Actively Recruiting
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
Led by AstraZeneca · Updated on 2026-05-05
28
Participants Needed
4
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 18 to 85 years at consent
- Medically healthy for healthy controls with no significant findings in history, exam, labs, vitals, or ECG
- Chronic, stable hepatic impairment for at least 6 months with Child-Pugh Class B or C
- Stable medication regimen for at least 2 weeks before screening for hepatic impairment groups
- Type 2 diabetes allowed if HbA1c less than 10% and no severe hypo/hyperglycemia or hospitalizations in past 6 months
- Body weight at least 50 kg and BMI between 18 and 42 kg/m2
- Male or female assigned at birth; females of childbearing potential must have negative pregnancy tests and use condoms plus one other effective contraception through 54 days after last dose; males must use condoms and avoid sperm donation through 54 days after last dose
- Written informed consent provided; separate consent for optional genomics
You will not qualify if you...
- Healthy controls with any clinically significant disease or diabetes
- Healthy controls with abnormal lab values including elevated liver enzymes, low blood counts, abnormal clotting times, or high bilirubin
- Abnormal resting vital signs outside specified blood pressure or pulse ranges for healthy controls
- QTcF over 450 ms or significant ECG abnormalities
- Severe allergies or hypersensitivity
- Major surgery within 30 days
- Pancreatitis or elevated pancreatic enzymes
- High triglycerides over 500 mg/dL
- Calcitonin above 50 ng/L
- Severe vitamin D deficiency
- Low corrected or ionized calcium
- HIV positive or positive for hepatitis B or C antibodies; recent drug or alcohol abuse within 1 year
- Hepatically impaired participants with unstable medical or psychological conditions or uncontrolled systemic disease
- Reduced kidney function with eGFR below 50 mL/min/1.73 m2
- Abnormal resting vital signs outside specified ranges for hepatic impairment group
- Low blood counts below specified thresholds or HbA1c 10% or higher
- Recent esophageal banding or gastrointestinal bleeding
- Ascites requiring frequent paracentesis or recent paracentesis
- Fluctuating or worsening liver function during screening or liver cancer
- Acute liver disease due to infection or drugs; liver impairment not caused by liver disease
- Biliary obstruction or non-parenchymal causes; hepatic encephalopathy Grade 2 or higher
- Functioning or expected organ transplant; prior porto systemic shunt or TIPS
- QTcF over 480 ms or significant ECG abnormalities
- Pancreatitis or elevated pancreatic enzymes
- High triglycerides or calcitonin; severe vitamin D deficiency; low ionized calcium
- Recent or active neoplastic disease except certain treated cancers; medullary thyroid carcinoma or MEN2
- HIV positive or positive hepatitis B/C antibodies unless viral DNA/RNA negative on follow-up; recent drug or alcohol abuse
- Recent exposure to new chemical entities or prior exposure to study drugs
- Use of certain medications including weight loss drugs, glucocorticoids, QT prolonging agents, oral contraceptives except as allowed
- Prior enrollment in this study; positive drug or alcohol screens; recent blood donations; employees or relatives; vulnerable populations; unlikely to comply as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Research Site
Chandler, Arizona, United States, 85225
Actively Recruiting
2
Research Site
Rialto, California, United States, 92377
Actively Recruiting
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here