NASHPhase 2NCT07198386

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

A Phase 2 study testing CS060380 in people with NASH, run by Cascade Pharmaceuticals, Inc at 8 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: NASH
What is being tested?: CS060380
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 8 sitesChina
Study dates: 30 Sep 2025to 30 Nov 2026
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 48Show fewer

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).
When screening, HIV antibody positive and syphilis spiral antibody positive.
Pregnant and lactating women.
Laboratory test:
PLT<LLN.
TBIL > 1.2×ULN, Gilbert Syndrome.
ALT or AST > 5 × ULN.
eGFR < 50 mL/min/1.73 m².
IRN > 1.5.
THS or FT4 abnormality.
Cardiac Troponin > ULN.
The following medication history existed before randomization:
No stable dose of sodium-glucose cotransporter-2 was received within 6 months prior to randomization(SGLT2), PCSK9 inhibitors (unless SGLT2 and PCSK9 inhibitor drugs have been used at a stable dose for at least 6 months).
Use of an excessively high dose of vitamin E within 6 months prior to randomization (unless the dose is stable and <400 IU/d), pioglitazone, glucagon-like peptide-1 (GLP-1) receptor agonists GIPR/GLP-1R dual agonists, GIPR/GLP-1R/GCGR triple agonists, compound Oral antidiabetic (OAD) regimens (three or more OADs).
Those who have received treatment for NAFLD/NASH including but not limited to the following within 3 months prior to randomization Drugs, FXR agonists, FGF21 analogues, DGAT2 inhibitors, PDE inhibitors Agents, other THR-β agonists, obeticholic acid, etc.
During the first 3 months prior to the randomization, the patients did not use the hypoglycemic drugs at a stable dose (such as metformin, sulfonylurea drugs, dipeptidyl peptidase 4 inhibitors, α-glucosidase inhibitors, thiazolidinediones (except pioglitazone), etc.) (unless these hypoglycemic drugs had been used at a stable dose for at least 3 months).
The fluctuation range of insulin dosage within the previous 3 months was ≥ 30%.
For the first 3 months prior to the randomization, no stable dose of lipid-lowering drugs (such as statins, fibrates, cholesterol absorption inhibitors (such as ezetimibe), niacin, omega-3 fatty acids, etc.) was used (unless these lipid-lowering drugs had been used at a stable dose for at least 3 months).
Within 3 months prior to randomization (for unmarketed drugs or devices) or within 5 half-lives (for marketed drugs), the patient has participated in other investigational product or device clinical trials (if there is evidence that the patient participated in a clinical trial, received treatment in the inactive drug group, or has been removed from the group without receiving treatment with the investigational product, they are eligible to participate in this study for screening).
Having received drug treatment that includes but is not limited to the following drugs that may cause NAFLD/NASH for at least 2 weeks within one month prior to boarding the machine For example, total parenteral nutrition (TPN), amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, estrogen with doses greater than those used for contraception or hormone replacement, anabolic steroids, valproic acid and other known liver-toxic drugs.
During the randomization period of the previous 4 weeks or during the clinical study period, the use of hepatoprotective drugs not permitted by the protocol, including but not limited to, silymarin (Bixin), bicyclol, glycyrrhizin preparations (isoglycyrrhizinate, compound glycyrrhizin, glycyrrhizine dihydrogen monophosphate, etc.) and others (except for hepatoprotective drugs such as ursodeoxycholic acid, polyene phosphatidylcholine, reduced glutathione, etc. that have been used stably for at least 3 months with low risk).
Received anticoagulant treatment within 2 weeks prior to randomization: drugs that increase INR (e.g., FXa inhibitors, warfarin, heparin, etc.).
Those who have used CYP3A enzyme strong suppressors, CYP3A enzyme strong inducers, inhibitors of P-gp or BCRP transporters that may affect the metabolism or absorption of this drug within 14 days prior to randomization or at least 5 half-lives (whichever is longer).
Other circumstances that the researcher deems unsuitable for inclusion in the trial.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

China8 sites

The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, 311121
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu
Ruian People's Hosptial
Wenzhou, Zhejiang
Xiamen Hospital of T.C,M.
Xiamen, Fujian

Other trials in China

About this study

Official title: 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).

