NCT07198386

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

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of CS060380 Tablets in Patients With Non-alcoholic Steatohepatitis (NASH).

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Cascade Pharmaceuticals, Inc · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase IIa clinical trial to evaluate CS060380 tablets in patients with non-alcoholic steatohepatitis (NASH). This study consists of two parts, Part A and Part B. The plan is to conduct the Part A study first. Subjects who meet the inclusion criteria will be randomly assigned in a 1:1:1 ratio to group A at 0.25mg, study group B at 0.5mg, and placebo group, with a planned inclusion of 20 subjects in each group. The sponsor will base on the safety and tolerability results obtained in Part A to decide whether to proceed to Part B.Subjects of Part B who meet the inclusion criteria will be randomly assigned in a 1:1:1 ratio to group C at 1mg, study group D at 2mg, and placebo group, with a planned inclusion of 20 subjects in each group. Part A and Part B will take the investigational product on an empty stomach once a day at a fixed time as much as possible for 12 consecutive weeks.

Conditions

• NASH

Interventions

Type	Name	Description
DRUG	CS060380	Oral QD
DRUG	Placebo	Oral QD

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-07-24
• Completion: 2026-11-30
• First posted: 2025-09-30
• Last updated: 2026-03-13

Locations

8 sites across 1 country: China

Regulatory

• FDA-regulated drug study