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

NCT07610837 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: D7930C00008
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Liver Fibrosis; Hepatic Cirrhosis

Keywords

Liver Fibrosis; Hepatic Cirrhosis

Outcome Measures

Primary Outcomes (15)

• 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

  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

  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

  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)

  Up to and including Day 197

• Number of participants with abnormal laboratory results detected in urine samples

  Urinalysis - Paper chromatography

  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)

  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

  Up to and including Day 197

• Number of participants with observed changes in body temperature against baseline value

  Body temperature measured in degrees Celsius

  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

  Up to and including Day 197

• Number of participants with abnormal laboratory test results detected in blood samples

  Hematology - Platelets (x10\^9/L)

  Up to and including Day 197

• Number of participants with abnormal laboratory test results detected in blood samples

  Coagulation - INR

  Up to and including Day 197

• Number of participants with abnormal laboratory test results detected in blood samples

  Clinical Chemistry - ALT (U/L)

  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)

  Up to and including Day 197

• Number of participants with abnormal laboratory test results detected in blood samples

  Clinical Chemistry - AST (U/L)

  Up to and including Day 197

• Number of participants with abnormal laboratory test results detected in blood samples

  Clinical Chemistry - ALP (U/L)

  Up to and including Day 197

Secondary Outcomes (5)

• Absolute change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24

  24 weeks

• Absolute change in Liver Stiffness Measurement (LSM) from baseline to week 24

  24 weeks

• Absolute change in Controlled Attenuation Parameter (CAP) from baseline to week 24

  24 weeks

• Percentage change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24

  24 weeks

• Percentage change in Liver Stiffness Measurement (LSM) from baseline to week 24

  24 weeks

Study Arms (2)

Arm A

EXPERIMENTAL

Doses of AZD2389 to be administered orally.

Drug: AZD2389

Arm B

PLACEBO COMPARATOR

Doses of placebo to be administered orally.

Other: Placebo

Interventions

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.

Also known as: Active IMP

Arm A

Placebo OTHER

Oral administration

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Capable of giving informed consent
• Judged by the investigator to be suitable for study

You may not qualify if:

• 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.
• History of psychosis, bipolar disorder, recent major depression, or suicide attempt/ideation within 1 year.
• Bleeding risk or wound-healing concerns, including coagulation disorders, major bleeding history, active wounds or recent major surgery, or severe dermatologic immune conditions.
• Prohibited medications or hypersensitivities, including moderate/strong CYP3A4 or BCRP/OAT3 inhibitors/inducers, anticoagulants/antiplatelets (except aspirin ≤81 mg/day), or hypersensitivity to DPP4 inhibitors.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (19)

Research Site

Chandler, Arizona, 85224, United States

NOT YET RECRUITING

Research Site

Jupiter, Florida, 33458, United States

NOT YET RECRUITING

Research Site

Miami, Florida, 33122, United States

NOT YET RECRUITING

Research Site

Port Orange, Florida, 32127, United States

NOT YET RECRUITING

Research Site

Kansas City, Missouri, 64131, United States

NOT YET RECRUITING

Research Site

St Louis, Missouri, 63123, United States

NOT YET RECRUITING

Research Site

Las Vegas, Nevada, 89106, United States

NOT YET RECRUITING

Research Site

Morehead City, North Carolina, 28557, United States

RECRUITING

Research Site

Raleigh, North Carolina, 27607, United States

NOT YET RECRUITING

Research Site

Westlake, Ohio, 44145, United States

NOT YET RECRUITING

Research Site

Yukon, Oklahoma, 73099, United States

NOT YET RECRUITING

Research Site

Clarksville, Tennessee, 37040, United States

NOT YET RECRUITING

Research Site

Austin, Texas, 78757, United States

NOT YET RECRUITING

Research Site

Denison, Texas, 75020, United States

NOT YET RECRUITING

Research Site

Georgetown, Texas, 78626, United States

NOT YET RECRUITING

Research Site

Houston, Texas, 77004, United States

NOT YET RECRUITING

Research Site

Houston, Texas, 77079, United States

NOT YET RECRUITING

Research Site

San Antonio, Texas, 78215, United States

RECRUITING

Research Site

San Antonio, Texas, 78222, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a parallel group treatment study that is blinded to the participants and investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase IIa, randomised, double-blind, placebo-controlled, multicentre study to assess the safety, tolerability and PD effects of AZD2389 in participants with SLD and advanced fibrosis. Randomisation will be stratified by, type 2 diabetes mellitus (T2DM), and alcohol use. The purpose of this study is to evaluate the safety, tolerability, and PD of AZD2389 in adult participants with 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.

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 28, 2026
• Study Start: May 7, 2026
• Primary Completion (Estimated): July 7, 2027
• Study Completion (Estimated): July 7, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (19)