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

Read the 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
Being tested: CS060380, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CS060380Drug
Oral QD
PlaceboDrug
Oral QD

Study groups in NCT07198386
Study group	Role	What they receive
Part A: Group A of 0.25 mg CS060380	Experimental	Take five tablets of 0.05mg CS060380 daily for 12 weeks. Receives: 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. Receives: Drug: CS060380; Drug: Placebo
Part A: Placebo	Placebo comparator	Take five tablets of placebo daily for 12 weeks. Receives: 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. Receives: Drug: CS060380; Drug: Placebo
Part B: Group D of 2 mg CS060380	Experimental	Take four tablets of 0.5mg CS060380 daily for 12 weeks. Receives: Drug: CS060380
Part B: Placebo	Placebo comparator	Take four tablets of placebo daily for 12 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

MRI-PDFF
To assess the changes in liver steatosis through magnetic resonance imaging (MRI) proton density fat fraction (PDFF) from baseline to Week 12.
Measured: D85

Secondary outcomes (22)

AE, SAE, Vital signs, Physical examination, 12-ECG, Thyroid function, laboratory tests.
Safety and Tolerability.
Measured: 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.
Measured: Up to 12 weeks
Hypersensitive C-reactive protein
The change of hypersensitive C-reactive protein from baseline.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 weeks
Cmax
Single-Dose Pharmacokinetic (PK) Parameter: Maximum observed plasma concentration.
Measured: Up to 12 weeks
Tmax
Single-Dose Pharmacokinetic (PK) Parameter: time to the maximum observed plasma concentration.
Measured: Up to 12 weeks
T1/2
Single-Dose Pharmacokinetic (PK) Parameter: elimination half-life.
Measured: Up to 12 weeks
CL/F
Single-Dose Pharmacokinetic (PK) Parameter: apparent total plasma clearance.
Measured: Up to 12 weeks
Vd/F
Single-Dose Pharmacokinetic (PK) Parameter: apparent volume of distribution.
Measured: Up to 12 weeks
AUC0-∞
Single-Dose Pharmacokinetic (PK) Parameter: AUC from time zero to infinity.
Measured: Up to 12 weeks
AUC0-24h
Single-Dose Pharmacokinetic (PK) Parameter: AUC from time zero to 24 hours.
Measured: Up to 12 weeks
Cmax,ss
Multiple-Dose Pharmacokinetic (PK) Parameter: Steady-state peak concentration.
Measured: Up to 12 weeks
Tmax,ss
Multiple-Dose Pharmacokinetic (PK) Parameter: steady-state time to peak.
Measured: Up to 12 weeks
Cmin,ss
Multiple-Dose Pharmacokinetic (PK) Parameter: steady-state trough concentration.
Measured: Up to 12 weeks
Cavg,ss
Multiple-Dose Pharmacokinetic (PK) Parameter: mean steady-state blood drug concentration.
Measured: Up to 12 weeks
T1/2,ss
Multiple-Dose Pharmacokinetic (PK) Parameter: elimination half-life.
Measured: Up to 12 weeks
AUCtau
Multiple-Dose Pharmacokinetic (PK) Parameter: AUC over one dosing interval.
Measured: Up to 12 weeks
Rac
Multiple-Dose Pharmacokinetic (PK) Parameter: accumulation factor.
Measured: Up to 12 weeks
The percentage change of sex hormone-binding globulin (SHBG) from baseline.
Pharmacodynamics
Measured: Up to 12 weeks
Change in the Health Survey Short Form (SF-36) relative to baseline.
Patient-reported outcome
Measured: Baseline to day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 202530 Nov 2026

