[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cascade Pharmaceuticals, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100628774","phase-2-a-study-of-cs060380-tablets-in-patients-with-mash-and-obesity-100628774",false,"NCT07466017","A Study of CS060380 Tablets in Patients With MASH and Obesity","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.","Inclusion Criteria:\n\n* Age 18 to 65 years (inclusive), male or female.\n* Liver fat content ≥10% as measured by MRI-PDFF at screening.\n* BMI ≥30 kg\u002Fm².\n* 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) \u002F Maximum weight × 100%.\n* Glycated hemoglobin (HbA1c) \\\u003C6.5% at screening.\n* Fasting venous blood glucose \\\u003C7 mmol\u002FL at screening.\n* All participants of childbearing potential agree to use effective physical and\u002For pharmacological contraceptive measures from the screening period until 3 months after the end of the trial, and have no recent plans for sperm donation, egg donation, or pregnancy.\n* Voluntary consent to participate in this clinical trial and provide written informed consent.\n\nExclusion Criteria:\n\nDiagnosis 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.\n\n* ≥2 episodes of hypoglycemia (blood glucose ≤2.8 mmol\u002FL in non-diabetic patients) within 6 months before screening.\n* 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.\n* 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\u002For interfere with thyroid function (including but not limited to methimazole, propylthiouracil, tyrosine kinase inhibitors, lithium, iodides, and glucocorticoids, etc.).\n* 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.\n* 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.\n* 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.\n* 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.\n* Use of glucagon-like peptide-1 receptor agonists (GLP-1 RA) or compound preparations containing GLP-1 RA components within 3 months before randomization.\n* Use of any approved or unapproved weight-loss drugs (e.g., orlistat, lorcaserin, phentermine\u002Ftopiramate, naltrexone\u002Fbupropion, etc.) or drugs affecting body weight (including Chinese herbal medicines), health products, meal replacements, or weight-loss acupuncture treatments within 3 months before randomization.\n* 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.\n* 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.\n* Use of vitamin E (≥800-1000 IU\u002Fday), 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.\n* Use of metformin, SGLT2 inhibitors, and other hypoglycemic agents within 3 months before randomization.\n* 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.\n* 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.\n* Anticoagulant therapy within 2 weeks before randomization: drugs that increase INR (e.g., FXa inhibitors, warfarin, heparin, etc.).\n* 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\u002F360 ml of beer (5% alcohol), 8 oz\u002F240 ml of malt liquor (7% alcohol), 5 oz\u002F150 ml of wine (12% alcohol), 1.5 oz\u002F45 ml of spirits (40% alcohol).\n* Hemoglobin ≤90 g\u002FL at screening.\n* ALT ≥2.5×ULN at screening.\n* AST ≥2.5×ULN at screening.\n* Serum albumin (ALB) \\\u003C35 g\u002FL at screening.\n* International normalized ratio (INR) \\>1.2 at screening.\n* Total bilirubin (TBil) \\>1.2×ULN at screening (except for Gilbert's syndrome).\n* Serum amylase or lipase ≥3×ULN at screening.\n* Calcitonin ≥50 ng\u002FL at screening.\n* Estimated glomerular filtration rate (eGFR) \\\u003C50 mL\u002Fmin\u002F1.73m² at screening.\n* 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\u002F(RR\\^0.33)\\].\n* Uncontrolled hypertension: sitting systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg.\n* Previous history of acute or chronic pancreatitis, or acute or chronic pancreatitis at screening.\n* History of liver cirrhosis (e.g., the participant has undergone liver histopathological examination showing cirrhosis, or endoscopic examination suggesting esophageal and gastric varices).\n* Other liver diseases or history of liver diseases, including but not limited to: primary biliary cholangitis, primary sclerosing cholangitis, alcoholic liver disease, definite autoimmune liver disease or superimposed hepatitis, drug-induced liver injury, suspected or confirmed Gilbert's syndrome or Wilson's disease; homozygous α-1-antitrypsin deficiency; history of hemochromatosis or iron overload; drug-induced liver disease; known bile duct obstruction; suspected or confirmed hepatocellular carcinoma or any other form of liver disease except non-alcoholic hepatic steatosis and MASH, known bile duct obstruction, suspected or confirmed hepatocellular carcinoma.\n* 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.\n* 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.