[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zydus Therapeutics Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":139},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,72,95,116],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100609565","phase-3-long-term-study-to-evaluate-the-safety-and-efficacy-in-participants-with-primary-biliary-cholangitis-of-saroglitazar-magnesium-v-on-clinical-outcomes-100609565",false,"NCT07216235","Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes","A Phase 3b\u002F4, Multicenter, Parallel-Group, Double-Blind, Placebo Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants With Primary Biliary Cholangitis (PBC)","EPICS-V","Inclusion Criteria:\n\nEach participant must meet all of the following criteria to be enrolled in this study:\n\n1. Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements\n2. Is an adult male or female, must be ≥18 years of age at the time of signing informed consent\n3. Is receiving ursodeoxycholic acid (UDCA) for ≥12 months with a stable dose for ≥6 months prior to screening,and expected to remain on a stable dose during the study period OR Is unable to tolerate UDCA and did not receive UDCA in the past 3 months prior to screening\n4. Has a history of confirmed PBC diagnosis, as demonstrated by the presence of ≥2 of the following 3 diagnostic factors:\n\n   i. A history of elevated ALP levels for ≥6 months prior to screening ii. Positive antimitochondrial antibodies (AMA) titer OR if AMA is negative, then positive PBC-specific antibodies iii. Liver biopsy consistent with PBC diagnosis\n5. Has documented evidence of cirrhosis and has ALP \\>ULN and TB ≤5 × ULN\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. Has consumption of 2 standard alcohol drinks per day (or 14 alcohol drinks per week) if male and 1 standard alcohol drink per day (or 7 alcohol drinks per week) if female for ≥3 consecutive months (12 consecutive weeks) within 5 years prior to screening\n2. Has known CPT B (having a score of ≥7) or CPT C (having a score of ≥10) cirrhosis classification at screening\n3. Has a Model for End-Stage Liver Disease (MELD)-Na score of ≥12 at screening\n4. Has a history or presence of any of the following other concomitant liver diseases at screening:\n\n   i. Chronic hepatitis B or C virus (HBV, HCV) infection. (Note: If a participant has been treated for the HCV infection and has been cured for a duration of \\>2 years prior to screening, they can be enrolled in the study. Participants who have seroconverted (hepatitis B surface antigen-negative and hepatitis B surface antibody-positive) may be included in this study.\n\n   ii. Primary sclerosing cholangitis iii. Alcohol-associated liver diseases iv. Autoimmune hepatitis (AIH)-PBC overlap syndrome v. Hemochromatosis vi. Metabolic dysfunction-associated steatohepatitis on historical biopsy vii. α-1 antitrypsin deficiency\n5. Has a history or presence of clinically significant hepatic decompensation, including the following:\n\n   i. Liver transplantation or currently placed on a liver transplant list ii. Complications of cirrhosis iii. Hepatorenal syndrome (Type I or II) iv. Known or suspected hepatocellular carcinoma or other hepatobiliary malignancies\n6. Use of the following medications (within 12 weeks prior to screening until the randomization \\[Day 1\\] visit): thiazolidinediones, fibrates, OCA, methotrexate, budesonide, and other systemic corticosteroids (equivalent to prednisone dose \\>10 mg); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, and nitrofurantoin); any other newly approved treatments for PBC (eg, elafibranor, seladelpar)\n7. Has elevated baseline ALT, AST, or ALP values; ALT, AST, or ALP values increasing by \\>50% on Visit 2 compared to Visit 1\n8. Has any of the following laboratory values:\n\n   i. TB \\>5 × ULN ii. Platelets \\\u003C50 × 10\\^9\u002FL iii. Albumin \\\u003C2.8 g\u002FdL iv. ALP \\>10 × ULN v. Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73m\\^2 vi. ALT or AST \\>5 × ULN vii. International normalized ratio (INR) \\>1.7 in the absence of anticoagulant therapy viii. CPK \\> 2x ULN\n9. Has participated in another interventional clinical study and received any other investigational medication or medical device within 30 days or 5 half lives, whichever is longer, prior to screening\n10. Has a history of malignancy in the past 5 years and\u002For active neoplasm, which may diminish life expectancy (except resolved superficial nonmelanoma skin cancer, carcinomas in situ, or other stable, relatively benign conditions prior to screening)\n11. Has a known allergy, hypersensitivity, or intolerance to saroglitazar or any of the formulation ingredients\n12. Pregnancy-related exclusions, including the following:\n\n    i. If a female, who is pregnant (including a positive pregnancy test at screening), breastfeeding, intends to become pregnant, or is a woman of childbearing potential and not agreeing to use adequate contraceptive methods for the duration of the study and for at least 1 month after receiving the last dose of the IP ii. Male participants with WOCBP partners and female participants must avoid pregnancy either by true abstinence or the use of acceptable, effective contraceptive measures for the duration of the study and for at least 1 month after receiving the last dose of the IP\n13. Has a history or other evidence of severe illness or any other conditions, including cardiovascular, endocrine, hematological, gastrointestinal, neurological, or psychiatric disease, that, in the opinion of the investigator, would make the participant unsuitable for the study","ALL","18 Years",{"count":20,"type":21},386,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)",[27],"Primary Biliary Cholangitis",[29,27,30,31],"Saroglitazar Magnesium","PBC","clinical outcome","RECRUITING","2026-07-31",{"date":35,"type":36},"2026-08-04","ACTUAL",{"date":38,"type":36},"2026-03-24",{"date":40,"type":21},"2032-11",{"name":42,"class":43},"Zydus Therapeutics Inc.","INDUSTRY",3,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":49,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100594775","phase-2-usnoflast-neuromuscular-investigation-for-treatment-efficacy-in-amyotrophic-lateral-sclerosis-100594775","NCT07023835","Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis","A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Usnoflast Administered to Adult Subjects With ALS","UNITE-ALS","Inclusion Criteria:\n\n* Diagnosis of probable or definite Amyotrophic lateral sclerosis, according to the revised version of the El Escorial World Federation of Neurology criteria\n* Time since onset of first symptom of Amyotrophic lateral sclerosis ≤24 months. Date of Amyotrophic lateral sclerosis symptom onset. For the purposes of this study, the date of symptom onset will be defined as the date the subject first had symptoms of their disease, i.e., limb weakness, dysarthria, dysphagia, shortness of breath, or fasciculations, from the screening visit.\n* Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised score of ≥35 at screening.\n* Slow vital capacity: ≥60% of predicted capacity at the screening visit.\n* Be able to swallow capsules.\n* Either not currently receiving riluzole\u002Fsodium phenylbutyrate and taurursodiol\u002Ftofersen or on a stable dose of riluzole\u002Fsodium phenylbutyrate and taurursodiol\u002Ftofersen for at least 4 weeks before the screening visit. Subjects receiving riluzole\u002Fsodium phenylbutyrate and taurursodiol\u002Ftofersen are expected to remain on the same dose throughout the duration of the study.\n* Either not currently receiving edaravone or on edaravone treatment. Subjects receiving edaravone must have completed at least 1 cycle of treatment before the screening visit and are expected to continue with a stable dose of edaravone treatment throughout the duration of the study.\n* Capable of providing informed consent and complying with study procedures in the opinion of the investigator\n\nExclusion Criteria:\n\n* Presence of unstable psychiatric disease, cognitive impairment, dementia, or substance abuse that would impair the ability of the subject to provide informed consent, in the opinion of the investigator.\n* Serious illness (e.g., pneumonia, septicemia) within 4 weeks of the screening visit; infection requiring hospitalization or treatment with intravenous antibiotics, antivirals, or antifungals within 4 weeks of screening; chronic bacterial infection (such as tuberculosis) deemed unacceptable as per the judgment of the investigator.\n* Active herpes zoster infection within 2 months prior to the screening visit.\n* Any medical condition that promotes suicidal attempt or behavior within 6 months prior to the screening visit and in the opinion of the investigator might interfere with subject's participation in the study or is a risk for a suicide attempt.