First posted30 Sep 2025
Study start30 Sep 2025
Primary completion21 Jul 2026
Study completion30 Nov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NASHStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07198386
Sponsor's protocol ID: CS060380-NASH-CN-IIa-02
Status last verified: Mar 2026
First submitted: 8 Sep 2025
Last updated: 29 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
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Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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RecruitingPhase 1
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All NASH trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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).
ClinicalTrials.gov ID: NCT07198386
Acronym / sponsor ID: CS060380-NASH-CN-IIa-02
Conditions: NASH
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 120 participants (actual)
Lead sponsor: Cascade Pharmaceuticals, IncUniversity, hospital or other
Study start: 30 Sep 2025 (actual)
Primary completion: 21 Jul 2026 (actual)
Study completion: 30 Nov 2026 (estimated)
First posted: 30 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Part A: Group A of 0.25 mg CS060380	Experimental	Drug: CS060380Take five tablets of 0.05mg CS060380 daily for 12 weeks.
Part A: Group B of 0.5 mg CS060380	Experimental	Drug: CS060380, Drug: PlaceboTake one tablet of 0.5mg CS060380 and four tablets of placebo daily for 12 weeks.
Part A: Placebo	Placebo comparator	Drug: PlaceboTake five tablets of placebo daily for 12 weeks.
Part B: Group C of 1 mg CS060380	Experimental	Drug: CS060380, Drug: PlaceboTake two tablets of 0.5mg CS060380 and two tablets of placebo daily for 12 weeks.
Part B: Group D of 2 mg CS060380	Experimental	Drug: CS060380Take four tablets of 0.5mg CS060380 daily for 12 weeks.
Part B: Placebo	Placebo comparator	Drug: PlaceboTake four tablets of placebo daily for 12 weeks.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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:
Avoid strenuous exercise at least 24 hours before each visit or blood draw.

Key exclusion criteria (48 listed)

The following liver diseases or past medical history were present at the time of screening:
During screening, the following medical history was present:
The following concomitant diseases or conditions occur during the screening period:
The following medication history existed before randomization:
Other circumstances that the researcher deems unsuitable for inclusion in the trial.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CS060380Oral QD	Drug	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
PlaceboOral QD	Drug	Part A: Group B of 0.5 mg CS060380, Part A: Placebo, Part B: Group C of 1 mg CS060380, Part B: Placebo

Primary outcome

MRI-PDFF
Time frame: D85
To assess the changes in liver steatosis through magnetic resonance imaging (MRI) proton density fat fraction (PDFF) from baseline to Week 12.

22 secondary outcomes

AE, SAE, Vital signs, Physical examination, 12-ECG, Thyroid function, laboratory tests.
Time frame: Up to 12 weeks
ALT, AST, GGT, TC, LDL-C, HDL-C, TG, ApoB, Lp(a), The ApoB/ApoA ratio.
Time frame: Up to 12 weeks
Hypersensitive C-reactive protein
Time frame: Up to 12 weeks
MRI-PDFF relative baseline decrease percentage
Time frame: Baseline to Day 85
ALT relative to baseline decrease ratio
Time frame: Up to 12 weeks
Fasting blood glucose, fasting insulin level, HOMA-IR, HbA1c, body weight, and BMI.
Time frame: Up to 12 weeks
Cmax
Time frame: Up to 12 weeks
Tmax
Time frame: Up to 12 weeks
T1/2
Time frame: Up to 12 weeks
CL/F
Time frame: Up to 12 weeks
Vd/F
Time frame: Up to 12 weeks
AUC0-∞
Time frame: Up to 12 weeks
AUC0-24h
Time frame: Up to 12 weeks
Cmax,ss
Time frame: Up to 12 weeks
Tmax,ss
Time frame: Up to 12 weeks
Cmin,ss
Time frame: Up to 12 weeks
Cavg,ss
Time frame: Up to 12 weeks
T1/2,ss
Time frame: Up to 12 weeks
AUCtau
Time frame: Up to 12 weeks
Rac
Time frame: Up to 12 weeks
The percentage change of sex hormone-binding globulin (SHBG) from baseline.
Time frame: Up to 12 weeks
Change in the Health Survey Short Form (SF-36) relative to baseline.
Time frame: Baseline to day 85

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.

Related trials for NASH

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Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Junping Shi, MD principal investigator

The Affiliated Hospital of Hangzhou Normal University

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CS060380 in people with NASH, run by Cascade Pharmaceuticals, Inc at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI-PDFF (time frame: D85). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07198386.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.