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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 actualizado 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

104

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Otros nombres:
  • IMP activo
Comparador de placebos: Arm B
Doses of placebo to be administered orally.
Otro: Placebo
Administracion oral

¿Qué mide el estudio?

Medidas de resultado primarias

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Absolute change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AstraZeneca

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

7 de mayo de 2026

Finalización primaria (Estimado)

7 de julio de 2027

Finalización del estudio (Estimado)

7 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

30 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

20 de mayo de 2026

Publicado por primera vez (Actual)

28 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • D7930C00008

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir 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.

Criterios de acceso compartido de 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 información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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