A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234

Recruiting now · Phase 1

Conditions studied: Hepatic Impairment

In brief

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.

Key facts

Study ID

NCT07546760

Run by

AstraZeneca

People needed

28

Starts

2026-03-20

Expected to finish

2027-02-04

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18-85 years at consent.
• Groups:
• Healthy controls: Medically healthy; no clinically significant findings in history, exam, labs, vitals, or 12 lead ECG (per investigator).
• Hepatic impairment: Chronic (≥6 months), stable; documented Child Pugh B (Group 2) or C (Group 1).
• Stable concomitant regimen ≥2 weeks before screening (Groups 1-2).
• T2DM allowed if HbA1c <10% and no severe hypo/hyperglycaemia or hospitalisation within 6 months.
• Body weight ≥50 kg; BMI 18-42 kg/m².
• Sex assigned at birth (male/female); 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.
• Written informed consent; separate consent for optional genomics.

You may not qualify if…

• Healthy controls only:
• Any clinically significant disease; Diabetes;
• lab values i) ALT/AST/ALP >1.5×ULN; ii) WBC/platelets <LLN; iii) haemoglobin <11.0 g/dL (female) or <12.0 g/dL (male); aPTT or PT/INR >1.2×ULN; iv) total bilirubin >1.5×ULN (or Gilbert's);
• abnormal resting vital signs i) SBP >150 or <90 mmHg, ii) DBP >95 or <50 mmHg, iii) pulse ≥100 or ≤45 bpm;
• QTcF >450 ms or clinically significant ECG abnormalities;
• severe allergy/hypersensitivity;
• major surgery within 30 days;
• pancreatitis or pancreatic enzymes >2×ULN;
• triglycerides >500 mg/dL (5.6 mmol/L);
• calcitonin >50 ng/L (50 pg/mL);
• severe vitamin D deficiency (<12 ng/mL, 30 nmol/L);
• low corrected or ionised calcium;
• HIV positive; HBV surface/core Ab or HCV Ab positive; drug/alcohol abuse within 1 year.
• Hepatically impaired only:
• Unstable medical/psychological conditions or uncontrolled systemic disease;
• eGFR <50 mL/min/1.73 m² (CKD EPI 2021);
• Abnormal resting vital signs i) SBP >160 or <100 mmHg, ii) DBP >110 or <65 mmHg, iii) pulse ≥100 or ≤50 bpm;
• platelets <35×10⁹/L; neutrophils <1.2×10⁹/L; haemoglobin <85 g/L; HbA1c ≥10%;
• oesophageal banding within 3 months or GI bleeding within 6 months;
• ascites requiring paracentesis and albumin ≤4 week intervals; paracentesis within 30 days;
• fluctuating/worsening hepatic function during screening; hepatocellular carcinoma;
• acute liver disease due to infection/drug; hepatic impairment due to non liver disease;
• biliary obstruction or non parenchymal causes; hepatic encephalopathy Grade ≥2;
• functioning organ transplant or anticipated within 2 months; prior porto systemic shunt/TIPS;
• QTcF >480 ms or clinically significant ECG abnormalities;

Where it is running

• Research Site — Chandler, Arizona, United States (enrolling)
• Research Site — Rialto, California, United States (enrolling)
• Research Site — Miami Lakes, Florida, United States (enrolling)
• Research Site — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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