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

31 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

104

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Arm A
Doses of AZD2389 to be administered orally.
Medicamento: 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.
Outros nomes:
  • IMP ativo
Comparador de Placebo: Arm B
Doses of placebo to be administered orally.
Outro: Placebo
Administração oral

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Up to and including Day 197
Clinical Chemistry - ALP (U/L)
Up to and including Day 197

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Absolute change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 24 weeks
To assess the effects of AZD2389 versus placebo on improvement in LSM measured by Vibration-controlled transient elastography (VCTE)
24 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AstraZeneca

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

7 de maio de 2026

Conclusão Primária (Estimado)

7 de julho de 2027

Conclusão do estudo (Estimado)

7 de julho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

30 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de maio de 2026

Primeira postagem (Real)

28 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • D7930C00008

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de 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.

Critérios de acesso de compartilhamento 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 de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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