Hepatic ImpairmentPhase 1NCT07546760
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
A Phase 1 study testing AZD6234 and AZD9550 in people with Hepatic Impairment, run by AstraZeneca at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- AZD6234 and AZD9550
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Mar 2026to 4 Feb 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-85 years at consent.
- 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).
- 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.
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- 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.
Who cannot join
- Healthy controls only:
- 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;
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- major surgery within 30 days;
- pancreatitis or pancreatic enzymes >2×ULN;
- 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);
- low corrected or ionised calcium;
- HIV positive; HBV surface/core Ab or HCV Ab positive; drug/alcohol abuse within 1 year.
- Hepatically impaired only:
- Unstable medical/psychological conditions or uncontrolled systemic disease;
- eGFR <50 mL/min/1.73 m² (CKD EPI 2021);
- Abnormal resting vital signs i) SBP >160 or <100 mmHg, ii) DBP >110 or <65 mmHg, iii) pulse ≥100 or ≤50 bpm;
- platelets <35×10⁹/L; neutrophils <1.2×10⁹/L; haemoglobin <85 g/L; HbA1c ≥10%;
- oesophageal banding within 3 months or GI bleeding within 6 months;
- ascites requiring paracentesis and albumin ≤4 week intervals; paracentesis within 30 days;
- fluctuating/worsening hepatic function during screening; hepatocellular carcinoma;
- acute liver disease due to infection/drug; hepatic impairment due to non liver disease;
- biliary obstruction or non parenchymal causes; hepatic encephalopathy Grade ≥2;
- functioning organ transplant or anticipated within 2 months; prior porto systemic shunt/TIPS;
- QTcF >480 ms or clinically significant ECG abnormalities;
- pancreatitis or pancreatic enzymes >2×ULN;
- 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;
- 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;
- 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.
- 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:
- 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:
- 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:
- 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).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
United States4 sites, 3 recruiting
- Recruiting
Research Site
Chandler, Arizona, 85225
- Recruiting
Research Site
Miami Lakes, Florida, 33014
- Terminated
Research Site
Rialto, California, 92377
- Recruiting
Research Site
San Antonio, Texas, 78215
About this study
Official title: 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
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.
Read the detailed description
This Phase I, open-label, parallel group study will investigate the single SC dose PK, safety, tolerability, and immunogenicity of separate administrations of AZD9550 and AZD6234 to male and female participants with severe and moderate hepatic impairment compared to matched controls with normal hepatic function.
To minimize any potential impact from AZD9550 administered in Period 1, AZD6234 will be administered in Period 2 following a washout period. Results from separate injections will ultimately inform the single dose PK, safety, and tolerability of AZD9550 and AZD6234 administered.
Approximately 56 participants will be screened to achieve a total of 16 planned for study intervention (8 per group for CP Class C and CP Class B) with 6 evaluable participants in each of the 2 impairment groups (severe and moderate), and up to 12 participants with normal hepatic function. Initially 8 participants with normal hepatic function will be recruited, matched on a group level regarding sex, age, and BMI to the participants with hepatic impairment. Additional participants with normal hepatic function, up to a total of 12, may be included if needed to meet the matching criteria.
Child-Pugh scoring will be used to determine the level of hepatic impairment. Participants will be enrolled into the following groups based on their CP classification score as determined by a local laboratory at screening:
Group 1: Participants with severe hepatic impairment (CP Class C, score of 10 to 15).
Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).
Group 3: Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the participants with hepatic impairment
- Conditions
- Hepatic Impairment
- Being tested
- AZD6234, AZD9550
- Keywords
- Moderate, Severe, Matched Healthy Controls
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6234Drug
Single subcutaneous dose of AZD6234 in participants from all groups
AZD9550Drug
Single subcutaneous dose of AZD9550 in participants from all groups
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants with severe hepatic impairment (CP Class C, score of 10 to 15). Receives: Drug: AZD6234; Drug: AZD9550 |
| Group 2 | Experimental | Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). Receives: Drug: AZD6234; Drug: AZD9550 |
| Group 3 | Experimental | Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the participants with hepatic impairment. Receives: Drug: AZD6234; Drug: AZD9550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters AUCinf
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
Measured: Day 0 through Day 56
PK parameters AUClast
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
Measured: Day 0 through Day 56
PK parameters Cmax
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
Measured: Day 0 through Day 56
Secondary outcomes (5)
PK parameters tmax
To evaluate the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment and matched controls with normal hepatic function
Measured: Day 0 through Day 56
Prevalence and incidence of ADAs to AZD9550 and AZD6234
To evaluate the immunogenicity of AZD9550 and AZD6234 following separate single SC doses of AZD9550 and AZD6234
Measured: Day 0 through Day 56
PK parameters t1/2λz
To evaluate the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment and matched controls with normal hepatic function
Measured: Day 0 through Day 56
PK parameters CL/F
To evaluate the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment and matched controls with normal hepatic function
Measured: Day 0 through Day 56
PK parameters Vz/F
To evaluate the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment and matched controls with normal hepatic function
Measured: Day 0 through Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start20 Mar 2026
- Primary completion4 Feb 2027 (estimated)
- Study completion4 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be enrolled into the following groups based on their CP classification score as determined by a local laboratory at screening: Group 1: Participants with severe hepatic impairment (CP Class C, score of 10 to 15). Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). Group 3: Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the participants with hepatic impairment.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546760
- Sponsor's protocol ID
- D8460C00003
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.