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Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis

ConditionsLiver FibrosisHepatic Cirrhosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males/females aged 18 or over

A diagnosis of SLD with advanced fibrosis

No significant change in weight over the last 6 months

Contraceptive us by participants or participants partners

Disqualifiers

Portal hypertension (LSM >25 kPa or 20-25 kPa with platelets <150×10⁹/L), decompensated liver disease, Child-Pugh >A6, MELD >12, other chronic liver diseases, prior/planned liver transplant, or malignant liver tumors.

Positive viral infections, including HIV or hepatitis B, or hepatitis C unless HCV RNA-negative ≥12 weeks after treatment.

Alcohol intake above protocol thresholds, or positive screen for drugs of abuse.

Significant metabolic, cardiovascular, or GI disorders, including T1DM or insulin-treated T2DM, uncontrolled hypertension, recent major cardiac/cerebrovascular events, severe heart failure, serious arrhythmias, significant pancreatic disease, or major GI surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AZD2389

    Drug

    potent, selective, first-in-class, small molecule oral inhibitor of FAP and is being developed for the treatment of CLDs with advanced hepatic fibrosis including cirrhosis.

  • Placebo

    Other intervention

    Oral administration

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Absolute 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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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