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Metabolic Dysfunction-associated Steatohepatitis (MASH)Phase 2NCT07466017

A Study of CS060380 Tablets in Patients With MASH and Obesity

A Phase 2 study testing semaglutide and CS060380 in people with Metabolic Dysfunction-associated Steatohepatitis (MASH) and Obesity, run by Cascade Pharmaceuticals, Inc at 12 sites in China.

Active, not recruiting

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

Official record
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Trial summary

this study is looking at a new investigational medicine called CS060380, when used together with semaglutide, in adults who have both metabolic dysfunction-associated steatohepatitis (MASH) and obesity. MASH is a condition where too much fat builds up in the liver, leading to inflammation and damage. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
semaglutide and CS060380
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
130 participants
Where
12 sitesChina
Study dates
2 Apr 2026to 30 Jul 2027
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 65 years (inclusive), male or female.
  • Liver fat content ≥10% as measured by MRI-PDFF at screening.
  • BMI ≥30 kg/m².
  • Body weight change ≤5% during the 3 months prior to screening with only diet and exercise control (self-reported). The weight change is calculated as: (Maximum weight - Minimum weight within 3 months before screening) / Maximum weight × 100%.
  • Glycated hemoglobin (HbA1c) <6.5% at screening.
  • Fasting venous blood glucose <7 mmol/L at screening.
  • All participants with reproductive capacity agreed to take effective contraceptive measures for themselves and their partners from the screening period until the end of the trial (physical contraception was used before and during the trial, and only drug contraception was used when necessary after or during the trial), and there were no recent plans for sperm donation, egg donation, or childbearing.
  • Voluntary consent to participate in this clinical trial and provide written informed consent.

