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

31 agosto 2026 aggiornato da: AstraZeneca

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)

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

104

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Arizona
      • Chandler, Arizona, Stati Uniti, 85224
        • Reclutamento
        • Research Site
      • Tucson, Arizona, Stati Uniti, 85712
        • Reclutamento
        • Research Site
    • Florida
      • Jupiter, Florida, Stati Uniti, 33458
        • Reclutamento
        • Research Site
      • Miami, Florida, Stati Uniti, 33122
        • Reclutamento
        • Research Site
      • Port Orange, Florida, Stati Uniti, 32127
        • Reclutamento
        • Research Site
    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64131
        • Reclutamento
        • Research Site
      • St Louis, Missouri, Stati Uniti, 63123
        • Reclutamento
        • Research Site
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89106
        • Reclutamento
        • Research Site
    • North Carolina
      • Morehead City, North Carolina, Stati Uniti, 28557
        • Reclutamento
        • Research Site
      • Raleigh, North Carolina, Stati Uniti, 27607
        • Reclutamento
        • Research Site
    • Ohio
      • Westlake, Ohio, Stati Uniti, 44145
        • Reclutamento
        • Research Site
    • Oklahoma
      • Yukon, Oklahoma, Stati Uniti, 73099
        • Reclutamento
        • Research Site
    • Tennessee
      • Clarksville, Tennessee, Stati Uniti, 37040
        • Reclutamento
        • Research Site
    • Texas
      • Austin, Texas, Stati Uniti, 78757
        • Reclutamento
        • Research Site
      • Denison, Texas, Stati Uniti, 75020
        • Reclutamento
        • Research Site
      • Georgetown, Texas, Stati Uniti, 78626
        • Reclutamento
        • Research Site
      • Houston, Texas, Stati Uniti, 77004
        • Reclutamento
        • Research Site
      • Houston, Texas, Stati Uniti, 77079
        • Reclutamento
        • Research Site
      • San Antonio, Texas, Stati Uniti, 78215
        • Reclutamento
        • Research Site
      • San Antonio, Texas, Stati Uniti, 78222
        • Reclutamento
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Key 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

Key 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm A
Doses of AZD2389 to be administered orally.
Droga: 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.
Altri nomi:
  • IMP attivo
Comparatore placebo: Arm B
Doses of placebo to be administered orally.
Altro: Placebo
Amministrazione orale

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24
Lasso di tempo: 24 weeks

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)
Lasso di tempo: Up to and including Day 197
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
Lasso di tempo: Up to and including Day 197
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)
Lasso di tempo: Up to and including Day 197
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
Lasso di tempo: Up to and including Day 197
Urinalysis - Paper chromatography
Up to and including Day 197
Number of participants with observed changes in heart rate (BPM) against baseline value
Lasso di tempo: Up to and including Day 197
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
Lasso di tempo: Up to and including Day 197
Sp02 oxygen saturations measured by percentage
Up to and including Day 197
Number of participants with observed changes in body temperature against baseline value
Lasso di tempo: Up to and including Day 197
Body temperature measured in degrees Celsius
Up to and including Day 197
Number of participants with observed changes in respiratory rate against baseline value
Lasso di tempo: Up to and including Day 197
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
Lasso di tempo: Up to and including Day 197
Hematology - Platelets (x10^9/L)
Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Lasso di tempo: Up to and including Day 197
Coagulation - INR
Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Lasso di tempo: Up to and including Day 197
Clinical Chemistry - ALT (U/L)
Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Lasso di tempo: Up to and including Day 197
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
Lasso di tempo: Up to and including Day 197
Clinical Chemistry - AST (U/L)
Up to and including Day 197
Number of participants with abnormal laboratory test results detected in blood samples
Lasso di tempo: Up to and including Day 197
Clinical Chemistry - ALP (U/L)
Up to and including Day 197

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Absolute change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24
Lasso di tempo: 24 weeks
To assess the effects of AZD2389 versus placebo on improvement in ProC3
24 weeks
Absolute change in Liver Stiffness Measurement (LSM) from baseline to week 24
Lasso di tempo: 24 weeks
To assess the effects of AZD2389 versus placebo on improvement in LSM measured by Vibration-controlled transient elastography (VCTE)
24 weeks
Absolute change in Controlled Attenuation Parameter (CAP) from baseline to week 24
Lasso di tempo: 24 weeks
To assess the effects of AZD2389 versus placebo on improvement in CAP
24 weeks
Percentage change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24
Lasso di tempo: 24 weeks
To assess the effects of AZD2389 versus placebo on improvement in ProC3
24 weeks
Percentage change in Liver Stiffness Measurement (LSM) from baseline to week 24
Lasso di tempo: 24 weeks
To assess the effects of AZD2389 versus placebo on improvement in LSM measured by Vibration-controlled transient elastography (VCTE)
24 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 maggio 2026

Completamento primario (Stimato)

7 luglio 2027

Completamento dello studio (Stimato)

7 luglio 2027

Date di iscrizione allo studio

Primo inviato

30 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2026

Primo Inserito (Effettivo)

28 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D7930C00008

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Periodo di condivisione IPD

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.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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