 1 mg | Oral |
| Subject | CS060380 | Unknown | 2 mg | Oral |