Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH). MASH is more advanced stage of a broader liver disease, MASLD. MASLD is a liver condition caused by too much fat building up in the liver. This can lead to liver scarring and inflammation and can reduce the liver's ability to keep the body healthy. Cell death-inducing DFFA-like effector B (CIDEB) is a protein made by liver cells that helps the liver to store fat.
The study is looking at:
- What side effects ALN-CIDEB might cause
- How well ALN-CIDEB works to change liver fat, liver injury, and liver scarring
- How ALN-CIDEB could affect the body and the liver, which can help researchers understand why ALN-CIDEB works better for some people than others
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
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
研究場所
-
-
Texas
-
Georgetown、Texas、アメリカ、78628
- 募集
- Advanced Medical Trials
-
-
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 clinical diagnosis of MASLD, as defined in the protocol
- Has a liver stiffness measurement between 6 and 20 kilopascals (kPa), as measured by a FibroScan® scan during screening or within approximately 3 months of screening, as defined in the protocol
Key Exclusion Criteria:
- Has a known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol
- Has prior or current suspected or known drug-induced liver injury within approximately 1 year prior to screening
- Has a history of liver transplantation, current placement on a liver transplant list, or Model for End-Stage Liver Disease (MELD) score >12
- Has a known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion
- Has prior, current, or planned future use (during the treatment period) of a GLP-1 receptor agonist-based therapy or any medication approved for the treatment of MASH (eg, resmetirom) unless used at a generally stable dose and regimen since at least 3 months prior to screening visit and throughout the screening period with no change to the dose or regimen anticipated during the treatment period, as defined in the protocol
- Has evidence of uncontrolled human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection during screening, as defined in the protocol
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
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from Baseline in FibroScan Controlled Attenuation Parameter (CAP)
時間枠：At Week 52
|
At Week 52
|
|
Change from Baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE)
時間枠：At Week 52
|
At Week 52
|
|
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
|
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 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- ALN-CIDEB-MASLD-2604
- 2026-526723-22-00 (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。