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Recruiting Phase 1

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

NCT07546760 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2026-03-20
Last updated
2026-10-22

Condition(s) studied

Hepatic Impairment

Investigational drug(s) / intervention(s)

AZD6234 →AZD9550 →

AZD6234: Single subcutaneous dose of AZD6234 in participants from all groups

AZD9550: Single subcutaneous dose of AZD9550 in participants from all groups

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
Accepted
Inclusion Criteria 1. Age 18-85 years at consent. 2. 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). 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).

Primary outcome measure(s)

  • PK parameters AUCinf — Day 0 through Day 56
    To compare the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment with matched controls with normal hepatic function
  • PK parameters AUClast — Day 0 through Day 56
    To compare the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment with matched controls with normal hepatic function
  • PK parameters Cmax — Day 0 through Day 56
    To compare the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment with matched controls with normal hepatic function

Trial sites (4)

FacilityCityRegionStatus
Research Site Chandler Arizona Recruiting
Research Site Rialto California Terminated
Research Site Miami Lakes Florida Recruiting
Research Site San Antonio Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07546760 on ClinicalTrials.gov ↗ ← All trials in the USA