\n* History of unstable or severe cardiac, pulmonary, oncological, hepatic, or renal disease or active cancer or another medically significant illness other than Amyotrophic lateral sclerosis, precluding safe participation of subject in this study in the opinion of the investigator.\n* Known allergy, sensitivity, or intolerance to Investigational product or excipients.\n* Subjects who have taken concomitant medications that are substrates of drug metaboliz-ing enzymes (Cytochrome P450 1A2 and\u002For Cytochrome P450 2B6) within 7 days or 5 half-lives of the medication (whichever is longer) before the first dose of Investigational product and throughout the study.\n* Use of any steroids, colchicine, or anti-IL-1 inhibitors within 7 days or 5 half-lives of the medication (whichever is longer) prior to the first dose of Investigational product administration.\n* Use of any investigational drug concurrently or within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of Investigational product administration.\n* Any clinically significant condition and\u002For laboratory significant value that would prevent the subject from participating in the study in the opinion of the investigator.\n* Received a live vaccine within 14 days before the screening visit or planning to receive during the study duration.\n* Subjects who have received stem cell or gene therapy for Amyotrophic lateral sclerosis at any time in the past.\n* Following laboratory test values at screening:\n\n  1. Alanine aminotransferase or Aspartate aminotransferase values \\>3.0 × Upper Limit of Normal\n  2. Bilirubin \\>1.5 × Upper Limit of Normal unless the subject has documented Gilbert's syndrome (isolated bilirubin \\>1.5 × Upper Limit of Normal is acceptable if bilirubin is fractionated, and direct bilirubin is \\\u003C35%)\n  3. Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m2\n* For those participating in the optional Cerebrospinal fluid collection, contraindications to lumbar puncture including but not limited to lumbar scoliosis, coagulopathy, infection at site of puncture, or use of anticoagulants.\n* Subjects with history of epilepsy within 6 months of screening visit.\n* Surgery within last 3 months or planned major surgery within next 3 months from the date of screening (other than minor cosmetic surgery and minor dental surgery).\n* Use or intended use of any medications\u002Fproducts known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 4 weeks of screening and up to end of study. Use of such medication will be considered on a case-by-case basis as per the opinion of the investigator and\u002For independent medical monitor.\n* Receiving an elemental diet or parenteral nutrition.\n* Received blood transfusion within 3 months prior to screening.\n* Subjects with Human immunodeficiency virus, hepatitis B, hepatitis C, coronary artery disease, or active gastrointestinal condition that might interfere with drug absorption.\n* Inability to be venipunctured or those not able to tolerate venous puncture.\n* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of employees of investigator or the investigator.\n* Any condition not mentioned in any of above criteria that, as per the investigator, would hinder participation of the subject in the study. This may include, but not limited to, considerations of safety, compliance, or other factors that could impact the integrity of the study or the well-being of the subject.\n* If female, breastfeeding, known to be pregnant, planning to become pregnant during the study, or of child-bearing potential and unwilling to use effective contraception during the study and for at least 1 month after administration of last dose of Investigational product. If male of reproductive capacity, unwilling to use effective contraception during the study and for at least 1 month after administration of last dose of Investigational product.\n\nFor Open Label Extension\n\nInclusion Criteria:\n\n* Completion in the randomized, double blind Usnoflast study (main study).\n* Subjects who elect to continue treatment after completion of Usnoflast phase 2b study must enrol in the OLE within 28 days of the completion of Week 36 visit of the main study.\n* Provide a new informed consent to enter the OLE phase.\n\nExclusion Criteria:\n\n* Discontinued IP prematurely in the double-blind phase of the study for reasons other than tracheostomy or permanent-assisted ventilation.\n* Treatment with or use of any restricted medications.