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New treatment option for Hepatic Impairment
Official title A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
ClinicalTrials.gov ID: NCT07546760
What this study is testing
What is AZD6234?
AZD6234 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hepatic impairment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- 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).
You likely can't join if
- Healthy controls only:
- Any clinically significant disease; Diabetes;
- lab values i) ALT/AST/ALP \>1.5×ULN; ii) WBC/platelets \ 1.2×ULN; iv) total bilirubin \>1.5×ULN (or Gilbert's);
- abnormal resting vital signs i) SBP \>150 or \ 95 or \<50 mmHg, iii) pulse ≥100 or ≤45 bpm;
- QTcF \>450 ms or clinically significant ECG abnormalities;
- severe allergy/hypersensitivity;
See the full eligibility criteria
- 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.
- 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...
- Written informed consent; separate consent for optional genomics.
- Healthy controls only:
- Any clinically significant disease; Diabetes;
- lab values i) ALT/AST/ALP \>1.5×ULN; ii) WBC/platelets \ 1.2×ULN; iv) total bilirubin \>1.5×ULN (or Gilbert's);
- abnormal resting vital signs i) SBP \>150 or \ 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);
- 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 \ 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Rialto, California, United States
- Miami Lakes, Florida, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Rialto, California, United States; Miami Lakes, Florida, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.