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

NCT07198386 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CS060380-NASH-CN-IIa-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 8

Brief 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

Outcome Measures

Primary Outcomes (1)

• MRI-PDFF

  To assess the changes in liver steatosis through magnetic resonance imaging (MRI) proton density fat fraction (PDFF) from baseline to Week 12.

  D85

Secondary Outcomes (22)

• AE, SAE, Vital signs, Physical examination, 12-ECG, Thyroid function, laboratory tests.

  Up to 12 weeks

• ALT, AST, GGT, TC, LDL-C, HDL-C, TG, ApoB, Lp(a), The ApoB/ApoA ratio.

  Up to 12 weeks

• Hypersensitive C-reactive protein

  Up to 12 weeks

• MRI-PDFF relative baseline decrease percentage

  Baseline to Day 85

• ALT relative to baseline decrease ratio

  Up to 12 weeks

Other Outcomes (1)

• Use iLivTouch to evaluate the changes of Liver stiffness measurement value (LSM), LIID and Ultrasonic attenuation parameter (UAP) compared to the baseline.

  Day 1, day 85.

Study Arms (6)

Part A: Group A of 0.25 mg CS060380

EXPERIMENTAL

Take five tablets of 0.05mg CS060380 daily for 12 weeks.

Drug: CS060380

Part A: Group B of 0.5 mg CS060380

EXPERIMENTAL

Take one tablet of 0.5mg CS060380 and four tablets of placebo daily for 12 weeks.

Drug: CS060380; Drug: Placebo

Part A: Placebo

PLACEBO COMPARATOR

Take five tablets of placebo daily for 12 weeks.

Drug: Placebo

Part B: Group C of 1 mg CS060380

EXPERIMENTAL

Take two tablets of 0.5mg CS060380 and two tablets of placebo daily for 12 weeks.

Drug: CS060380; Drug: Placebo

Part B: Group D of 2 mg CS060380

EXPERIMENTAL

Take four tablets of 0.5mg CS060380 daily for 12 weeks.

Drug: CS060380

Part B: Placebo

PLACEBO COMPARATOR

Take four tablets of placebo daily for 12 weeks.

Drug: Placebo

Interventions

CS060380 DRUG

Oral QD

Part A: Group A of 0.25 mg CS060380; Part A: Group B of 0.5 mg CS060380; Part B: Group C of 1 mg CS060380; Part B: Group D of 2 mg CS060380

Placebo DRUG

Oral QD

Part A: Group B of 0.5 mg CS060380; Part A: Placebo; Part B: Group C of 1 mg CS060380; Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Cascade Pharmaceuticals, Inc: lead

Study Sites (8)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

NOT YET RECRUITING

Xiamen Hospital of T.C,M.

Xiamen, Fujian, China

RECRUITING

The Fifth People's Hospital of Suzhou

Suzhou, Jiangsu, China

RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, 311121, China

RECRUITING

Ruian People's Hosptial

Wenzhou, Zhejiang, China

RECRUITING

Study Officials

• Junping Shi, MD

  The Affiliated Hospital of Hangzhou Normal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Deng

CONTACT

15618699506; dengrong@cascadepharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 30, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

CN (8)