Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis (BRAVO)
2026年8月31日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
104
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：AstraZeneca Clinical Study Information Center
- 電話番号：1-877-240-9479
- メール：information.center@astrazeneca.com
研究場所
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Arizona
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Chandler、Arizona、アメリカ、85224
- 募集
- Research Site
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Tucson、Arizona、アメリカ、85712
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- Research Site
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Florida
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Jupiter、Florida、アメリカ、33458
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- Research Site
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Miami、Florida、アメリカ、33122
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- Research Site
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Port Orange、Florida、アメリカ、32127
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- Research Site
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Missouri
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Kansas City、Missouri、アメリカ、64131
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- Research Site
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St Louis、Missouri、アメリカ、63123
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- Research Site
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Nevada
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Las Vegas、Nevada、アメリカ、89106
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- Research Site
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North Carolina
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Morehead City、North Carolina、アメリカ、28557
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- Research Site
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Raleigh、North Carolina、アメリカ、27607
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- Research Site
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Ohio
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Westlake、Ohio、アメリカ、44145
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- Research Site
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Oklahoma
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Yukon、Oklahoma、アメリカ、73099
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- Research Site
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Tennessee
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Clarksville、Tennessee、アメリカ、37040
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- Research Site
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Texas
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Austin、Texas、アメリカ、78757
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- Research Site
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Denison、Texas、アメリカ、75020
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- Research Site
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Georgetown、Texas、アメリカ、78626
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- Research Site
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Houston、Texas、アメリカ、77004
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- Research Site
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Houston、Texas、アメリカ、77079
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- Research Site
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San Antonio、Texas、アメリカ、78215
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- Research Site
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San Antonio、Texas、アメリカ、78222
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- Research Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Arm A
Doses of AZD2389 to be administered orally.
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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.
他の名前：
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プラセボコンパレーター：Arm B
Doses of placebo to be administered orally.
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経口投与
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Absolute change in Enhanced Liver Fibrosis (ELF) score from baseline to week 24
時間枠：24 weeks
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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
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Reported quantity and severity of adverse events (AEs)
時間枠：Up to and including Day 197
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To assess the safety and tolerability of AZD2389 in participants with SLD and advanced fibrosis
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Up to and including Day 197
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Number of participants with observed changes in blood pressure against baseline mmHg value
時間枠：Up to and including Day 197
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Assess blood pressure level (with systolic and diastolic pressure) in mmHg
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Up to and including Day 197
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Number of participants with identified abnormalities in results of 12-lead safety electrocardiograms (ECG)
時間枠：Up to and including Day 197
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12-lead safety ECG (PR interval, QRS complex, ST interval, T wave)
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Up to and including Day 197
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Number of participants with abnormal laboratory results detected in urine samples
時間枠：Up to and including Day 197
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Urinalysis - Paper chromatography
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Up to and including Day 197
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Number of participants with observed changes in heart rate (BPM) against baseline value
時間枠：Up to and including Day 197
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Pulse rate measured in beats per minute (BPM)
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Up to and including Day 197
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Number of participants with observed changes in Sp02 oxygen values against baseline measurement
時間枠：Up to and including Day 197
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Sp02 oxygen saturations measured by percentage
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Up to and including Day 197
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Number of participants with observed changes in body temperature against baseline value
時間枠：Up to and including Day 197
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Body temperature measured in degrees Celsius
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Up to and including Day 197
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Number of participants with observed changes in respiratory rate against baseline value
時間枠：Up to and including Day 197
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Respiratory rate measured in respirations per minute
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Up to and including Day 197
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Number of participants with abnormal laboratory test results detected in blood samples
時間枠：Up to and including Day 197
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Hematology - Platelets (x10^9/L)
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Up to and including Day 197
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Number of participants with abnormal laboratory test results detected in blood samples
時間枠：Up to and including Day 197
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Coagulation - INR
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Up to and including Day 197
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Number of participants with abnormal laboratory test results detected in blood samples
時間枠：Up to and including Day 197
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Clinical Chemistry - ALT (U/L)
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Up to and including Day 197
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Number of participants with abnormal laboratory test results detected in blood samples
時間枠：Up to and including Day 197
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Fibrinolysis - D-dimer (ng/mL fibrinogen-equivalent units)
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Up to and including Day 197
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Number of participants with abnormal laboratory test results detected in blood samples
時間枠：Up to and including Day 197
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Clinical Chemistry - AST (U/L)
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Up to and including Day 197
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Number of participants with abnormal laboratory test results detected in blood samples
時間枠：Up to and including Day 197
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Clinical Chemistry - ALP (U/L)
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Up to and including Day 197
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Absolute change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24
時間枠：24 weeks
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To assess the effects of AZD2389 versus placebo on improvement in ProC3
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24 weeks
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Absolute change in Liver Stiffness Measurement (LSM) from baseline to week 24
時間枠：24 weeks
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To assess the effects of AZD2389 versus placebo on improvement in LSM measured by Vibration-controlled transient elastography (VCTE)
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24 weeks
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Absolute change in Controlled Attenuation Parameter (CAP) from baseline to week 24
時間枠：24 weeks
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To assess the effects of AZD2389 versus placebo on improvement in CAP
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24 weeks
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Percentage change in Procollagen Type III N-terminal Propeptide (ProC3) from baseline to week 24
時間枠：24 weeks
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To assess the effects of AZD2389 versus placebo on improvement in ProC3
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24 weeks
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Percentage change in Liver Stiffness Measurement (LSM) from baseline to week 24
時間枠：24 weeks
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To assess the effects of AZD2389 versus placebo on improvement in LSM measured by Vibration-controlled transient elastography (VCTE)
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24 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月7日
一次修了 (推定)
2027年7月7日
研究の完了 (推定)
2027年7月7日
試験登録日
最初に提出
2026年4月30日
QC基準を満たした最初の提出物
2026年5月20日
最初の投稿 (実際)
2026年5月28日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月1日
QC基準を満たした最後の更新が送信されました
2026年8月31日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
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