\n* History of malignant tumor within 5 years (excluding clinically cured cervical epithelial carcinoma, squamous cell carcinoma, or basal cell carcinoma of the skin).\n* 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.\n* PHQ-9 questionnaire (Depression Screening Scale) score ≥15 at screening.\n* Previous suicide attempt or suicidal behavior.\n* Known hypersensitivity to any ingredient in semaglutide injection or to other GLP-1 RA drugs or drugs with GLP-1 receptor agonist mechanism.\n* 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.\n* Unwilling to cooperate, or unable to cooperate, or incapable of completing the clinical trial.\n* Suspected or confirmed history of drug or substance abuse.\n* 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.\n* Participation in other drug clinical trials within the last 3 months.\n* In the investigator's judgment, the participant is not suitable to participate in this clinical trial.","ALL","18 Years","65 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.\n\nThis 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:\n\n* A screening period of up to 2 weeks to check if you are eligible to take part.\n* 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.\n* 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.\n\nAbout 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.",[27,28],"Metabolic Dysfunction-associated Steatohepatitis (MASH)","Obesity",[30,31,28,32,33,34,35],"Metabolic Dysfunction-Associated Steatohepatitis","MASH","CS060380","THR-beta agonist","Semaglutide","Phase 2 Clinical Trial","RECRUITING","2026-05-18",{"date":39,"type":40},"2026-05-20","ACTUAL",{"date":42,"type":40},"2026-04-02",{"date":44,"type":21},"2027-07-30",{"name":46,"class":47},"Cascade Pharmaceuticals, Inc","OTHER",12,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100608194","phase-2-trial-of-cs060380-tablets-for-non-alcoholic-steatohepatitis-nash-100608194","NCT07198386","Trial of CS060380 Tablets for Non-alcoholic Steatohepatitis (NASH)","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).","Inclusion Criteria:\n\n1. Men or women aged 18 to 70 (including the boundary value).\n2. 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..\n3. 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.\n4. 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:\n\n   * 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.\n   * 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.\n5. Avoid strenuous exercise at least 24 hours before each visit or blood draw.\n6. Sign the ICF before the experiment and be able to complete the research as required by the protocol.\n\nExclusion Criteria:\n\n1. The following liver diseases or past medical history were present at the time of screening:\n\n   1. 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.\n   2. Has a history of liver cirrhosis.\n   3. Primary liver cancer. AFP \\> 50 μg\u002FL.\n2. During screening, the following medical history was present:\n\n   1. Study the history of allergies to drug ingredients and excipients.\n   2. Surgical procedures that may interfere with treatment, including but not limited to weight loss surgery, liver transplantation surgery, etc.\n   3. Screen those who have a history of malignant tumors within the previous five years.\n   4. Contraindications for any MRI scan.\n   5. Screen for a history of drug or substance abuse within the previous two years.\n   6. Screen for a history of heavy drinking for more than three consecutive months within one year prior to the screening.\n   7. Weight change ≥ 5% in the first 3 months of randomization or ≥ 10% in the first 6 months of randomization.\n   8. 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.\n   9. Merge with any of the following serious cardiovascular disease or surgical histories (including but not limited to):\n\n      1. Unstable angina pectoris occurred within 3 months prior to randomization.\n      2. Combined heart failure, NYHA ≥ Ⅲ\n      3. Myocardial infarction, shock or life-threatening arrhythmia occurred within 6 months prior to randomization.\n      4. Randomized coronary artery bypass grafting surgery or percutaneous coronary intervention within the first 6 months.\n3. The following concomitant diseases or conditions occur during the screening period:\n\n   1. T1DM, uncontrolled T2DM (HbA1c \\> 9 % ), history of severe hypoglycemia.\n   2. Intestinal diseases that affect the absorption of oral medications.\n   3. There are thyroid diseases, including hyperthyroidism and hypothyroidism or pituitary disorders.\n   4. 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.\n   5. Uncontrolled hypertension was present during screening: systolic blood pressure \\>160mmHg or diastolic blood pressure \\>100mmHg even under regular medication control.\n   6. When screening QTcF \\>450 ms (for males) or \\>470 ms (Female).\n   7. When screening, HIV antibody positive and syphilis spiral antibody positive.