Study of AZD9550 and AZD6234 in People with Liver Impairment

This study is looking at how two drugs, AZD9550 and AZD6234, are processed in the body and how safe they are for people with different levels of liver impairment (hepatic impairment). It also includes healthy volunteers. Researchers want to understand if liver problems change how these drugs work. You may be able to join if you are 18 to 85 years old and have stable, chronic liver impairment (Child-Pugh B or C) or are a healthy adult. The study will measure how much of the drugs are in your body over time (PK parameters AUCinf, AUClast, and Cmax) for up to 56 days after you receive the medication. The current status of this study is unclear, and it plans to enroll 28 participants.

Study design
This is a Phase I, open-label study, meaning you and the study team will know which drug you are receiving. It will compare participants with liver impairment to healthy volunteers, with a total of 28 planned participants.
What's involved
You will receive a single dose of AZD9550 and a single dose of AZD6234, separated by a washout period. The study will track drug levels in your body for up to 56 days.
Compensation
Not stated in the trial record.
Follow-up
Your drug levels will be measured for up to 56 days after receiving the medication.

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NCT07546760

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

Recruiting
PHASE1Ages 18–85Interventional
AstraZeneca
~28 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:AZD6234AZD9550

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PK parameters AUCinf
Measured over Day 0 through Day 56
+2 more outcomes measured
Hepatic Impairment
4 sites across 4 states
Arizona1
California1
Florida1
Texas1
AstraZeneca Clinical Study Information Center
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Eligibility criteria

Inclusion

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.
  • PK parameters AUCinfDay 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 AUClastDay 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 CmaxDay 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