\n* Any ongoing AE that, in the opinion of the site investigator, is clear contraindication to the IP.\n* Unstable cardiac or other life-threatening disease emergent during the randomized, double-blind study\n* Any major medical history or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study.\n* If female, breastfeeding, known to be pregnant, planning to become pregnant during the study, or of child-bearing potential and unwilling to use effective contraception during the study and for at least 1 month after administration of last dose of IP. If male of reproductive capacity, unwilling to use effective contraception during the study and for at least 1 month after administration of last dose of IP.",{"count":54,"type":21},240,[56],"PHASE2",[58],"Amyotrophic Lateral Sclerosis (ALS)",[60,61,62],"Amyotrophic Lateral Sclerosis,","ALS","Usnoflast","2026-07-24",{"date":65,"type":36},"2026-07-28",{"date":67,"type":36},"2025-09-17",{"date":69,"type":21},"2028-10",{"name":42,"class":43},17,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":93,"locationsCount":94},"100579535","phase-1-evaluate-pk--safety-of-saroglitazar-in-subjects-with-moderate-hepatic-impairment-due-to-cholestatic-liver-disease-100579535","NCT06825559","Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease","A Phase 1, Open-label, Single Arm Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Saroglitazar Magnesium Dosed on Alternate Days in Subjects Having Moderate Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease","Inclusion Criteria:\n\n1. Male and\u002For female aged 18 to 80 years (both inclusive) at the time of signing the ICF.\n2. Body mass index within the range 18.0 to 48.0 kg\u002Fm2 (inclusive) at screening.\n3. Ability to swallow and retain oral medication.\n4. Subjects having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease having Child-Pugh Turcotte score 7 to 9. If the hepatic impairment classification for the subject is not the same at screening and Day -1, enrolment of the subject into a hepatic category group will be at the discretion of the investigator.\n5. Laboratory test values must be clinically acceptable to the investigator and meet all the following parameters at screening:\n\n   Alkaline Phosphatase \\> upper limit of normal Alanine aminotransferase\u002FAspartate aminotransferase value ≤ 10 × upper limit of normal Absolute neutrophil count ≥ 750\u002Fmm3 Platelets ≥ 25,000\u002Fmm3 Hemoglobin ≥ 8 g\u002FdL α-fetoprotein \\\u003C50 ng\u002FmL or 50-80 ng\u002FmL with negative imaging study (Ultrasound \\[US\\], computed tomography scan \\[CT\\], Magnetic Resonance Imaging \\[MRI\\]). Imaging study that excluded presence of liver cancer (US in the preceding 6 months and CT or MRI in the preceding 1 year)\n6. Must provide written informed consent and agree to comply with the trial protocol.\n\nExclusion Criteria:\n\n1. Any significant or unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the investigator\n2. History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e., basal cell or squamous cell carcinoma).\n3. History of stomach or intestinal surgery or resection within 6 months of screening that would potentially alter absorption and\u002For excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).\n4. The history of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the investigator.\n5. Any major surgery within 3 months of screening.\n6. Donation of blood or blood products within 3 months of screening.\n7. Active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within 2 weeks of screening.\n8. Receiving or has received any investigational drug within 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium.\n9. Estimated glomerular filtration rate (\\\u003C45 mL\u002Fmin\u002F1.73 m2 by CKD-EPI 2021 formula at screening.\n10. Any individual with poor peripheral venous access.\n11. Receipt of blood products within 1 month of check in.\n12. Human immunodeficiency virus type 1 antibody positive at screening.\n13. Other known causes of liver disease, such as non-alcoholic steatohepatitis , alcoholic steatohepatitis, autoimmune hepatitis, or acute or chronic viral hepatitis (including Hepatitis B and C) as determined by the investigator and subject's medical records.\n14. Subjects who have had a change in hepatic disease status within 30 days of screening, as documented by the subject's medical history and deemed clinically significant by the investigator.