\n   8. Pregnant and lactating women.\n   9. Laboratory test:\n\n      1. PLT\\\u003CLLN.\n      2. TBIL \\> 1.2×ULN, Gilbert Syndrome.\n      3. ALT or AST \\> 5 × ULN.\n      4. eGFR \\\u003C 50 mL\u002Fmin\u002F1.73 m².\n      5. IRN \\> 1.5.\n      6. THS or FT4 abnormality.\n      7. Cardiac Troponin \\> ULN.\n4. The following medication history existed before randomization:\n\n   1. 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).\n   2. Use of an excessively high dose of vitamin E within 6 months prior to randomization (unless the dose is stable and \\\u003C400 IU\u002Fd), pioglitazone, glucagon-like peptide-1 (GLP-1) receptor agonists GIPR\u002FGLP-1R dual agonists, GIPR\u002FGLP-1R\u002FGCGR triple agonists, compound Oral antidiabetic (OAD) regimens (three or more OADs).\n   3. Those who have received treatment for NAFLD\u002FNASH 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.\n   4. 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).\n   5. The fluctuation range of insulin dosage within the previous 3 months was ≥ 30%.\n   6. 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).\n   7. 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).\n   8. Having received drug treatment that includes but is not limited to the following drugs that may cause NAFLD\u002FNASH 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.\n   9. 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).\n   10. Received anticoagulant treatment within 2 weeks prior to randomization: drugs that increase INR (e.g., FXa inhibitors, warfarin, heparin, etc.).\n   11. 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).\n5. Other circumstances that the researcher deems unsuitable for inclusion in the trial.","70 Years",{"count":20,"type":21},[24],"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:\n\n* After 12 weeks of administration, what was the percentage change in fat content evaluated by MRI-PDFF compared to the baseline？\n* 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.\n\nParticipants will:\n\n* Take CS060380 tablets or a placebo every day for 12 weeks\n* Visit the clinic for checkups and tests at the frequency required by the protocol\n* Keep a diary of their symptoms and the number of tablets taken",[61],"NASH","2026-03-12",{"date":64,"type":40},"2026-03-13",{"date":66,"type":40},"2025-09-30",{"date":68,"type":21},"2026-11-30",{"name":46,"class":47},8,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100614650","phase-3-a-study-of-cs0159-in-patients-with-pbc-with-inadequate-response-or-intolerance-to-udca-100614650","NCT07282353","A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA","A Randomized, Double-Blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of CS0159 in Patients With Primary Biliary Cholangitis (PBC) With Inadequate Response or Intolerance to Ursodeoxycholic Acid (UDCA)","Inclusion Criteria:\n\n1. Must have given written informed consent (signed and dated) and any authorizations required by local law;\n2. When signing ICF age ≥18 years ≤75 years, male or female;\n3. Meets the diagnostic criteria of PBC, based on any two of the following criteria:\n\n   1. History of ALP above 1.0× ULN for at least 6 months\n   2. Positive antimitochondrial antibody (AMA) titer (\\>1:40 on immunofluorescence or M2 positive by ELISA) or positive PBC- specific antinuclear antibody (ANA) (either SP100 or GP210 positive)\n   3. Documented liver biopsy results consistent with PBC;\n4. UDCA≥6 months before randomization and a stable dose ≥3 months after the efficacy was poor \\[meeting inclusion criteria (5)a\\], or UDCA was not tolerated, and stop taking UDCA (no UDCA use for ≥3 months before randomization);\n5. Central laboratory parameters measured at screening period meet the following criteria:\n\n   1. ALP ≥1.67× ULN\n   2. ALT≤5× ULN\n   3. AST ≤5× ULN\n   4. TB \\\u003C2× ULN\n   5. Estimated glomerular filtration rate (eGFR) \\> 60mL\u002Fmin\u002F1.73m2 (calculated by CKD-EPI equation)\n   6. INR ≤ 1.0× ULN. For participants on anticoagulation therapy, INR must be maintained in the range required for prophylaxis for their specific disease\n   7. Platelet count ≥ 150× 109\u002FμL (No thrombocytopenia-related treatment within the past two weeks)\n   8. Albumin\\> 35g\u002FL\n   9. White blood cells count (WBC) \\>3×109\u002FL\n   10. Absolute neutrophil count (ANC) \\>1.5×109\u002FL\n   11. Hemoglobin A1c (HbA1c) ≤9.0%;\n6. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male participants who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose.