RecruitingPhase 1

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

United States28 participantsStarted 2026-03-20

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18-85 years at consent.
. Groups:
. 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.

Exclusion criteria

. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PK parameters AUCinf

Timeframe: Day 0 through Day 56

PK parameters AUClast

Timeframe: Day 0 through Day 56

PK parameters Cmax

Timeframe: Day 0 through Day 56

Trial details

NCT IDNCT07546760

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-04

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

View on ClinicalTrials.gov More Hepatic Impairment trials

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18-85 years at consent.
. Groups:
. 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.

Exclusion criteria

. 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;