\n15. Subjects having - History of gastrointestinal bleeding within 1 month of screening. Current functioning organ transplant. Evidence of severe ascites requiring frequent paracentesis in the opinion of the investigator.\n16. Pregnancy-related exclusions, including:\n\nPregnant\u002Flactating female (including positive pregnancy test at screening) Pregnancy should be avoided by male and female subjects either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study treatment.","80 Years",{"count":81,"type":21},6,[83],"PHASE1","Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease",[86],"Cholestatic Liver Disease",[29,27,30,88],"Pharmacokinetics",{"date":65,"type":36},{"date":91,"type":36},"2025-08-05",{"date":33,"type":21},{"name":42,"class":43},1,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":115,"locationsCount":94},"100442753","phase-1-hepatic-impairment-with-cirrhosis-due-to-cholestatic-liver-disease-100442753","NCT05045482","Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease","A Phase 1, Open-Label Extension Groups Study in Subjects Having Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease","Inclusion Criteria:\n\nFor all subjects:\n\n1. Ability to comprehend and willingness to sign a written ICF for the study.\n2. Male or female aged 18 to 80 years (inclusive) at the time of signing the ICF.\n3. Body mass index within the range 18.0 to 48.0 kg\u002Fm2 (inclusive) at screening.\n4. Females must be non-pregnant, non-lactating and of non-childbearing potential or using highly efficient contraception for the full duration of the study.\n5. Females of child-bearing potential and males must agree to use contraception for the full duration of the study.\n6. Ability to swallow and retain oral medication.\n\n   For Subjects in Groups 8 and 9 (Hepatic impairment group but with cirrhosis from cholestatic liver disease):\n7. Participants having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease in Groups 8 and 9 will be classified in sub groups at screening based on CPT score. If the hepatic impairment classification for the subject is not the same at screening and Day -1, enrolment of the subject into a hepatic category group will be at the discretion of the hepatology Investigator.\n8. Laboratory test values for hepatic impairment subjects Groups 8 (8A, 8B, 8C) and 9 (9A, 9B, 9C) must be clinically acceptable to the Investigator and meet all the following parameters at Screening:\n\n   1. ALT\u002FAST value ≤ 10 × upper limit of normal (ULN)\n   2. Absolute neutrophil count (ANC) ≥ 750\u002Fmm3\n   3. Platelets ≥ 25,000\u002Fmm3\n   4. Hemoglobin ≥ 8 g\u002FdL\n   5. α-fetoprotein \\\u003C 50 ng\u002FmL or 50-80 ng\u002FmL with negative imaging study (US, CT, MRI).\n\n   For Subjects in Groups 8D and 9D (normal hepatic function groups):\n9. Subjects should be in good health as determined by no clinically significant findings in the medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), or laboratory examinations at Screening or Check-in.\n10. Laboratory test values within normal limits or considered not clinically significant by the Investigator for subjects with normal hepatic function including ALT\u002FAST \\\u003C 1.2 × ULN at screening.\n\nExclusion Criteria:\n\nFor all subjects:\n\n1. Any significant, unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the Investigator or designee.\n2. History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e. basal cell or squamous cell carcinoma).\n3. History of stomach or intestinal surgery or resection within the six months prior to screening that would potentially alter absorption and\u002For excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).\n4. History of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the Investigator.\n5. Any major surgery within 3 months of screening.\n6. Donation of blood or blood products within 3 months prior to screening.\n7. Current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within the two weeks prior to screening.\n8. Use or intend to use any medications\u002Fproducts known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 21 days prior to screening, unless deemed acceptable by the Investigator.\n9. Receiving or has received any investigational drug within the 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium.\n10. Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73m2 by modification of diet in renal disease (MDRD) formula at screening.