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 range18 Years – 85 Years

SexALL

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;
✕. 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);

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 range18 Years – 85 Years

SexALL

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;
✕. 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);