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

2026년 8월 31일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

104

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Arm A
Doses of AZD2389 to be administered orally.
의약품: 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.
다른 이름들:
  • 활성 IMP
위약 비교기: Arm B
Doses of placebo to be administered orally.
다른: 위약
경구 투여

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Up to and including Day 197
Clinical Chemistry - ALP (U/L)
Up to and including Day 197

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 7일

기본 완료 (추정된)

2027년 7월 7일

연구 완료 (추정된)

2027년 7월 7일

연구 등록 날짜

최초 제출

2026년 4월 30일

QC 기준을 충족하는 최초 제출

2026년 5월 20일

처음 게시됨 (실제)

2026년 5월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 31일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D7930C00008

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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 공유 액세스 기준

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.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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