\n11. Positive alcohol breath test at the time of check-in or those subjects who have current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance or subject safety.\n12. Positive test for drugs of abuse at screening or admission. Subjects with a positive test based on a prescribed medication may be enrolled.\n13. Any subject with poor peripheral venous access\n14. Receipt of blood products within 1 month prior to check in.\n15. Human immunodeficiency virus (HIV) type 1 antibody positive at screening for all groups.\n\n    For Subjects in Groups 8 and 9 (Hepatic impairment group but with cirrhosis from cholestatic liver disease):\n16. Other known cause of liver disease such as NASH, alcoholic steatohepatitis (ASH), autoimmune hepatitis, or acute or chronic viral hepatitis as determined by the Investigator and subject's medical records.\n17. Subjects who have had a change in hepatic disease status within 30 days of screening, as documented by the participant's medical history and deemed clinically significant by the Investigator.\n18. Subjects having -\n\n    1. History of gastrointestinal bleeding within 1 month prior to screening.\n    2. Current functioning organ transplant.\n    3. Evidence of severe ascites requiring frequent paracentesis in the opinion of investigator.\n19. Subjects who use or intend to use any over the counter (vitamins, minerals, and phytotherapeutic\u002Fherbal\u002Fplant-derived preparations) or prescription medications within 30 days or 5 half-lives (whichever is longer) prior to enrolment, with the exception of hormone replacement therapy and therapies for hepatic disease and treatments of associated disorders that have been stable for at least 30 days prior to screening and until Day 1, unless deemed acceptable by the Investigator (or designee).\n\n    For Subjects in Group 8A (Mild hepatic impairment group) and 8B (Moderate impairment group)\n20. Total bilirubin \\> 5×ULN\n\n    For Control with Normal Hepatic Function:\n21. Subjects who have taken any prescription medications or over-the-counter medications, including herbal products, within 14 days prior to start of study drug dosing, with the exception of vitamins, acetaminophen, hormonal contraceptive medications and\u002For any other over-the-counter product approved by the Investigator.",true,{"count":104,"type":21},30,[83],"A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease",[108,109,86],"Hepatic Impairment","Cirrhosis",[108,29,109,86],{"date":65,"type":36},{"date":113,"type":36},"2021-10-21",{"date":33,"type":21},{"name":42,"class":43},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":4},"100625595","phase-3-study-of-saroglitazar-magnesium-for-pbc-patients-with-incomplete-response-or-intolerant-to-udca-therapy-100625595","NCT07424677","Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy","A Double-blind, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium on Normalization of Alkaline Phosphatase Levels in Patients With Primary Biliary Cholangitis and an Incomplete Response or Intolerance to Ursodeoxycholic Acid","EPICS-IV","Inclusion Criteria:\n\n1. Adults between 18 and 80 years of age (both inclusive at screening)\n2. History of confirmed Primary Biliary Cholangitis diagnosis\n3. Ursodeoxycholic acid treatment for at least 12 months and a stable dose for at least 6 months prior to first screening visit OR intolerant to Ursodeoxycholic acid (last dose of Ursodeoxycholic acid at least 3 months prior to first screening visit).\n4. Average Alkaline Phosphatase at both screening Visits 1 and 2: \\> 1× Upper Limit of Normal and \\\u003C 1.67× Upper Limit of Normal, and \\\u003C 30% variance between both levels\n5. Total bilirubin ≤ 2 x Upper Limit of Normal at screening (Visit 1), unless there is a prior diagnosis of Gilbert's syndrome. For participants with Gilbert's syndrome, direct bilirubin is to be ≤ 2 x Upper Limit of Normal at screening (Visit 1).\n6. Must have given written informed consent (signed and dated).\n\nExclusion Criteria:\n\n1. Consumption of 14 or more standard alcohol drinks per week if male and 7 or more standard alcohol drink per week if female for at least 3 consecutive months (i.e., 12 consecutive weeks) within 5 years before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits\u002Fhard liquor).