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

31. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

104

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Arm A
Doses of AZD2389 to be administered orally.
Arzneimittel: 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.
Andere Namen:
  • Aktiver IMP
Placebo-Komparator: Arm B
Doses of placebo to be administered orally.
Sonstiges: Placebo
Orale Verabreichung

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to and including Day 197
Clinical Chemistry - ALP (U/L)
Up to and including Day 197

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Absolute change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 24 weeks
To assess the effects of AZD2389 versus placebo on improvement in LSM measured by Vibration-controlled transient elastography (VCTE)
24 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AstraZeneca

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

7. Mai 2026

Primärer Abschluss (Geschätzt)

7. Juli 2027

Studienabschluss (Geschätzt)

7. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

30. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Mai 2026

Zuerst gepostet (Tatsächlich)

28. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • D7930C00008

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

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.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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