\n\n   \\-\n\nExclusion Criteria:\n\n1. Previous exposure to CS0159;\n2. History of allergy to the CS0159 or its excipients or drugs of similar chemical classes;\n3. Advanced PBC as defined by the Rotterdam criteria (albumin\\\u003C1.0×LLN AND TB \\>1.0× ULN);\n4. Patients who have had clinically significant complications of hepatic cirrhosis with clinically significant portal hypertension (CSPH), including the following:\n\n   1. History of liver transplantation, current placement on a liver transplant list, current MELD -Na score ≥ 12;\n   2. History of confirmed esophagogastric variceal bleeding;\n   3. Clinically significant ascites requiring intervention, such as sodium restriction, diuretic therapy, or therapeutic paracentesis;\n   4. Any secondary complications resulting from clinically significant ascites, such as spontaneous bacterial peritonitis, hepatorenal syndrome, or hepatic hydrothorax;\n   5. Hepatic encephalopathy requiring drug therapy;\n   6. Portopulmonary hypertension and\u002For hepatopulmonary syndrome;\n   7. Hepatocellular carcinoma;\n5. Other concomitant liver disease including:\n\n   1. Autoimmune hepatitis (AIH) (simplified AIH diagnostic score \\>6), PBC-AIH overlap syndrome, or overlap with other autoimmune liver diseases\n   2. Positive HBsAg or positive HCV RNA (tested for in case of known cured HCV infection or positive HCV Ab at screening)\n   3. Primary sclerosing cholangitis (PSC)\n   4. History or clinical evidence of Alcoholic liver disease (ALD)\n   5. Biopsy confirmed Non-alcoholic steatohepatitis (NASH)\n   6. Gilbert's Syndrome\n   7. History or evidence of alpha-1 antitrypsin deficiency\n   8. Liver stiffness measured by transient elastography (TE) \\> 16.9 Kpa;\n6. Patient has a positive test for HIV at screening, or active syphilis \\[defined as positive Treponema pallidum antibody (TP Ab) and a rapid plasma reagin (RPR) card test titer ≥1:8; for low titers (e.g., 1:1 or 1:2), clinical judgment is required to determine if it is active syphilis\\];\n7. Administration of the following medications are prohibited as specified below:\n\n   1. Use of medications, food, and drinks (e.g., grapefruit juice) that are strong or moderate CYP3A4 inhibitors or inducers within 14 days before randomization;\n   2. Use of P-glycoprotein (P-gp) substrate drugs within 14 days before randomization;\n   3. 2 months prior to randomization: fibrates, glitazones, seladelpar and elafibranor.\n   4. 3 months prior to randomization: obeticholic acid (OCA), azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, systemic corticosteroids and budesonide (˃2 weeks); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid isoniazid, or nitrofurantoin).\n   5. Patients with systemic treatment for pruritus (e.g., with bile acid sequestrants \\[BAS\\]) within 3 months prior to randomization.\n   6. 12 months prior to randomization: antibodies or immunotherapy directed against ILs or other cytokines or chemokines;\n8. Medical conditions that may cause non-hepatic increases in ALP (e.g., paget's disease);\n9. Patients with severe arrhythmia, or a QTcF interval corrected by Fridericia's formula ≥450 ms (males) or ≥470 ms (females) at screening \\[Fridericia's formula: QTcF=QT\u002F(RR\\^0.33)\\];\n10. History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the large intestine, eg, inflammatory bowel disease, prior or planned (during the study period) bariatric surgery (such as gastroplasty, roux-en-Y gastric bypass);\n11. History of malignancy (except for those with a disease-free survival of ≥5 years) or currently under evaluation for malignancy; except for cured squamous or non-invasive skin basal cell carcinoma and cervical carcinoma in situ;\n12. Drug abuse or heavy alcohol use from 12 months prior to randomization throughout the entire clinical study period. Heavy alcohol use is defined as an average weekly alcohol consumption of more than approximately 7 standard drinks for females and more than approximately 14 standard drinks for males. One standard drink is defined as any beverage containing 14g of pure alcohol, such as 12 oz\u002F360 mL of beer (5% alcohol), 8 oz\u002F240 mL of malt liquor (7% alcohol), 5 oz\u002F150 mL of wine (12% alcohol), or 1.5 oz\u002F45 mL of distilled spirits (40% alcohol);\n13. Poor blood pressure control is indicated after treatment by a systolic pressure greater than 160 mmHg or diastolic pressure greater than 100 mmHg during screening;\n14. Pregnancy, planned pregnancy, lactation;\n15. Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening;\n16. Mental instability or incompetence that may compromise the validity of informed consent or ability to adhere to study requirements;\n17. Any other condition(s) that would compromise the safety of the patient or compromise the quality of the clinical study, as judged by the investigator.\n\n    \\-","75 Years",{"count":80,"type":21},135,[82],"PHASE3","A Randomized, Double-Blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of CS0159 in Patients with Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (UDCA).",[85],"Primary Biliary Cholangitis","2025-12-29",{"date":88,"type":40},"2025-12-30",{"date":90,"type":40},"2025-12-01",{"date":92,"type":21},"2028-01-06",{"name":46,"class":47},41,""]