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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGXiamen Hospital of T.C,M.
Xiamen, Fujian, China
RECRUITINGThe Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China
RECRUITINGRuijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGXinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGZhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGThe Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
RECRUITINGRuian People's Hosptial
Wenzhou, Zhejiang, China
RECRUITINGMRI-PDFF
To assess the changes in liver steatosis through magnetic resonance imaging (MRI) proton density fat fraction (PDFF) from baseline to Week 12.
Time frame: D85
AE, SAE, Vital signs, Physical examination, 12-ECG, Thyroid function, laboratory tests.
Safety and Tolerability.
Time frame: Up to 12 weeks
ALT, AST, GGT, TC, LDL-C, HDL-C, TG, ApoB, Lp(a), The ApoB/ApoA ratio.
The percentage change in liver injury and lipid metabolic indicators compared to the baseline period.
Time frame: Up to 12 weeks
Hypersensitive C-reactive protein
The change of hypersensitive C-reactive protein from baseline.
Time frame: Up to 12 weeks
MRI-PDFF relative baseline decrease percentage
Percentage of participants with a relative decrease in fat content (%) assessed by MRI-PDFF of ≥30% compared to baseline.
Time frame: Baseline to Day 85
ALT relative to baseline decrease ratio
The proportion of participants whose ALT decreased by more than 17 U/L compared to the baseline.
Time frame: Up to 12 weeks
Fasting blood glucose, fasting insulin level, HOMA-IR, HbA1c, body weight, and BMI.
Changes in glucose metabolism related indicators compared to baseline.
Time frame: Up to 12 weeks
Cmax
Single-Dose Pharmacokinetic (PK) Parameter: Maximum observed plasma concentration.
Time frame: Up to 12 weeks
Tmax
Single-Dose Pharmacokinetic (PK) Parameter: time to the maximum observed plasma concentration.
Time frame: Up to 12 weeks
T1/2
Single-Dose Pharmacokinetic (PK) Parameter: elimination half-life.
Time frame: Up to 12 weeks
CL/F
Single-Dose Pharmacokinetic (PK) Parameter: apparent total plasma clearance.
Time frame: Up to 12 weeks
Vd/F
Single-Dose Pharmacokinetic (PK) Parameter: apparent volume of distribution.
Time frame: Up to 12 weeks
AUC0-∞
Single-Dose Pharmacokinetic (PK) Parameter: AUC from time zero to infinity.
Time frame: Up to 12 weeks
AUC0-24h
Single-Dose Pharmacokinetic (PK) Parameter: AUC from time zero to 24 hours.
Time frame: Up to 12 weeks
Cmax,ss
Multiple-Dose Pharmacokinetic (PK) Parameter: Steady-state peak concentration.
Time frame: Up to 12 weeks
Tmax,ss
Multiple-Dose Pharmacokinetic (PK) Parameter: steady-state time to peak.
Time frame: Up to 12 weeks
Cmin,ss
Multiple-Dose Pharmacokinetic (PK) Parameter: steady-state trough concentration.
Time frame: Up to 12 weeks
Cavg,ss
Multiple-Dose Pharmacokinetic (PK) Parameter: mean steady-state blood drug concentration.
Time frame: Up to 12 weeks
T1/2,ss
Multiple-Dose Pharmacokinetic (PK) Parameter: elimination half-life.
Time frame: Up to 12 weeks
AUCtau
Multiple-Dose Pharmacokinetic (PK) Parameter: AUC over one dosing interval.
Time frame: Up to 12 weeks
Rac
Multiple-Dose Pharmacokinetic (PK) Parameter: accumulation factor.
Time frame: Up to 12 weeks
The percentage change of sex hormone-binding globulin (SHBG) from baseline.
Pharmacodynamics
Time frame: Up to 12 weeks
Change in the Health Survey Short Form (SF-36) relative to baseline.
Patient-reported outcome
Time frame: Baseline to day 85
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