[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatic-insufficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatic-insufficiency":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,45,69,95,125,146,168],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100635960","phase-1-a-study-to-assess-the-safety-and-pharmacokinetics-of-incb123667-when-administered-orally-to-adult-participants-with-moderate-or-severe-hepatic-impairment-100635960",false,"NCT07559474","A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment","A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment","Inclusion Criteria:\n\n* Ability to comprehend and willingness to sign a written ICF for the study.\n* Aged 18 to 80 years, inclusive, at the time of signing the ICF.\n* Moderate or severe hepatic impairment based on CP score.\n* Medical findings consistent with the degree of hepatic dysfunction, determined by medical history, physical examination, vital sign measurements, 12-lead ECGs, and clinical laboratory determinations at screening or check-in (as applicable). Participants with abnormal findings considered not clinically significant by the medical monitor or investigator are eligible.\n* Body mass index of 18.0 to 43.0 kg\u002Fm2 (inclusive).\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* Participants who have a current, functioning organ transplant or are on the national transplant list and expected to receive a transplant within 3 months.\n* Tobacco or nicotine-containing product use of \\> 10 cigarettes per day within 1 month before screening.\n* Participants who had a change in disease status within 30 days before screening, as documented by the participant's medical history, that is deemed clinically significant by the investigator.\n* Participants who have a history of paracentesis within 2 months prior to check-in.\n* Participants who required new medication or an increase in dose for hepatic encephalopathy within 3 months prior to check-in.\n* Participants who have a history of unstable diabetes mellitus (as evidenced by hemoglobin A1c ≥ 10.0%). Medications for treatment of diabetes mellitus must be reviewed and approved by the investigator and medical monitor. Participants who have a portal systemic shunt. Up to 3 participants with transjugular intrahepatic portosystemic shunt may be included.\n* Participants who had esophageal banding within 3 months prior to check-in or required any other treatment for gastrointestinal bleeding within 6 months prior to check-in.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","ALL","18 Years","80 Years",{"count":20,"type":21},16,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with moderate or severe hepatic impairment.",[27,28],"Hepatic Insufficiency","Liver Diseases",[30,31],"hepatic impairment","liver impairment (moderate and severe)","RECRUITING","2026-06-12",{"date":35,"type":36},"2026-06-16","ACTUAL",{"date":38,"type":36},"2026-05-27",{"date":40,"type":21},"2027-04-13",{"name":42,"class":43},"Incyte Corporation","INDUSTRY",4,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100623840","phase-1-a-study-of-eloralintide-ly3841136-in-participants-with-different-levels-of-liver-damage-and-in-participants-with-healthy-livers-100623840","NCT07401862","A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers.","A Phase 1, Multicenter, Open-Label, Parallel-Design Study to Assess the Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Eloralintide (LY3841136) in Participants With Mild, Moderate, or Severe Hepatic Impairment and Participants With Normal Hepatic Function","Inclusion Criteria:\n\n* Have a body weight of 55 kilograms (kg) or more and body mass index between 19.0 and 40.0 kilograms per square meter (kg\u002Fm²), inclusive\n\nGroup 1\n\n* Are healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening\n\nGroups 2 through 4\n\n* Have hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment who are considered acceptable for participation in this study by the investigator. Participants must have a diagnosis of chronic hepatic impairment of greater than 6 months per physician diagnosis and standard-of-care practice, with no clinically significant changes in the opinion of the investigator within 15 days prior to screening\n\nParticipants with hepatic impairment may have stable baseline medical conditions for which neither the condition nor treatments received would negatively impact the health of the participant or study conduct\n\nExclusion Criteria:\n\n* Have a history or presence of chronic or acute pancreatitis or