\n2. History or presence of other concomitant liver diseases at screening\n3. Cirrhosis with complications, including history or presence of the following: spontaneous bacterial peritonitis, hepatocellular carcinoma, ascites requiring treatment, encephalopathy, known large esophageal varices, or history of variceal bleeding within one year prior to screening or history of hepatorenal syndrome.\n4. Medical conditions that may cause non-hepatic increases in Alkaline Phosphatase (e.g., Paget's disease) or which may diminish life expectancy to \\\u003C 2 years, including known cancers.\n5. Use of obeticholic acid, thiazolidinediones, fibrates (i.e. fenofibrate, bezafibrate, pemafibrate), other Peroxisome Proliferator-Activated Receptor agonists (i.e., seladelpar, elafibranor, lanifibranor), azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, systemic corticosteroids (equivalent to prednisone dose more than 10 mg per day); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin) (within 12 weeks prior to screening).\n6. History of bowel surgery (gastrointestinal \\[bariatric\\] surgery in the preceding 1 year or undergoing evaluation for gastrointestinal surgery (bariatric surgery for obesity, extensive small-bowel resection) or orthotopic liver transplant or listed for orthotopic liver transplant.\n7. Type 1 diabetes mellitus.\n8. Unstable cardiovascular disease\n9. History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, coagulation disorders, or screening blood tests that, in the opinion of the Investigator, indicate clinically significant altered coagulability (e.g., Prothrombin Time, International Normalized Ratio, Activated partial thromboplastin time) at screening.\n10. An uncontrolled thyroid disorder\n11. History of myopathies or evidence of active muscle disease demonstrated by Creatine Phosphokinase ≥ 5 x Upper Limit of Normal at screening.\n12. For subjects with elevated baseline Alanine Aminotransferase or Aspartate Aminotransferase; Alanine Aminotransferase or Aspartate Aminotransferase exceeding by more than 50% on Visit 2 compared to Visit 1.\n13. Any of the following laboratory values at screening:\n\n    1. Platelets \\\u003C 100 × 10\\^9\u002FL\n    2. Albumin \\\u003C 3.5 g\u002FdL\n    3. Estimated Glomerular Filtration Rate \\\u003C 45 mL\u002Fmin\u002F1.73 m\\^2\n    4. Alanine Aminotransferase or Aspartate Aminotransferase \\> 250 U\u002FL\n    5. International Normalized Ratio greater than or equal to 1.7. However, participants with an International Normalized Ratio of 1.7 or above may be included if the elevated International Normalized Ratio is not attributable to liver disease.\n14. Participation in another interventional clinical study and receipt of any other investigational medication (within 12 weeks prior to randomization up to the end of the study).\n15. History of malignancy in the past 5 years and\u002For active neoplasm except resolved superficial non-melanoma skin cancer.\n16. Contraindications to Saroglitazar Magnesium or has any conditions affecting the ability to evaluate the effects of Saroglitazar Magnesium.\n17. Known allergy, sensitivity, or intolerance to the study medication, comparator, or formulation ingredients.\n18. Pregnancy-related exclusions, including the following:\n\n    1. Pregnant\u002Flactating female (including positive pregnancy test at screening).\n    2. Pregnancy should be avoided by male and female participants either by true abstinence or the use of acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study treatment.\n19. History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as poorly controlled psychiatric disease, Human Immunodeficiency Virus, coronary artery disease, or active gastrointestinal conditions that might interfere with drug absorption).\n20. Cirrhosis with Child-Pugh-Turcotte Class B or C having a score of 7 or above at screening.\n21. Participants with Model for End Stage Liver Disease 3.0 score of 12 or above. For participants on anticoagulation medication, baseline International Normalized Ratio determination for Model for End Stage Liver Disease score calculation should take anticoagulant use into account.\n22. Initiation or dose adjustment of anti-pruritic drugs (e.g., cholestyramine, naltrexone, rifampin, sertraline, or any investigational therapeutic) within 1 month prior to screening and till randomization.",{"count":125,"type":21},89,[24],"Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy",[27],[27,29,30],"NOT_YET_RECRUITING","2026-05-11",{"date":133,"type":36},"2026-05-12",{"date":135,"type":21},"2026-06",{"date":137,"type":21},"2028-11",{"name":42,"class":43},""]