Who cannot join

  • Diagnosis of type 2 diabetes mellitus, type 1 diabetes mellitus, monogenic diabetes, diabetes due to pancreatic injury (e.g., post-pancreatitis diabetes), or other secondary diabetes prior to randomization.
  • ≥2 episodes of hypoglycemia (blood glucose ≤2.8 mmol/L in non-diabetic patients) within 6 months before screening.
  • Impaired gastrointestinal function or gastrointestinal disease that may affect the absorption of oral medications, such as severe gastrointestinal diseases (peptic ulcer, erosive or atrophic gastritis), partial gastrectomy, or grade >1 gastrointestinal symptoms (e.g., nausea, vomiting, or diarrhea) at screening.
  • Thyroid diseases including hyperthyroidism and hypothyroidism [participants with benign thyroid lesions (e.g., thyroid nodules) may participate in this study] or pituitary diseases, or long-term use of thyroid hormone replacement therapy, antithyroid drugs, or drugs that may affect thyroid hormone production and/or interfere with thyroid function (including but not limited to methimazole, propylthiouracil, tyrosine kinase inhibitors, lithium, iodides, and glucocorticoids, etc.).
  • Previous diagnosis of obesity caused by endocrine diseases or single-gene mutations, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, and hypogonadism.
  • Previous bariatric surgery (including sleeve gastrectomy, Roux-en-Y gastric bypass, or combined procedures, etc.) or use of medical devices for obesity treatment, or planned such procedures during the trial; except for liposuction or abdominal lipectomy performed more than 1 year before screening; adjustable gastric banding with band removal more than 1 year before screening; intragastric balloon removal more than 1 year before screening.
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  • Any contraindication to MRI scanning (including but not limited to severe claustrophobia, coronary artery stents, coronary implant devices, waist circumference exceeding scanner capacity making MRI-PDFF examination impossible). If coronary stents or other devices do not interfere with the function of the MRI machine, the investigator may decide at their discretion whether to allow inclusion.
  • Blood donation within 3 months before screening, or total blood loss (excluding female physiological bleeding) due to blood donation or other reasons reaching or exceeding 400 mL within 6 months.
  • Use of glucagon-like peptide-1 receptor agonists (GLP-1 RA) or compound preparations containing GLP-1 RA components within 3 months before randomization.
  • Use of any approved or unapproved weight-loss drugs (e.g., orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, etc.) or drugs affecting body weight (including Chinese herbal medicines), health products, meal replacements, or weight-loss acupuncture treatments within 3 months before randomization.
  • Use of drugs that may cause significant weight gain: systemic glucocorticoid therapy for more than 1 week; tricyclic antidepressants; antipsychotic or antiepileptic drugs (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine hydrochloride, clozapine, olanzapine, valproic acid and its derivatives, lithium preparations, thioridazine), etc., within 3 months before randomization.
  • History of treatment for more than 1 week such as total parenteral nutrition (TPN), amiodarone, methotrexate, tetracycline, tamoxifen, estrogens in excess of hormone replacement doses, anabolic steroids, valproic acid, anticholinergic drugs, or other known hepatotoxic drugs within 3 months before randomization.
  • Use of vitamin E (≥800-1000 IU/day), polyunsaturated fatty acids, ursodeoxycholic acid, fibrates, statins within 3 months before randomization, unless the participant had a stable dose for 3 months before screening, continued taking until the screening visit, and will continue the same medication regimen throughout the study participation period.
  • Use of metformin, SGLT2 inhibitors, and other hypoglycemic agents within 3 months before randomization.
  • Use of strong inhibitors of CYP3A enzymes, strong inducers of CYP3A enzymes, or inhibitors of P-gp or BCRP transporters that may affect the metabolism or absorption of the study drug within 14 days before randomization or at least 5 half-lives (whichever is longer), see Appendix 1.
  • Use of hepatoprotective drugs not permitted by the protocol within 4 weeks before randomization or planned use during the clinical study, including silymarin, bicyclol, glycyrrhizin preparations (magnesium isoglycyrrhizinate, compound glycyrrhizin, diammonium glycyrrhizinate), except for ursodeoxycholic acid, polyene phosphatidylcholine, and reduced glutathione that have been stably used for ≥3 months before randomization.
  • Anticoagulant therapy within 2 weeks before randomization: drugs that increase INR (e.g., FXa inhibitors, warfarin, heparin, etc.).
  • History of heavy alcohol consumption for more than 3 consecutive months within 1 year before screening. Note: Heavy alcohol consumption is defined as an average weekly alcohol intake of more than approximately 7 standard drinks for women and more than approximately 14 standard drinks for men. One standard drink is defined as any beverage containing 14g of pure alcohol, such as 12 oz/360 ml of beer (5% alcohol), 8 oz/240 ml of malt liquor (7% alcohol), 5 oz/150 ml of wine (12% alcohol), 1.5 oz/45 ml of spirits (40% alcohol).
  • Hemoglobin ≤90 g/L at screening.
  • ALT ≥2.5×ULN at screening.
  • AST ≥2.5×ULN at screening.
  • Serum albumin (ALB) <35 g/L at screening.
  • International normalized ratio (INR) >1.2 at screening.
  • Total bilirubin (TBil) >1.2×ULN at screening (except for Gilbert's syndrome).
  • Serum amylase or lipase ≥3×ULN at screening.
  • Calcitonin ≥50 ng/L at screening.
  • Estimated glomerular filtration rate (eGFR) <50 mL/min/1.73m² at screening.
  • Clinically relevant abnormalities on 12-lead ECG that, in the investigator's judgment, may affect participant safety or the interpretation of study results, such as: at screening, QTcF interval corrected by Fridericia >450 ms (males) or >470 ms (females) [Fridericia formula: QTcF = QT/(RR^0.33)].
  • Uncontrolled hypertension: sitting systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg.
  • Previous history of acute or chronic pancreatitis, or acute or chronic pancreatitis at screening.
  • History of liver cirrhosis (e.g., the participant has undergone liver histopathological examination showing cirrhosis, or endoscopic examination suggesting esophageal and gastric varices).
  • Including other liver diseases or liver disease history, such as: PBC, PSC, alcoholic liver disease, definite autoimmune liver disease or coexisting hepatitis, drug-induced liver injury, suspected or confirmed Gilbert syndrome or Wilson disease; homozygous α-1-antitrypsin deficiency; all primary iron overload diseases (including but not limited to hereditary hemochromatosis, non-hemochromatosis primary iron overload such as ceruloplasminemia, congenital transferrin deficiency syndrome, etc.) or some secondary iron overload diseases (including but not limited to transfusion-dependent iron overload, ineffective hematopoiesis-related iron overload such as MDS and sideroblastic anemia, copper-induced Parkinsonism secondary iron overload, long-term excessive iron metabolism intake, etc.), but MASH metabolism-related iron overload is excluded; drug-induced liver disease; known biliary obstruction; suspected or confirmed liver cancer or any other form of liver disease except alcoholic liver steatosis and MASH (except for those related to alcohol), known biliary obstruction, suspected or confirmed liver cancer.
  • Patients with multiple endocrine neoplasia type 2 or medullary thyroid carcinoma, or a family history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
  • History of the following cardiovascular and cerebrovascular diseases within 6 months before screening: decompensated cardiac insufficiency (NYHA class III or IV), arrhythmia requiring treatment, unstable angina or myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention, stroke (ischemic or hemorrhagic) or transient ischemic attack.
  • History of malignant tumor within 5 years (excluding clinically cured cervical epithelial carcinoma, squamous cell carcinoma, or basal cell carcinoma of the skin).
  • History of major depression or anxiety disorder within 2 years before screening, or current diagnosis of other mental illnesses (e.g., schizophrenia, bipolar disorder) that, in the investigator's assessment, are not suitable for participation in this trial.
  • PHQ-9 questionnaire (Depression Screening Scale) score ≥15 at screening.
  • Previous suicide attempt or suicidal behavior.
  • Known hypersensitivity to any ingredient in semaglutide injection or to other GLP-1 RA drugs or drugs with GLP-1 receptor agonist mechanism.
  • History of human immunodeficiency virus (HIV) infection at screening; history of Treponema pallidum (TP) infection (except those with stable conditions judged by the investigator as suitable for inclusion in this trial); positive for hepatitis B surface antigen (HBsAg) [except those with HBV-DNA results below the lower limit of detection], positive for hepatitis C virus antibody.
  • Unwilling to cooperate, or unable to cooperate, or incapable of completing the clinical trial.
  • Suspected or confirmed history of drug or substance abuse.
  • Pregnant or lactating women; female participants of childbearing potential or those with menopause less than 12 months must have a negative pregnancy test during the screening period.
  • Participation in other drug clinical trials within the last 3 months.
  • In the investigator's judgment, the participant is not suitable to participate in this clinical trial.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510150

