Actively Recruiting
Phase I Study Evaluating How Liver Impairment Affects Safety and Processing of AZD9550 and AZD6234 Given as Single Subcutaneous Doses
Led by AstraZeneca · Updated on 2026-08-04
28
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes pharmacokinetics two drugs, AZD9550 and AZD6234, in adults with different levels of liver impairment compared to those with normal liver function. This Phase I, open-label study includes participants with severe or moderate hepatic impairment as classified by the Child-Pugh score, as well as matched healthy controls. The goal is to understand how liver problems affect these drugs when given as single subcutaneous doses. Participants will receive separate single doses of AZD9550 and AZD6234 administered subcutaneously in two periods, with a washout period between the doses to reduce interference between drugs. The study groups include those with severe hepatic impairment Child-Pugh Class C, moderate hepatic impairment Child-Pugh Class B, and healthy individuals matched for sex, age, and body mass index. Approximately 16 participants with hepatic impairment and up to 12 healthy controls will be enrolled. During the study, participants will be assessed for drug levels in the body over 56 days after dosing to measure pharmacokinetic parameters such as AUCinf, AUClast, and Cmax. Safety and immune response will also be monitored through laboratory tests, vital signs, electrocardiograms, and adverse event reporting. The study duration includes screening, dosing periods, and follow-up visits to capture these outcomes under medical supervision.
CONDITIONS
Brief Title
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years at consent.
- For healthy controls: medically healthy with no significant clinical findings.
- For hepatic impairment groups: chronic, stable liver impairment for at least 6 months with Child-Pugh Class B or C.
- Stable medication regimen for at least 2 weeks before screening (hepatic impairment groups).
- Allowed type 2 diabetes with HbA1c less than 10% and no recent severe glycemic events.
- Body weight of at least 50 kg and body mass index between 18 and 42 kg/m².
- Male or female sex assigned at birth; females of childbearing potential must use effective contraception and have negative pregnancy tests.
- Written informed consent and optional consent for genomic testing.
You will not qualify if you...
- Healthy controls with any significant disease, diabetes, or abnormal lab values including elevated liver enzymes or low blood counts.
- Abnormal resting vital signs outside specified blood pressure or pulse ranges.
- ECG abnormalities including prolonged QT intervals.
- Severe allergies, recent major surgery, pancreatitis, high triglycerides, vitamin D deficiency, low calcium levels.
- Positive HIV, hepatitis B or C infections, or recent drug/alcohol abuse.
- For hepatic impairment groups: unstable medical or psychological conditions, poor kidney function, severe blood count abnormalities, recent gastrointestinal bleeding or procedures, fluctuating liver function, liver cancer.
- Use of prohibited medications including certain weight loss drugs, glucocorticoids, and contraceptives for non-contraceptive use.
- Prior exposure to study drugs or recent participation in other drug trials.
- Other factors such as inability to comply, vulnerable populations, or recent blood donations.
Research Team
A
AstraZeneca Clinical Study Information Center
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