elevation in serum amylase or lipase greater than 1.5 × upper limit of normal (ULN)\n* Are pregnant or intend to become pregnant or to breastfeed during the study\n\nGroup 1\n\n* Have liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 1.5 × ULN or total bilirubin (TBL) greater than 1.5 × ULN at screening\n* Have a current infection with hepatitis B virus (HBV), that is,\n\n  * if hepatitis B surface antigen (HBsAg) is positive, the participant is excluded, or\n  * if HBsAg is negative and anti-Hepatitis B core antibody (HBc) is positive, further testing for HBV deoxyribonucleic acid (DNA) is required, and\n\n    * if the screening HBV DNA is positive, the participant is excluded\n* Have a current infection with hepatitis C virus (HCV), that is,\n\n  * if anti-HCV is positive, a test for circulating HCV ribonucleic acid (RNA) is required, and\n  * if HCV RNA test is positive, the participant is excluded\n\nGroups 2, 3, and 4\n\n* Have presence of active portal shunt or transjugular intrahepatic portosystemic shunt\n* Require paracentesis more often than 2 times per month or are expected to require paracentesis during the study\n* Have evidence of spontaneous bacterial peritonitis within 6 months of screening\n* Have had variceal bleeding within 3 months of screening. If the participant has undergone a successful banding procedure, they may participate in the study providing at least 1 month has passed after the banding procedure at the time of screening\n* Show presence of hepatocellular carcinoma\n* Have hepatic encephalopathy of Grade 2 or higher\n* Have TBL greater than 15 milligrams per deciliter (mg\u002FdL)\n* Have ALT greater than or equal to 6 × ULN",true,"85 Years",{"count":55,"type":21},36,[24],"The main purpose of this study is to evaluate how a medicine, LY3841136, works in participants with different levels of liver damage and in participants with healthy liver. The researchers want to see how the medicine is absorbed and used by the body, and if it causes any side effects, in participants with mild, moderate, or severe liver damage, as well as in participants with normal liver function.\n\nFor each participant, the study will last about 14 weeks, which will include a stay at the clinical research unit for 5 nights.",[27],"2026-06-03",{"date":61,"type":36},"2026-06-04",{"date":63,"type":36},"2026-02-10",{"date":65,"type":21},"2027-03",{"name":67,"class":43},"Eli Lilly and Company",3,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100619520","phase-4-a-study-of-the-pharmacokinetics-and-safety-of-anaprazole-sodium-in-special-populations-100619520","NCT07345689","A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations","A Study to Evaluate the Pharmacokinetics and Safety of Anaprazole Sodium in Subjects With Hepatic or Renal Impairment and in Elderly Subjects","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form before any study-related activities commence, demonstrate an understanding of the trial procedures and methodology, and be willing to strictly adhere to the clinical trial protocol for study completion;\n2. Subjects (including their partners) must agree to have no plans for conception from screening until 6 months after the last dose of the investigational drug and to voluntarily practice effective contraception during this period;\n3. Aged 18 to 70 years (inclusive) at the time of signing informed consent, either male or female. For the elderly group, subjects must be aged 65 years or older (inclusive);\n4. Body mass index (BMI) between 18 and 32 kg\u002Fm² (inclusive);\n5. Subjects in the healthy group should be matched as closely as possible to those in the hepatic impairment, renal impairment, and elderly groups in terms of gender and weight, and additionally matched for age with the hepatic and renal impairment groups;\n6. Subjects in the hepatic impairment group must also meet all of the following additional criteria:\n\n   Subjects with chronic liver injury due to primary liver diseases (e.g., hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.), classified as Child-Pugh Grade B hepatic insufficiency; Clinically diagnosed cirrhosis; eGFR \\> 59 mL\u002Fmin; Subjects are either those with a stable concomitant medication regimen (for hepatic impairment\u002Fcomplications\u002Fother diseases) for ≥2 weeks pre-dose not requiring anticipated adjustment (excluding, e.g., diuretics\u002Finsulin), or those not on such medications;\n7. Subjects in the renal impairment group must also meet all of the following additional criteria:\n\nDiagnosed