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Nanjing Jiangning Hospital

    Nanjing, Jiangsu, 211100

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200001

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Shanghai First People's Hospital

    Shanghai, Shanghai Municipality, 200080

  • Tongren Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200336

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050031

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of CS060380 Tablets in Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH) and Obesity.

this study is looking at a new investigational medicine called CS060380, when used together with semaglutide, in adults who have both metabolic dysfunction-associated steatohepatitis (MASH) and obesity. MASH is a condition where too much fat builds up in the liver, leading to inflammation and damage. Obesity is a major risk factor for this condition.

This is a Phase II clinical trial, which means we are testing the medicine to see if it works and is safe. The study will last up to 54 weeks, which is a little over a year. It includes:

Read more
  • A screening period of up to 2 weeks to check if you are eligible to take part.
  • A 36-week double-blind treatment period, where you will be randomly assigned (like flipping a coin) to receive either the study drug CS060380 or a placebo (an inactive pill that looks like the study drug). Both groups will also receive semaglutide, which is an approved medicine for weight management. Neither you nor your doctor will know which treatment you are receiving.
  • A 16-week open-label period, where all participants will receive CS060380. The main goal of this study is to see how the study drug affects the amount of fat in the liver, measured by a special MRI scan, and body weight. We will also monitor your overall health and safety throughout the study by checking your vital signs, doing blood and urine tests, and asking about any side effects you might experience.

About 120 participants will take part in this study at almost 15 different hospitals across China, with Ruijin Hospital in Shanghai as the main study site.

Read the detailed description

The total study duration will not exceed 54 weeks, consisting of: screening period (up to 2 weeks), 36-week double-blind treatment period, and 16-week open-label period.

