Study to Evaluate ALN-CIDEB in Adults With Fibrotic Alcohol-Associated Liver Disease (ALD)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALN-CIDEB in Adults With Alcohol-Associated Liver Disease (ALD) With Moderate to Advanced Fibrosis
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called alcohol-associated liver disease (ALD). ALD is a type of liver disease caused by drinking alcohol at levels that are harmful to the body. The study will also test ALN-CIDEB in participants who are known to have metabolic dysfunction- and alcohol- associated liver disease (MetALD), a subgroup of people that have features of both ALD and metabolic dysfunction-associated steatotic liver disease (MASLD).
The study will compare 2 different dose regimens of ALN-CIDEB with placebo (something that looks like the study drug but doesn't contain any medicine) to understand how well ALN-CIDEB works to lower the amount of fat in the liver.
The study is looking at:
- What side effects ALN-CIDEB might cause
- How well ALN-CIDEB works to change liver fat and stiffness of the liver
- How ALN-CIDEB could affect the liver proteins
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Clinical Trials Administrator
- 電話番号：844-734-6643
- メール：clinicaltrials@regeneron.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Key Inclusion Criteria:
- Has a diagnosis of alcohol-associated liver disease (with or without MetALD), as determined by the investigator
- Has a liver stiffness measurement ≥7 and <20 kilopascal (kPa) by FibroScan at Screening Visit 1
- Has a controlled attenuation parameter ≥285 decibels per meter (dB/m) by FibroScan at Screening Visit 1
- Has liver fat content ≥8.5% by MRI-PDFF at Screening Visit 2
Key Exclusion Criteria:
- Has known chronic liver disease other than MetALD or ALD, as determined by the investigator and as defined in the protocol
- Has history of or current alcohol-associated hepatitis (AH) at screening, as determined by the investigator
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
研究計画
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：プラセボ
|
Administered per the protocol |
|
実験的：ALN-CIDEB Dose Level 1
|
Administered per the protocol |
|
実験的：ALN-CIDEB Dose Level 2
|
Administered per the protocol |
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 |
時間枠 |
|---|---|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
時間枠：Through Week 64
|
Through Week 64
|
|
Severity of TEAEs
時間枠：Through Week 64
|
Through Week 64
|
|
Percent Change from Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat fraction (MRI-PDFF)
時間枠：At Week 52
|
At Week 52
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from Baseline in Aspartate Aminotransferase (AST)
時間枠：Through Week 64
|
Through Week 64
|
|
Change from Baseline in Alanine Aminotransferase (ALT)
時間枠：Through Week 64
|
Through Week 64
|
|
Change from Baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE)
時間枠：Through Week 52
|
Through Week 52
|
|
Change from Baseline in Enhanced Liver Fibrosis (ELF)
時間枠：Through Week 52
|
Through Week 52
|
|
Change from Baseline in FibroScan Controlled Attenuation Parameter (CAP)
時間枠：Through Week 52
|
Through Week 52
|
協力者と研究者
捜査官
- スタディディレクター：Clinical Trial Management、Regeneron Pharmaceuticals
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
- 慢性肝疾患
- 脂肪肝
- 肝硬変
- siRNA
- 肝線維症
- アルコール性肝炎
- 進行した線維症
- 門脈圧亢進症
- アルコール使用障害 (AUD)
- 肝線維症
- アルコール性肝疾患
- 脂肪肝疾患
- 低分子干渉リボ核酸
- 代謝機能障害関連脂肪性肝炎 (MASH)
- 末期肝疾患
- Alcohol-Related Liver Disease
- Alcoholic Cirrhosis
- Alcohol-Induced Liver Disease
- Alcohol-Associated Hepatitis (AH)
- Alcohol-Associated Steatohepatitis (ASH)
- Alcoholic Steatohepatitis
- Alcohol-Associated Steatosis
- Alcoholic Fatty Liver
- Alcohol-Associated Cirrhosis
- Moderate Fibrosis
- Acute-on-Chronic Liver Failure (ACLF)
- Liver Disease from Alcohol
- Alcohol-Related Liver Damage
- Metabolic dysfunction- and alcohol- associated liver disease (MetALD)
追加の関連 MeSH 用語
その他の研究ID番号
- ALN-CIDEB-ALD-25113
- 2026-527097-37-00 (Ctis)
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?
IPD プランの説明
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD 共有時間枠
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD 共有アクセス基準
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。