with chronic kidney disease (CKD), defined as the presence of any marker of kidney damage or GFR \\\u003C 60 mL\u002Fmin for more than 3 months (evidence may include outpatient records, inpatient records, or laboratory reports); GFR must meet the following criteria: Moderate renal impairment (CKD Stage 3): 30-59 mL\u002Fmin (inclusive); Severe renal impairment (CKD Stage 4): 15-29 mL\u002Fmin (inclusive); Note: Staging will be determined solely based on the second scheduled GFR measurement during the screening period; Renal function must be stable, defined as meeting either of the following criteria based on two GFR measurements taken prior to dosing (with at least a 3-day interval between measurements): Both results fall within the same CKD stage; or the fluctuation between the two GFR results is \\\u003C10% (calculated as: \\[(Second result - First result) \u002F First result\\] × 100%).\n\nExclusion Criteria:\n\n1. Subjects with a history of hypersensitivity or allergic constitution (including severe drug allergies or drug hypersensitivity reactions), or with a known allergy to the investigational drug or any of its excipients;\n2. QTcF (male) \\> 470 ms, QTcF (female) \\> 480 ms;\n3. Uncontrolled hypertension, defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite antihypertensive therapy. This criterion does not apply to subjects in the healthy group;\n4. History of dysphagia or any gastrointestinal disorder that may affect drug absorption, including frequent nausea or vomiting due to any etiology;\n5. History of severe infection, trauma, gastrointestinal surgery, or other major surgery within 4 weeks prior to screening;\n6. Receipt of any vaccine within 14 days prior to screening, or intention to receive any vaccination during the course of the study;\n7. Donation or loss of blood ≥ 400 mL within 3 months prior to screening, or intention to donate blood during the study;\n8. Use of moderate or strong CYP3A4 inhibitors\u002Finducers within 2 weeks prior to screening, or planned concomitant use during the study; or use of CYP3A4-sensitive substrates within 2 weeks prior to screening or planned use during the study;\n9. Use of proton pump inhibitors (PPIs, e.g., rabeprazole, pantoprazole, esomeprazole) within 2 weeks prior to screening or planned concomitant use during the study; medications known to affect serum creatinine clearance (e.g., calcium dobesilate, trimethoprim\u002Fsulfamethoxazole, cimetidine); drugs prone to cause liver injury (e.g., non steroidal anti inflammatory drugs, antibiotics, antituberculosis agents, antifungals, glucocorticoids); or drugs with high plasma protein binding (e.g., warfarin, dicoumarol, diazepam, phenylbutazone, digitoxin);\n10. Consumption of special diets (including pitaya, mango, pomelo, and\u002For xanthine containing foods such as chocolate) within 2 weeks prior to dosing, and\u002For habitual excessive intake of tea, coffee, grapefruit\u002Fgrapefruit juice, or caffeinated beverages (average \\>8 cups per day, 200 mL per cup);\n11. History of excessive alcohol consumption, defined as \\>14 units per week on average, within the 3 months preceding screening (where 1 alcohol unit equals 360 mL of beer, 45 mL of 40% distilled spirits, or 150 mL of wine);\n12. Positive result on alcohol breath test or urine drug screening at screening;\n13. Average cigarette consumption of ≥10 cigarettes per day within 3 months prior to screening;\n14. History of drug abuse or substance misuse;\n15. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test;\n16. Intolerance to venipuncture or history of needle\u002Fphobia syncope;\n17. Use of any investigational drug within 3 months prior to screening or planned participation in another clinical trial during this study;\n18. Other conditions deemed by the investigator to compromise the subject's suitability for the study;\n\n    Healthy Subjects will be excluded if they meet any of the following criteria:\n19. History of hepatic impairment or renal impairment;\n20. Any clinically significant active or chronic disease affecting major organ systems (e.g., circulatory, endocrine, neurological, digestive, respiratory, hematologic, immunologic, psychiatric, or metabolic systems) at screening, or any other medical condition that could potentially confound the interpretation of study outcomes;\n21. Clinically significant abnormalities (as judged by the investigator) in physical examination, vital signs, laboratory tests, 12 lead ECG, abdominal ultrasound, or chest X ray;\n22. Positive screening result