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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
Lead sponsor
Assets
AZD6234 / AZD9550
Listed sites
4
Recruiting sites
4
Enrollment
28
estimated
Study population
Healthy volunteers, Hepatic impairment
Key I/E criteria
•BMI 18-42•HbA1c ≤10%•Healthy volunteers
Primary endpoints
•PK parameters AUCinf•PK parameters AUClast•PK parameters Cmax
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Age 18-85 years at consent.
2. Groups:
3. Stable concomitant regimen ≥2 weeks before screening (Groups 1-2).
4. T2DM allowed if HbA1c <10% and no severe hypo/hyperglycaemia or hospitalisation within 6 months.
5. Body weight ≥50 kg; BMI 18-42 kg/m².
6. 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.
7. Written informed consent; separate consent for optional genomics.
Exclusion criteria
Healthy controls only:
1. Any clinically significant disease; Diabetes;
2. 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);
3. abnormal resting vital signs i) SBP >150 or <90 mmHg, ii) DBP >95 or <50 mmHg, iii) pulse ≥100 or ≤45 bpm;
4. QTcF >450 ms or clinically significant ECG abnormalities;
5. severe allergy/hypersensitivity;
6. major surgery within 30 days;
7. pancreatitis or pancreatic enzymes >2×ULN;
8. triglycerides >500 mg/dL (5.6 mmol/L);
9. calcitonin >50 ng/L (50 pg/mL);
10. severe vitamin D deficiency (<12 ng/mL, 30 nmol/L);
11. low corrected or ionised calcium;
12. HIV positive; HBV surface/core Ab or HCV Ab positive; drug/alcohol abuse within 1 year.
Hepatically impaired only:
13. Unstable medical/psychological conditions or uncontrolled systemic disease;
14. eGFR <50 mL/min/1.73 m² (CKD EPI 2021);
15. Abnormal resting vital signs i) SBP >160 or <100 mmHg, ii) DBP >110 or <65 mmHg, iii) pulse ≥100 or ≤50 bpm;
16. platelets <35×10⁹/L; neutrophils <1.2×10⁹/L; haemoglobin <85 g/L; HbA1c ≥10%;
17. oesophageal banding within 3 months or GI bleeding within 6 months;
18. ascites requiring paracentesis and albumin ≤4 week intervals; paracentesis within 30 days;
19. fluctuating/worsening hepatic function during screening; hepatocellular carcinoma;
20. acute liver disease due to infection/drug; hepatic impairment due to non liver disease;
21. biliary obstruction or non parenchymal causes; hepatic encephalopathy Grade ≥2;
22. functioning organ transplant or anticipated within 2 months; prior porto systemic shunt/TIPS;
23. QTcF >480 ms or clinically significant ECG abnormalities;
24. pancreatitis or pancreatic enzymes >2×ULN;
25. 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); ionised calcium <LLN;
26. neoplastic disease within 10 years (except adequately treated BCC/SCC or in situ cervical); MEN2 or medullary thyroid carcinoma (personal or first degree relative); significant gastric emptying abnormality;
27. HIV positive; HBV surface/core Ab or HCV Ab positive (may be included if HBV DNA or HCV RNA negative on follow up); drug/alcohol abuse within 1 year.
28. Exposure to a new chemical entity within 30 days or 5 half lives (whichever longer) before intervention; prior exposure to AZD9550 or AZD6234;
Prior/concomitant therapy:
Healthy controls:
29. use of prescription/non prescription/supplements 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.
Hepatically impaired:
30. prohibited-weight loss medicines (including GLP 1), agents causing significant weight gain (e.g., systemic glucocorticoids, antipsychotics), GLP 1 RAs for diabetes, QT prolonging/prokinetic 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/SU/GLP 1 RA, discontinue from study.
Other:
31. prior enrolment in this study (screened without dosing permitted). Positive drugs of abuse and/or alcohol screen (except prescribed meds in hepatic impairment); recent blood products/donation per protocol thresholds; employees or close relatives; vulnerable populations; unlikely to comply (investigator judgement).
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
8 endpointsPK parameters AUCinf
Time frame:Day 0 through Day 56
descriptive
PK parameters AUClast
Time frame:Day 0 through Day 56
descriptive
PK parameters Cmax
Time frame:Day 0 through Day 56
concentration, descriptive
PK parameters tmax
Time frame:Day 0 through Day 56
concentration, descriptive
PK parameters t1/2λz
Time frame:Day 0 through Day 56
concentration, descriptive
PK parameters CL/F
Time frame:Day 0 through Day 56
descriptive
PK parameters Vz/F
Time frame:Day 0 through Day 56
descriptive
Incidence of AEs, SAEs
Time frame:Screening through Day 56
event count, event
Other clinical outcomes
1 endpointPrevalence and incidence of ADAs to AZD9550 and AZD6234
Time frame:Day 0 through Day 56
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.