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Recruiting NCT07610837

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

Phase II Interventional Liver Fibrosis Hepatic Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AZD2389, Placebo.
Who it may be relevant to
Registry conditions: Liver Fibrosis, Hepatic Cirrhosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase IIa, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD2389 in Adult Participants With Steatotic Liver Disease and Advanced Fibrosis (BRAVO)

Overview

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.

Detailed description

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.

Interventions

  • Drug AZD2389
    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.
  • Other Placebo
    Oral administration

Primary outcome measures

  • Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24 [Time frame: 24 weeks]
  • Reported quantity and severity of adverse events (AEs) [Time frame: Up to and including Day 197]
  • Number of participants with observed changes in blood pressure against baseline mmHg value [Time frame: Up to and including Day 197]
  • Number of participants with identified abnormalities in results of 12-lead safety electrocardiograms (ECG) [Time frame: Up to and including Day 197]
  • Number of participants with abnormal laboratory results detected in urine samples [Time frame: Up to and including Day 197]
  • Number of participants with observed changes in heart rate (BPM) against baseline value [Time frame: Up to and including Day 197]
  • Number of participants with observed changes in Sp02 oxygen values against baseline measurement [Time frame: Up to and including Day 197]
  • Number of participants with observed changes in body temperature against baseline value [Time frame: Up to and including Day 197]
  • Number of participants with observed changes in respiratory rate against baseline value [Time frame: Up to and including Day 197]
  • Number of participants with abnormal laboratory test results detected in blood samples [Time frame: Up to and including Day 197]
Secondary outcome measures (5)
  • Absolute change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24 [Time frame: 24 weeks]
  • Absolute change in Liver Stiffness Measurement (LSM) from baseline to week 24 [Time frame: 24 weeks]
  • Absolute change in Controlled Attenuation Parameter (CAP) from baseline to week 24 [Time frame: 24 weeks]
  • Percentage change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24 [Time frame: 24 weeks]
  • Percentage change in Liver Stiffness Measurement (LSM) from baseline to week 24 [Time frame: 24 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Other protocol-defined exclusions, including significant abnormal labs (e.g., worsening ALT/AST), recent participation in another IMP study, or investigator judgment of unsuitability.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 20 centers
  • Research Site — Chandler
  • Research Site — Tucson
  • Research Site — Jupiter
  • Research Site — Miami
  • Research Site — Port Orange
  • Research Site — Kansas City
  • Research Site — St Louis
  • Research Site — Las Vegas
  • … and 12 more centers

Identifiers

NCT: NCT07610837 · D7930C00008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