for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV antigen\u002Fantibody, or syphilis antibody;\n23. Administration of any prescription medication, non prescription drug, vitamin supplement, or herbal preparation within 14 days prior to screening;\n\n    Subjects in the hepatic impairment group will be excluded if they meet any of the following criteria:\n24. Subjects who present with any of the following conditions and are deemed by the investigator as unsuitable for this study will be excluded:\n\n    Prior liver transplantation; Diseases such as biliary cirrhosis or extrahepatic biliary obstruction;\n\n    Diagnosis of liver cancer or other malignant tumors, with the following exceptions:\n\n    Certain completely cured cancers after surgical resection, such as basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; Liver cancer patients who have received radical therapy with no recurrence; Liver cancer patients classified as BCLC stage 0. Acute liver failure; History of esophageal or gastric variceal bleeding within 3 months prior to screening;\n25. Laboratory test results at screening meeting any of the following criteria:\n\n    1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 × upper limit of normal (ULN);\n    2. Absolute neutrophil count \\\u003C 0.75 × 10⁹\u002FL;\n    3. Hemoglobin \\\u003C 80 g\u002FL;\n    4. Alpha fetoprotein (AFP) \\> 100 ng\u002FmL;\n    5. Platelet count \\\u003C 40 × 10⁹\u002FL; or any other clinically significant laboratory abnormality that, in the investigator's judgment, renders the subject unsuitable for the study;\n26. Positive screening result for HIV antigen\u002Fantibody; Positive syphilis antibody test result with a confirmatory positive rapid plasma reagin (RPR) test;\n27. In addition to the primary hepatic condition, subjects will be excluded if, at screening, they present with any other severe systemic disease-including but not limited to significant gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, immune, psychiatric, or cardiovascular\u002Fcerebrovascular disorders-that in the investigator's judgment would make them unsuitable for the study;\n\n    Subjects in the renal impairment group will be excluded if they meet any of the following criteria:\n28. Acute renal failure, prior kidney transplantation, or requirement for renal dialysis during the study;\n29. Subjects will be excluded if, in addition to chronic kidney disease and its complications, they have a history or current evidence of any other severe systemic disorder-including but not limited to significant gastrointestinal, respiratory, neurological, hematological, endocrine, oncological (except for completely resected in situ basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in situ of the breast), immunological, psychiatric, or cardiovascular\u002Fcerebrovascular disease-that, in the investigator's opinion, would make participation in the study inappropriate;\n30. ALT ≥ 2 × ULN, AST ≥ 2 × ULN; Serum total bilirubin \\> 1.5 × ULN; Albumin \\\u003C 30 g\u002FL; Absolute neutrophil count \\\u003C 1.3 × 10⁹\u002FL; Hemoglobin \\\u003C 80 g\u002FL; Platelet count \\\u003C 100 × 10⁹\u002FL; Any other clinically significant laboratory abnormality that, in the investigator's judgment, renders the subject unsuitable for the study;\n31. Congestive heart failure classified as New York Heart Association (NYHA) Class III or IV, or Left ventricular ejection fraction (LVEF) \\\u003C 50% at screening;\n32. Positive result for HIV antigen\u002Fantibody; Positive syphilis antibody test result, with a confirmatory positive rapid plasma reagin (RPR) test;\n\n    Elderly subjects will be excluded if they meet any of the following criteria:\n33. Subjects will be excluded if they have any other severe systemic disease at screening - including but not limited to significant gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, oncologic (except completely resected in situ basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast), immunologic, psychiatric, or cardiovascular\u002Fcerebrovascular disorders - and if, in the investigator's judgment, participation would be inappropriate;\n34. Fasting blood glucose \\> 7.0 mmol\u002FL;\n35. ALT ≥ 1.5 × ULN, AST ≥ 1.5 × ULN; Serum total bilirubin \\> 1.5 × ULN; Albumin \\\u003C 30 g\u002FL; Creatinine \\> 1.5 × ULN; Albumin \\\u003C 30 g\u002FL; Hemoglobin \\\u003C 100 g\u002FL; Platelet count \\\u003C 100 × 10⁹\u002FL; Any other clinically significant laboratory abnormality that, in the investigator's judgment, renders the subject