  1. The double-blind treatment period will employ a randomized, double-blind, placebo-controlled, parallel-group design.
  2. During the open-label period, all participants will receive CS060380.
  3. This study will enroll participants with MASH and obesity. About 120 participants are planned for enrollment.
  4. Eligible participants will be randomized in a 1:1 ratio to Control Group A (60 participants) and Experimental Group B (60 participants).
  5. Both groups will receive semaglutide 1.7 mg as background therapy. Control Group A will receive placebo, while Experimental Group B will receive CS060380 1.0 mg.
  6. Interim analyses will be conducted when approximately 80% of participants complete Week 16 and Week 24 visits.
  7. The sponsor will decide whether to continue the open-label study based on safety and efficacy data.
Being tested
semaglutide, CS060380, Placebo
Keywords
Metabolic Dysfunction-Associated Steatohepatitis, MASH, Obesity, CS060380, THR-beta agonist, Semaglutide, Phase 2 Clinical Trial
Medical subject headings
Obesity

What participants receive

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

  • semaglutideDrug

    Semaglutide 1.7 mg as the background therapy for all participants

  • CS060380Drug

    CS060380 1.0 mg tablets for the treatment of metabolic dysfunction-associated steatohepatitis complicated with obesity

  • PlaceboDrug

    Placebo tablets matching CS060380 of double-blind control for 36 weeks

Study groups in NCT07466017
Study groupRoleWhat they receive
Placebo + SemaglutidePlacebo comparatorParticipants receive CS060380 placebo tablets orally once daily in combination with semaglutide 1.7 mg subcutaneously once weekly for 36 weeks during the double-blind treatment period.
Receives: Drug: semaglutide; Drug: Placebo
CS060380 1.0 mg + SemaglutideExperimentalParticipants receive CS060380 1.0 mg tablets orally once daily in combination with semaglutide 1.7 mg subcutaneously once weekly for 36 weeks during the double-blind treatment period.
Receives: Drug: semaglutide; Drug: CS060380

What is being measured

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

  1. Percentage change in liver fat content from baseline to Week 36 (MRI-PDFF)

    Percentage change in liver fat content measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) from baseline to Week 36 of the double-blind treatment period.

    Measured: Baseline, Week 36

Secondary outcomes (2)

  1. Percentage change in body weight measured by weight scale from baseline to Week 36

    Percentage change in body weight from baseline to Week 36, measured using a weight scale

    Measured: Baseline, Week 36

  2. Percentage change in liver fat content (MRI-PDFF) from baseline to week 24

    Percentage change in liver fat content as measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) from baseline to Week 24

    Measured: Baseline, Weeks 24

Timeline

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

  1. First posted12 Mar 2026
  2. Study start2 Apr 2026
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Jul 2027 (estimated)

Resources

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
Model description
this is a randomized, double-blind, placebo-controlled, parallel-group Phase II study with a 36-week double-blind treatment period followed by a 16-week open-label extension. During the double-blind period, participants receive either CS060380 1.0 mg or placebo in combination with semaglutide 1.7 mg as background therapy. In the open-label period, all participants receive CS060380. Interim analyses are planned when approximately 80% of participants complete Week 16 and Week 24 visits.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07466017
Sponsor's protocol ID
CS060380-MASH-CN-II-03
Other IDs
2024LP01824, CS060380-MASH-CN-II-03
Status last verified
Aug 2026
First submitted
2 Mar 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Newsome PN, Buchholtz K, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal AJ, Sejling AS, Harrison SA; NN9931-4296 Investigators. A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. N Engl J Med. 2021 Mar 25;384(12):1113-1124. doi: 10.1056/NEJMoa2028395. Epub 2020 Nov 13.

    PubMed 33185364

  • Chinese Nutrition Society Obesity Prevention and Control Branch, et al. Expert consensus on obesity prevention and control among Chinese residents [J]. J Xi'an Jiaotong Univ Med Sci. 2022;43(4):619-631.

  • Fan JG, et al. Guidelines for the prevention and treatment of metabolic-associated fatty liver disease (2024 edition). J Pract Hepatol. 2024;27(4):494-510.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing semaglutide and CS060380 in people with Metabolic Dysfunction-associated Steatohepatitis (MASH) and Obesity, run by Cascade Pharmaceuticals, Inc at 12 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 45 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

Percentage change in liver fat content from baseline to Week 36 (MRI-PDFF) (time frame: Baseline, Week 36). 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 NCT07466017, which also lists 3 linked publications.

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 10 Aug 2026.

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