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A Phase I, Open-Label, Parallel-Group Study to Investigate the Effect of Liver Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD9550 and AZD6234
Led by AstraZeneca · Updated on 2026-06-03
28
Participants Needed
4
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the safety and how the body processes two drugs, AZD9550 and AZD6234, in people with different levels of liver problems compared to those with normal liver function. This Phase I, open-label study focuses on adults aged 18 to 85 who have severe or moderate hepatic impairment classified by Child-Pugh scores, as well as healthy controls matched for sex, age, and BMI. The study aims to understand how liver impairment affects these drugs' behavior in the body and their safety. Participants will receive a single subcutaneous dose of AZD9550 followed by a washout period, then a single dose of AZD6234. The study includes three groups: those with severe hepatic impairment (Child-Pugh Class C), moderate hepatic impairment (Class B), and healthy individuals with normal liver function. The study will monitor the drugs' pharmacokinetics separately to guide future dosing and safety considerations. During the trial, participants will be closely monitored from day 0 through day 56 for drug concentration levels and safety outcomes. Evaluations include blood tests for drug levels, immune response (antidrug antibodies), vital signs, and lab assessments. The study also tracks how the drugs are absorbed, distributed, metabolized, and eliminated. Participation involves several clinic visits for dosing and follow-up assessments, ensuring careful observation of the drugs' effects over nearly two months.
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
- Medically healthy for control group with no significant findings in medical history, examination, labs, vital signs, or ECG
- Chronic (6 months or more), stable hepatic impairment with Child-Pugh Class B or C for hepatic impairment groups
- Stable concomitant medication regimen for at least 2 weeks before screening for hepatic impairment groups
- Allowed type 2 diabetes with HbA1c below 10% and no severe hypo/hyperglycemia or hospitalization within 6 months
- Body weight at least 50 kg and BMI between 18 and 42 kg/m²
- Male or female sex assigned at birth with contraception as per local regulations
- Negative pregnancy tests and use of condoms plus one highly effective contraceptive method for females of childbearing potential through 54 days post last dose
- Condom use for males and no sperm donation through 54 days post last dose
- Written informed consent with optional separate consent for genomics
You will not qualify if you...
- For healthy controls: any clinically significant disease or diabetes
- Liver enzyme levels (ALT/AST/ALP) above 1.5 times the upper limit of normal
- Low white blood cell or platelet counts
- Low hemoglobin below 11.0 g/dL for females or 12.0 g/dL for males
- Abnormal vital signs outside specified blood pressure or pulse ranges
- QTcF interval over 450 ms or other significant ECG abnormalities
- Severe allergies or hypersensitivity
- Major surgery in past 30 days
- Pancreatitis or pancreatic enzyme levels above twice the upper limit
- High triglycerides over 500 mg/dL
- High calcitonin levels over 50 ng/L
- Severe vitamin D deficiency below 12 ng/mL
- Low corrected or ionized calcium levels
- Positive for HIV, hepatitis B or C antibodies, or recent drug/alcohol abuse within 1 year
- For hepatic impairment groups: unstable medical or psychological conditions
- Kidney function (eGFR) below 50 mL/min/1.73 m²
- Platelet counts below 35 x10⁹/L, neutrophils below 1.2 x10⁹/L, hemoglobin below 85 g/L
- Recent esophageal banding or gastrointestinal bleeding
- Ascites requiring frequent treatment or recent paracentesis
- Worsening liver function or liver cancer
- Acute liver disease from infection or drugs
- Biliary obstruction or non-liver causes of impairment
- Advanced hepatic encephalopathy
- Organ transplant or expected transplant soon
- QTcF interval over 480 ms or significant ECG abnormalities
- Recent use of study drugs or exposure to new chemical entities
- Use of prohibited medications affecting weight or QT interval
- Prior enrollment in this study or positive drug/alcohol screen
- Employees or close relatives of the study team
- Vulnerable populations or unlikely to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks including washout and observation
Participants receive a single subcutaneous dose of AZD9550 followed by a washout period, then a single subcutaneous dose of AZD6234 to assess pharmacokinetics, safety, and tolerability.
2 dosing visits plus multiple follow-up visits over 8 weeks
Duration - Up to 8 weeks post last dose
Participants are monitored for safety, immunogenicity, and pharmacokinetic parameters after dosing.
Multiple visits over 8 weeks
Trial Site Locations
Total: 4 locations
1
Research Site
Chandler, Arizona, United States, 85225
Actively Recruiting
2
Research Site
Rialto, California, United States, 92377
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3
Research Site
Miami Lakes, Florida, United States, 33014
Actively Recruiting
4
Research Site
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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