unsuitable for the study;\n36. Positive screening result for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV antigen\u002Fantibody, or syphilis antibody.",{"count":77,"type":21},60,[79],"PHASE4","The objective of this study is to evaluate the pharmacokinetic profile and safety of anaprazole sodium in adult subjects, particularly including the elderly and those with renal or hepatic impairment.",[27,82,83],"Renal Insufficiency","Elderly","NOT_YET_RECRUITING","2026-01-07",{"date":87,"type":36},"2026-01-16",{"date":89,"type":21},"2026-01-30",{"date":91,"type":21},"2027-06-30",{"name":93,"class":43},"Xuanzhu Biopharmaceutical Co., Ltd.",1,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":94},"100619316","diagnosis-of-lymphohistiocytic-hemophagocytosis-in-intensive-care-100619316","NCT07343037","Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care","Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care: Relevance of the Hscore and Search for the Best Diagnostic Markers","SAMICU","Inclusion Criteria:\n\n* Adult patient (≥18 years old)\n* Patient admitted to the intensive care unit at Hautepierre Hospital, Strasbourg University Hospital, between January 1, 2014, and December 31, 2024\n* At least 3 biological signs of HLH:\n\n  * ferritin \\> 2000 ng\u002FmL\n  * triglycerides \\> 1.5 g\u002FL\n  * at least one cytopenia (leukocytes ≤ 5000 G\u002FL, platelets ≤ 110 G\u002FL, hemoglobin ≤ 9.2 g\u002FdL).\n\nExclusion Criteria:\n\nRefusal to participate in the study",{"count":104,"type":21},100,"OBSERVATIONAL","Patients with hepatocellular insufficiency and\u002For cirrhosis are at risk of developing invasive fungal infections, particularly in critical care settings.\n\nIn international recommendations, voriconazole is positioned as the first-line treatment for invasive aspergillosis. However, this molecule-and the azole class of antifungals-is associated with frequent hepatic toxicity. Available since 2018, isavuconazole appears to be better tolerated in patients without pre-existing liver dysfunction.\n\nThe aim of this study is to retrospectively evaluate the validity of the hscore in intensive care and resuscitation patients.",[27,108],"Cirrhosis, Liver",[27,108,110,111,112,113,114],"Lymphohistiocytic hemophagocytosis","Hepatocellular insufficiency","Invasive aspergillosis","Azole antifungals","Liver dysfunction.","2026-01-06",{"date":117,"type":36},"2026-01-15",{"date":119,"type":36},"2025-08-29",{"date":121,"type":21},"2026-08-29",{"name":123,"class":124},"University Hospital, Strasbourg, France","OTHER",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":68},"100605629","phase-1-a-study-of-the-pharmacokinetics-and-safety-of-ly3537031-in-participants-with-normal-liver-function-and-with-mild-moderate-or-severe-liver-impairment-100605629","NCT07165002","A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment","A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment","Inclusion Criteria:\n\n* Have a body weight of 55 kilogram (kg) or more and body mass index (BMI) between 19.0 and 40.0 kilogram per square meter (kg\u002Fm²), inclusive\n* Have no significant history of spontaneous or ethanol-induced hypoglycemia\n\nAdditional Inclusion Criteria for Participants Without Hepatic Impairment in Group 1:\n\n* Are healthy participants as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening\n* Have normal blood pressure (BP) and pulse rate, as determined by the investigator\n\nAdditional Inclusion Criteria for Participants with Mild to Severe Hepatic Impairment in Groups 2 through 4:\n\n* Participants with hepatic impairment classified as Child-Pugh score A, B, or C who are considered acceptable for participation in this study by the investigator. Participants must have a diagnosis of chronic hepatic impairment of greater than 6 months per physician diagnosis and standard-of-care practice, with no clinically significant changes, in the opinion of the investigator, within 15 days prior to screening\n* Clinical laboratory test results with deviations that are judged by the investigator to be compatible with the hepatic impairment of the participant, or of no additional clinical significance for this study. Abnormalities of serum glucose, serum lipids and triglycerides, urinary glucose, and urinary protein consistent with Type 2 Diabetes Mellitus (T2DM) are acceptable\n* Have a systolic BP less than 150 millimeters mercury (mmHg), a diastolic BP less than 90 mmHg, and a pulse rate greater than 50 but less than 100 beats per minute\n* If participants have T2DM, they must