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Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

1 juni 2026 uppdaterad av: Regeneron Pharmaceuticals

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH.

In this study, researchers are looking at the effect of ALN-CIDEB on reducing liver fat, liver injury, and liver scarring. The study will compare ALN-CIDEB with placebo 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, liver injury, and liver scarring
  • How the body and the liver change after having ALN-CIDEB, which can help researchers understand why ALN-CIDEB works better for some people than others

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

150

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Key Inclusion Criteria:

  1. A diagnosis of MASH documented in the participant's medical history, or a clinical suspicion of MASH based on non-invasive biomarkers and clinical risk factors, including having a history of 1 or more elements of metabolic syndrome as described in the protocol
  2. Screening percutaneous liver biopsy demonstrating a NAFLD Activity Score (NAS) ≥4 and fibrosis stage F2 or F3 as described in the protocol
  3. Has a FibroScan Aspartate aminotransferase (FAST) score >0.35 either at Screening Visit 1 or within approximately 3 months of Screening Visit 1 as described in the protocol

Key Exclusion Criteria:

  1. Known chronic liver disease other than Metabolic dysfunction-Associated steatotic Liver Disease (MASLD), as determined by the investigator as described in the protocol
  2. Prior or current suspected or known drug-induced liver injury within approximately 1 year prior to Screening Visit 1
  3. History of liver transplantation, current placement on a liver transplant list, or MELD score >12
  4. Known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion and/or a score on the AUDIT questionnaire ≥8
  5. Prior current, or planned future use of a Glucagon-Like Peptide-1 (GLP-1) receptor agonist-based therapy or any medication approved for the treatment of MASH unless used at a generally stable dose and regimen since at least 3 months prior to Screening Visit 1 or the qualifying historical liver biopsy and throughout the screening period with no change to the dose or regimen anticipated during the treatment period as described in the protocol

NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
Läkemedel: Placebo
Administreras enligt protokollet
Experimentell: ALN-CIDEB Dose 1
Läkemedel: Aln-cideb
Administreras per protokollet
Experimentell: ALN-CIDEB Dose 2
Läkemedel: Aln-cideb
Administreras per protokollet

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Percent change from baseline in liver fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF)
Tidsram: At week 26
At week 26

Sekundära resultatmått

Resultatmått
Tidsram
Resolution of MASH with no worsening of Nonalcoholic Steatohepatitis-Clinical Research Network (NASH-CRN) fibrosis on liver biopsy
Tidsram: At week 52
At week 52
Percent change from baseline in liver fat by MRI-PDFF
Tidsram: At week 52
At week 52
Achievement of a ≥30% reduction in liver fat by MRI-PDFF
Tidsram: At week 52
At week 52
Achievement of ≤5% liver fat by MRI-PDFF
Tidsram: At week 52
At week 52
Percent change from baseline in liver fat by MRI-PDFF for each dose level of ALN-CIDEB
Tidsram: Up to week 52
Up to week 52
Improvement of NASH-CRN Fibrosis Stage (F) by ≥1 with no worsening of MASH
Tidsram: At week 52
At week 52
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Tidsram: Up to week 64
Up to week 64
Severity of TEAEs
Tidsram: Up to week 64
Up to week 64
Change from baseline in FibroScan Controlled Attenuation Parameter (CAP)
Tidsram: Through week 52
Through week 52
Change from baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE)
Tidsram: Through week 52
Through week 52
Change from baseline in Aspartate Aminotransferase (AST)
Tidsram: Up to week 64
Up to week 64
Change from baseline in Alanine Aminotransferase (ALT)
Tidsram: Up to week 64
Up to week 64
Change from baseline in Enhanced Liver Fibrosis (ELF)
Tidsram: Through week 52
Through week 52
Change from baseline in PRO-C3
Tidsram: Through week 52
Through week 52
Change from baseline in ADAPT
Tidsram: Through week 52
Through week 52
Change from baseline in NIS2+
Tidsram: Through week 52
Through week 52
Percent change from baseline in liver fat by MRI-PDFF in genetic subpopulations
Tidsram: At week 52
At week 52

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Regeneron Pharmaceuticals

Utredare

  • Studierektor: Clinical Trial Management, Regeneron Pharmaceuticals

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 juli 2026

Primärt slutförande (Beräknad)

6 februari 2029

Avslutad studie (Beräknad)

6 februari 2029

Studieregistreringsdatum

Först inskickad

1 juni 2026

Först inskickad som uppfyllde QC-kriterierna

1 juni 2026

Första postat (Faktisk)

8 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juni 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ALN-CIDEB-MASH-2603
  • 2026-525916-33-00 (Ctis)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • ANALYTIC_CODE
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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