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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: NASH

In brief

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

Key facts

Study ID

NCT07198386

Run by

Cascade Pharmaceuticals, Inc

People needed

120

Starts

2025-09-30

Expected to finish

2026-11-30

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women aged 18 to 70 (including the boundary value).
• Liver biopsy results within 6 months prior to randomization were consistent with the pathological diagnosis of NASH, and the non-alcoholic fatty liver disease activity score (NAS) was ≥4 points, with at least 1 point each for inflammation and balloon changes, and the fibrosis stage of the Clinical Study Network for Non-alcoholic Steatohepatitis (NASH-CRN) in the United States was F1-F3; Or, the liver fat content is confirmed to be ≥ 10% based on the magnetic MRI-PDFF results of this hospital within the previous 3 months..
• Participants with fertility and their spouses or partners voluntarily took effective contraceptive measures from screening to within 3 months after the last administration. Among them, women of childbearing age include premenopausal women and women within two years after menopause, except those who have undergone hysterectomy or bilateral oophorectomy or have medically confirmed ovarian failure.
• Before randomization, there were stable ALT and AST results. If the ALT or AST value during the screening period was ≥ 1.5 × (ULN), it is necessary to have continuous 2 stable evidences before randomization (the two evaluations need to be spaced at least 2 weeks apart), and one of the following evidences must be met:
• Compared with the historical data within 2 weeks to 3 months before the screening process (if any, and the value ≤5×ULN), the ALT or AST value during the screening period needs to increase by ≤30% compared with the historical data.
• If there is no available historical data and the ALT or AST value during the screening period is greater than 1.5×ULN, the test should be repeated at least once every two weeks. The ALT or AST value after re-testing should increase by no more than 30% compared to the screening period.
• Avoid strenuous exercise at least 24 hours before each visit or blood draw.
• Sign the ICF before the experiment and be able to complete the research as required by the protocol.

You may not qualify if…

• The following liver diseases or past medical history were present at the time of screening:
• Patients with other clinically significant acute or chronic liver diseases or biliary tract diseases not caused by NASH, and the researchers determined that not suitable to participate in this study, Including but not limited to hepatitis B virus, Untreated hepatitis C virus, DILI, ALD, WD, AIH, PBC, PSC.
• Has a history of liver cirrhosis.
• Primary liver cancer. AFP > 50 μg/L.
• During screening, the following medical history was present:
• Study the history of allergies to drug ingredients and excipients.
• Surgical procedures that may interfere with treatment, including but not limited to weight loss surgery, liver transplantation surgery, etc.
• Screen those who have a history of malignant tumors within the previous five years.
• Contraindications for any MRI scan.
• Screen for a history of drug or substance abuse within the previous two years.
• Screen for a history of heavy drinking for more than three consecutive months within one year prior to the screening.
• Weight change ≥ 5% in the first 3 months of randomization or ≥ 10% in the first 6 months of randomization.
• Individuals who have donated blood within the past 3 months prior to screening, and those who have lost a total of 400 mL or more due to blood donation or other reasons within the past 6 months.
• Merge with any of the following serious cardiovascular disease or surgical histories (including but not limited to):
• Unstable angina pectoris occurred within 3 months prior to randomization.
• Combined heart failure, NYHA ≥ Ⅲ
• Myocardial infarction, shock or life-threatening arrhythmia occurred within 6 months prior to randomization.
• Randomized coronary artery bypass grafting surgery or percutaneous coronary intervention within the first 6 months.
• The following concomitant diseases or conditions occur during the screening period:
• T1DM, uncontrolled T2DM (HbA1c > 9 % ), history of severe hypoglycemia.
• Intestinal diseases that affect the absorption of oral medications.
• There are thyroid diseases, including hyperthyroidism and hypothyroidism or pituitary disorders.
• Combined with serious diseases such as circulatory, respiratory, urinary, hematological, immune, psychiatric, neurological, and renal disorders, it has been determined by the researchers that it is not suitable to participate in this study.
• Uncontrolled hypertension was present during screening: systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg even under regular medication control.
• When screening QTcF >450 ms (for males) or >470 ms (Female).

Where it is running

• Zhongshan Hospital Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• The Affiliated Hospital of Hangzhou Normal University — Hangzhou, Zhejiang, China (enrolling)
• Ruian People's Hosptial — Wenzhou, Zhejiang, China (enrolling)
• Xiamen Hospital of T.C,M. — Xiamen, Fujian, China (enrolling)
• The Fifth People's Hospital of Suzhou — Suzhou, Jiangsu, China (enrolling)
• Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China

Full record on ClinicalTrials.gov

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