[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634982":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":82,"collaborators":29,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":29,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":29,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":43,"whyStopped":29,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","Participants with severe hepatic impairment (CP Class C, score of 10 to 15).",[13,14],"Drug: AZD6234","Drug: AZD9550",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 2","Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Group 3","Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the participants with hepatic impairment.",[13,14],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","AZD6234","Single subcutaneous dose of AZD6234 in participants from all groups",[9,16,20],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"AZD9550","Single subcutaneous dose of AZD9550 in participants from all groups",[9,16,20],[35],{"name":36,"role":37,"phone":38,"phoneExt":29,"email":39},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[41,55,64,73],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":29},"Research Site","RECRUITING","Chandler","Arizona","85225","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-111.84125,33.30616,{"lat":53,"lon":52},{"facility":42,"status":43,"city":56,"state":57,"zip":58,"country":47,"countryCode":48,"cosmosGeoPoint":59,"geoPoint":63,"contacts":29},"Rialto","California","92377",{"type":50,"coordinates":60},[61,62],-117.37032,34.1064,{"lat":62,"lon":61},{"facility":42,"status":43,"city":65,"state":66,"zip":67,"country":47,"countryCode":48,"cosmosGeoPoint":68,"geoPoint":72,"contacts":29},"Miami Lakes","Florida","33014",{"type":50,"coordinates":69},[70,71],-80.30866,25.90871,{"lat":71,"lon":70},{"facility":42,"status":43,"city":74,"state":75,"zip":76,"country":47,"countryCode":48,"cosmosGeoPoint":77,"geoPoint":81,"contacts":29},"San Antonio","Texas","78215",{"type":50,"coordinates":78},[79,80],-98.49363,29.42412,{"lat":80,"lon":79},{"type":83,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100634982","phase-1-a-phase-i-study-to-investigate-the-effect-of-hepatic-impairment-of-azd9550-and-azd6234-100634982",false,"NCT07546760","A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234","A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD9550 and AZD6234","Inclusion Criteria\n\n1. Age 18-85 years at consent.\n2. Groups:\n\n   * Healthy controls: Medically healthy; no clinically significant findings in history, exam, labs, vitals, or 12 lead ECG (per investigator).\n   * Hepatic impairment: Chronic (≥6 months), stable; documented Child Pugh B (Group 2) or C (Group 1).\n3. Stable concomitant regimen ≥2 weeks before screening (Groups 1-2).\n4. T2DM allowed if HbA1c \\\u003C10% and no severe hypo\u002Fhyperglycaemia or hospitalisation within 6 months.\n5. Body weight ≥50 kg; BMI 18-42 kg\u002Fm².\n6. Sex assigned at birth (male\u002Ffemale); contraception per local regulations. Females of child bearing potential: negative pregnancy tests and condoms plus one highly effective method through 54 days post last dose. Males: condom use; no sperm donation through 54 days post last dose.\n7. Written informed consent; separate consent for optional genomics.\n\nExclusion Criteria\n\nHealthy controls only:\n\n1. Any clinically significant disease; Diabetes;\n2. lab values i) ALT\u002FAST\u002FALP \\>1.5×ULN; ii) WBC\u002Fplatelets \\\u003CLLN; iii) haemoglobin \\\u003C11.0 g\u002FdL (female) or \\\u003C12.0 g\u002FdL (male); aPTT or PT\u002FINR \\>1.2×ULN; iv) total bilirubin \\>1.5×ULN (or Gilbert's);\n3. abnormal resting vital signs i) SBP \\>150 or \\\u003C90 mmHg, ii) DBP \\>95 or \\\u003C50 mmHg, iii) pulse ≥100 or ≤45 bpm;\n4. QTcF \\>450 ms or clinically significant ECG abnormalities;\n5. severe allergy\u002Fhypersensitivity;\n6. major surgery within 30 days;\n7. pancreatitis or pancreatic enzymes \\>2×ULN;\n8. triglycerides \\>500 mg\u002FdL (5.6 mmol\u002FL);\n9. calcitonin \\>50 ng\u002FL (50 pg\u002FmL);\n10. severe vitamin D deficiency (\\\u003C12 ng\u002FmL, 30 nmol\u002FL);\n11. low corrected or ionised calcium;\n12. HIV positive; HBV surface\u002Fcore Ab or HCV Ab positive; drug\u002Falcohol abuse within 1 year.