have a hemoglobin A1c measurement equal to or less than 11.5% at the screening visit\n\nExclusion Criteria:\n\n* Have significant history of or current cardiovascular, respiratory, hepatic (hepatic applies to Group 1 only), renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data\n* Have a history of atopy; that is, severe or multiple allergic manifestations, or clinically significant multiple or severe drug allergies, or hyperesthesia, or severe posttreatment hypersensitivity reactions, or have known allergies to LY3537031, or related compounds\n* Have undergone any form of bariatric surgery\n* Have a history of or current acute or chronic pancreatitis, or elevation in serum lipase or amylase or both greater than 1.5× upper limits of normal (ULN)",{"count":133,"type":21},32,[24],"The purpose of this study is to measure how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function and in healthy participants with normal liver function. The safety and tolerability of LY3537031 will also be evaluated. The study drug will be administered subcutaneously (SC) (under the skin).",[137,27],"Healthy","2025-12-03",{"date":140,"type":36},"2025-12-04",{"date":142,"type":36},"2025-10-20",{"date":144,"type":21},"2026-08",{"name":67,"class":43},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":44},"100582083","phase-1-a-study-to-investigate-pharmacokinetics-pk-and-safety-of-a-single-dose-of-mavorixafor-in-participants-with-hepatic-impairment-hi-compared-to-matched-healthy-volunteers-with-normal-hepatic-function-100582083","NCT06858696","A Study to Investigate Pharmacokinetics (PK) and Safety of a Single Dose of Mavorixafor in Participants With Hepatic Impairment (HI) Compared to Matched Healthy Volunteers With Normal Hepatic Function","An Open-label, Non-randomized Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of a Single Dose of Mavorixafor in Participants With Hepatic Impairment (HI) Compared to Matched Healthy Volunteers With Normal Hepatic Function","Key Inclusion Criteria:\n\n* Body weight is more than 50.0 kilograms (kg) with body mass index (BMI) between 18.0 and 40.0 kg\u002Fsquare meter (m\\^2) at the Screening Visit and at Day -1 Visit.\n* In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations.\n* Current non-smoker or light smoker, that is, no more than 10 cigarettes or 10 milligrams (mg) equivalent use of nicotine per day by e-vapor cigarette, pipe, cigar, chewing tobacco, nicotine patch, nicotine gum, and able and willing to refrain from smoking and tobacco use during the study.\n\nInclusion criteria applicable to participants with HI Only:\n\n* Aside from hepatic insufficiency, the participant is deemed by the Investigator to be sufficiently healthy for study participation, based upon medical history, physical examination, vital signs, and screening laboratory evaluations.\n* Documented chronic stable liver disease according to CP classification with diagnosis of HI due to parenchymal liver disease.\n* Currently on a stable medication regimen, defined as not starting new drug(s) or changing drug dose(s) within 28 days of the mavorixafor administration (Day 1).\n\nKey Exclusion Criteria:\n\n* Female participants\u002Fvolunteers who are breastfeeding or female participants\u002F volunteers with a positive pregnancy test at the Screening Visit or at Day -1.\n* History of allergy to mavorixafor excipients or drugs in a similar pharmacological class with mavorixafor.\n* Has an active malignancy or history (≤ 5 years prior to enrollment) of solid, metastatic, or hematologic malignancy.\n* A known history of positive serology or viral load for human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome.\n* Known active COVID-19 infection or a positive test within the local accepted clinical and governmental guidelines for a communicable window.\n* Positive hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb).\n* Positive hepatitis C antibody test result at screening.\n* Have received mavorixafor previously.\n* Has used an investigational drug within 30 days (or 5 half-lives whichever is longer) before the first dose of mavorixafor.\n\nAdditional exclusion criteria applicable to Volunteers with Normal Hepatic Function Only:\n\n* History or evidence of liver disease such as alcoholic liver disease, autoimmune hepatitis, hepatitis B, hepatitis C, primary biliary cirrhosis, primary sclerotic cholangitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug induced liver injury, and\u002For hepatocellular carcinoma.\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal, neurological, or psychiatric disorder.