The purpose of this study is to evaluate the safety, tolerability, and pharmacodynamic effects of AZD2389 in adult participants with steatotic liver disease (SLD) and advanced fibrosis.
Study details include: * The study duration will be approximately 32 weeks, including screening duration of 4 weeks, the treatment duration of up to 24 weeks, and follow-up period of 4 weeks. * The visit frequency will be approximately every 4 weeks except from Visit 2 to Visit 4, which is every 2 weeks. Disclosure Statement: This is a parallel group treatment study that is blinded to the participants and investigators. Number of Participants: Approximately 230 participants with SLD and advanced fibrosis will be screened such that approximately 104 participants will be randomised. Approximately 52 participants will be randomised to receive AZD2389 and approximately 52 participants will receive placebo. Note: 'Screened' means a participant's, or their legally authorised representative's, agreement to participate in a clinical study following completion of the informed consent process. Study Arms and Duration: Arm A will include 52 participants with SLD and advanced fibrosis who will receive oral AZD2389 for 24 weeks. Arm B will include 52 participants with SLD and advanced fibrosis who will receive oral placebo for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
Research Site
Chandler, Arizona, United States
RECRUITINGAbsolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24
To evaluate the effects of AZD2389 versus placebo on improvement in ELF score. Lowered ELF scores would suggest better outcome. Note: ELF is not bounded, i.e. there are no minimum and maximum values
Time frame: 24 weeks
Reported quantity and severity of adverse events (AEs)
To assess the safety and tolerability of AZD2389 in participants with SLD and advanced fibrosis
Time frame: Up to and including Day 197
Number of participants with observed changes in blood pressure against baseline mmHg value
Assess blood pressure level (with systolic and diastolic pressure) in mmHg
Time frame: Up to and including Day 197
Number of participants with identified abnormalities in results of 12-lead safety electrocardiograms (ECG)
12-lead safety ECG (PR interval, QRS complex, ST interval, T wave)
Time frame: Up to and including Day 197
Number of participants with abnormal laboratory results detected in urine samples
Urinalysis - Paper chromatography
Time frame: Up to and including Day 197
Number of participants with observed changes in heart rate (BPM) against baseline value
Pulse rate measured in beats per minute (BPM)
Time frame: Up to and including Day 197
Number of participants with observed changes in Sp02 oxygen values against baseline measurement
Sp02 oxygen saturations measured by percentage
Time frame: Up to and including Day 197
AstraZeneca Clinical Study Information Center
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Research Site
Tucson, Arizona, United States
RECRUITINGResearch Site
Jupiter, Florida, United States
RECRUITINGResearch Site
Miami, Florida, United States
RECRUITINGResearch Site
Port Orange, Florida, United States
RECRUITINGResearch Site
Kansas City, Missouri, United States
RECRUITINGResearch Site
St Louis, Missouri, United States
RECRUITINGResearch Site
Las Vegas, Nevada, United States
RECRUITINGResearch Site
Morehead City, North Carolina, United States
RECRUITINGResearch Site
Raleigh, North Carolina, United States
RECRUITING...and 10 more locations
Number of participants with observed changes in body temperature against baseline value
Body temperature measured in degrees Celsius
Time frame: Up to and including Day 197
Number of participants with observed changes in respiratory rate against baseline value
Respiratory rate measured in respirations per minute
Time frame: Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Hematology - Platelets (x10\^9/L)
Time frame: Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Coagulation - INR
Time frame: Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Clinical Chemistry - ALT (U/L)
Time frame: Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Fibrinolysis - D-dimer (ng/mL fibrinogen-equivalent units)
Time frame: Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Clinical Chemistry - AST (U/L)
Time frame: Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Clinical Chemistry - ALP (U/L)
Time frame: Up to and including Day 197
Absolute change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24
To assess the effects of AZD2389 versus placebo on improvement in ProC3
Time frame: 24 weeks
Absolute change in Liver Stiffness Measurement (LSM) from baseline to week 24
To assess the effects of AZD2389 versus placebo on improvement in LSM measured by Vibration-controlled transient elastography (VCTE)
Time frame: 24 weeks
Absolute change in Controlled Attenuation Parameter (CAP) from baseline to week 24
To assess the effects of AZD2389 versus placebo on improvement in CAP
Time frame: 24 weeks
Percentage change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24
To assess the effects of AZD2389 versus placebo on improvement in ProC3
Time frame: 24 weeks
Percentage change in Liver Stiffness Measurement (LSM) from baseline to week 24
To assess the effects of AZD2389 versus placebo on improvement in LSM measured by Vibration-controlled transient elastography (VCTE)
Time frame: 24 weeks