\n\n    Hepatically impaired only:\n13. Unstable medical\u002Fpsychological conditions or uncontrolled systemic disease;\n14. eGFR \\\u003C50 mL\u002Fmin\u002F1.73 m² (CKD EPI 2021);\n15. Abnormal resting vital signs i) SBP \\>160 or \\\u003C100 mmHg, ii) DBP \\>110 or \\\u003C65 mmHg, iii) pulse ≥100 or ≤50 bpm;\n16. platelets \\\u003C35×10⁹\u002FL; neutrophils \\\u003C1.2×10⁹\u002FL; haemoglobin \\\u003C85 g\u002FL; HbA1c ≥10%;\n17. oesophageal banding within 3 months or GI bleeding within 6 months;\n18. ascites requiring paracentesis and albumin ≤4 week intervals; paracentesis within 30 days;\n19. fluctuating\u002Fworsening hepatic function during screening; hepatocellular carcinoma;\n20. acute liver disease due to infection\u002Fdrug; hepatic impairment due to non liver disease;\n21. biliary obstruction or non parenchymal causes; hepatic encephalopathy Grade ≥2;\n22. functioning organ transplant or anticipated within 2 months; prior porto systemic shunt\u002FTIPS;\n23. QTcF \\>480 ms or clinically significant ECG abnormalities;\n24. pancreatitis or pancreatic enzymes \\>2×ULN;\n25. triglycerides \\>500 mg\u002FdL (5.6 mmol\u002FL); calcitonin \\>50 ng\u002FL (50 pg\u002FmL); severe vitamin D deficiency (\\\u003C12 ng\u002FmL, 30 nmol\u002FL); ionised calcium \\\u003CLLN;\n26. neoplastic disease within 10 years (except adequately treated BCC\u002FSCC or in situ cervical); MEN2 or medullary thyroid carcinoma (personal or first degree relative); significant gastric emptying abnormality;\n27. HIV positive; HBV surface\u002Fcore Ab or HCV Ab positive (may be included if HBV DNA or HCV RNA negative on follow up); drug\u002Falcohol abuse within 1 year.\n28. Exposure to a new chemical entity within 30 days or 5 half lives (whichever longer) before intervention; prior exposure to AZD9550 or AZD6234;\n\n    Prior\u002Fconcomitant therapy:\n\n    Healthy controls:\n29. use of prescription\u002Fnon prescription\u002Fsupplements within 7 days (or 14 days for enzyme inducers) or 5 half lives before intervention unless judged non interfering; current oral contraceptives or oestrogen HRT.\n\n    Hepatically impaired:\n30. prohibited-weight loss medicines (including GLP 1), agents causing significant weight gain (e.g., systemic glucocorticoids, antipsychotics), GLP 1 RAs for diabetes, QT prolonging\u002Fprokinetic agents, oral contraceptives for contraception; restricted-short systemic glucocorticoids (≤7 days), 5HT 3 antiemetics at lowest effective dose, combined oral contraceptives for non contraceptive indications. If diabetes develops and requires insulin\u002FSU\u002FGLP 1 RA, discontinue from study.\n\n    Other:\n31. prior enrolment in this study (screened without dosing permitted). Positive drugs of abuse and\u002For alcohol screen (except prescribed meds in hepatic impairment); recent blood products\u002Fdonation per protocol thresholds; employees or close relatives; vulnerable populations; unlikely to comply (investigator judgement).",true,"ALL","18 Years","85 Years",{"count":96,"type":97},28,"ESTIMATED","INTERVENTIONAL",[100],"PHASE1","The purpose of this study is to examine the safety and tolerability of AZD6234 and AZD9550 in participants with hepatic impairment and participants with normal hepatic function.",[103],"Hepatic Impairment",[105,106,107],"Moderate","Severe","Matched Healthy Controls","2026-06-02",{"date":110,"type":111},"2026-06-03","ACTUAL",{"date":113,"type":111},"2026-03-20",{"date":115,"type":97},"2027-02-04",{"name":5,"class":6},4]