Actively Recruiting
Trial of CS060380 Tablets for Non-alcoholic Steatohepatitis (NASH)
Led by Cascade Pharmaceuticals, Inc · Updated on 2026-03-13
120
Participants Needed
8
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Trial of CS060380 Tablets for Non-alcoholic Steatohepatitis (NASH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 to 70 (including boundary values)
- Liver biopsy within 6 months showing NASH with NAS score 64 and fibrosis stage F1-F3, or MRI confirming liver fat 65 10% within 3 months
- Participants of childbearing potential and their partners agree to effective contraception from screening to 3 months after last dose
- Stable ALT and AST levels before randomization with specific criteria if elevated
- Avoid strenuous exercise 24 hours before visits or blood draws
- Signed informed consent form and ability to complete study as required
You will not qualify if you...
- Presence of other significant liver or biliary diseases not caused by NASH, including hepatitis B or untreated hepatitis C, drug-induced liver injury, alcoholic liver disease, Wilson's disease, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis
- History of liver cirrhosis or primary liver cancer with AFP > 50 bcg/L
- Allergies to study drug ingredients
- Surgical procedures interfering with treatment such as weight loss surgery or liver transplant
- History of malignancy within past 5 years
- Contraindications to MRI
- History of drug or substance abuse within 2 years
- History of heavy drinking for more than 3 consecutive months within 1 year
- Significant recent weight changes or blood donation
- Serious cardiovascular diseases or recent related surgeries
- Uncontrolled diabetes, intestinal diseases affecting drug absorption, thyroid or pituitary disorders
- Serious circulatory, respiratory, urinary, hematological, immune, psychiatric, neurological, or renal diseases deemed unsuitable
- Uncontrolled hypertension
- Abnormal ECG QTcF intervals
- Positive HIV or syphilis antibodies
- Pregnant or lactating women
- Abnormal lab results including low platelets, high bilirubin, elevated liver enzymes, reduced kidney function, thyroid abnormalities, or high cardiac troponin
- Recent use or unstable doses of certain medications including SGLT2 inhibitors, PCSK9 inhibitors, vitamin E, pioglitazone, GLP-1 receptor agonists, various antidiabetic or lipid-lowering drugs
- Participation in other clinical trials within specified time frames
- Recent use of drugs causing liver toxicity or hepatoprotective drugs not allowed by protocol
- Recent anticoagulant use
- Use of certain enzyme inhibitors or inducers affecting drug metabolism
- Other conditions deemed unsuitable by researchers
AI-Screening
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Trial Site Locations
Total: 8 locations
1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Not Yet Recruiting
2
Xiamen Hospital of T.C,M.
Xiamen, Fujian, China
Actively Recruiting
3
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China
Actively Recruiting
4
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
5
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
6
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
7
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China, 311121
Actively Recruiting
8
Ruian People's Hosptial
Wenzhou, Zhejiang, China
Actively Recruiting
Research Team
R
Rong Deng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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