\n* Clinical laboratory test results must be strictly within the normal laboratory reference ranges for liver function and hematology, and for other parameters, deemed as not clinically significant by the Investigator.\n\nAdditional exclusion criteria applicable to participants with HI Only:\n\n* Clinically significant abnormal laboratory values at screening or Day -1, in the judgment of the Investigator.\n* History of liver transplant or currently in the top 5% of recipients on the transplant list.\n* Evidence of hepatorenal syndrome or abnormal serum creatinine levels (above upper limit for the local lab) and estimated glomerular filtration rate \\\u003C 60 milliliters (mL)\u002Fminute (min) or abnormal sodium and potassium levels.\n* New medication or a change in dose for hepatic encephalopathy within the 3 months prior to admission to the clinical site, unless approved by the Investigator and the study Medical Monitor.\n* Concurrent conditions that could interfere with safety and\u002For tolerability measurements.\n\nNOTE: Other protocol-defined inclusion and exclusion criteria may apply.","75 Years",{"count":155,"type":21},48,[24],"The purpose of this study is to measure the effect of HI on the PK, safety, and tolerability of a single dose of mavorixafor compared to matched healthy volunteers (HVs) with normal hepatic function.",[27],"2025-04-02",{"date":161,"type":36},"2025-04-03",{"date":163,"type":36},"2025-02-28",{"date":165,"type":21},"2026-04",{"name":167,"class":43},"X4 Pharmaceuticals",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":153,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":4},"100446479","phase-1-ulonivirine-mk-8507-in-participants-with-mild-or-moderate-hepatic-impairment-mk-8507-014-100446479","NCT05093972","Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)","An Open-Label, Single-Dose Clinical Study to Evaluate Pharmacokinetics of MK-8507 in Participants With Mild or Moderate Hepatic Impairment.","Inclusion Criteria:\n\nMild and Moderate HI (Panels A and B):\n\n* Has a diagnosis of chronic (\\>6 months), stable HI with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function)\n\nHealthy Controls (Panel C):\n\n* Is in good health\n\nAll Participants (Panels A to C):\n\n* Has a body mass index (BMI) ≥18.5 and ≤40 kg\u002Fm\\^2, inclusive\n* If male, uses contraception in accordance with local regulations\n* If female, is not pregnant or breastfeeding and one of the following applies: 1) is not a woman of childbearing potential (WOCBP), or 2) is a WOCBP and is abstinent\u002Fuses acceptable contraception, has a negative highly sensitive pregnancy test within 24 hours of receiving study intervention, and provides medical\u002Fmenstrual\u002Frecent sexual history for review by the investigator\n\nExclusion Criteria:\n\nMild and Moderate HI (Panels A and B):\n\n* Has a history of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study\n* Is not in sufficient health\n* Is institutionalized\u002Fmentally or legally incapacitated\n* Is positive for human immunodeficiency virus (HIV)-1 or HIV-2\n* Has received antiviral and\u002For immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start\n* Is taking medication for a chronic condition and has not been on a stable regimen for ≥ 1 month\n\nHealthy Controls (Panel C):\n\n* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases\n* Is mentally or legally incapacitated\n* Is positive for hepatitis B virus surface antigen (HBsAg), hepatitis C antibodies, HIV-1, or HIV-2\n* Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to first dose of study drug\n\nAll Participants (Panel A to C):\n\n* Has a history of cancer (malignancy)\n* Has a history of significant multiple and\u002For severe allergies\n* Has known hypersensitivity to the active substance or any of the excipients of the study drug\n* Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to Screening",{"count":176,"type":21},22,[24],"The purpose of this study is to evaluate pharmacokinetics (PK) and safety of a single oral dose of ulonivirine in participants with mild or moderate hepatic impairment (HI). It is hypothesized that the area under the plasma concentration-time curve from dosing to (extrapolated) infinity (AUC0-∞) in participants with mild or moderate HI is similar to that of healthy control participants.",[27],"2025-02-14",{"date":182,"type":36},"2025-02-18",{"date":184,"type":21},"2026-04-07",{"date":186,"type":21},"2026-09-10",{"name":188,"class":43},"Merck Sharp & Dohme LLC"]