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

1. juni 2026 oppdatert 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Legemiddel: Placebo
Administrert i henhold til protokollen
Eksperimentell: ALN-CIDEB Dose 1
Legemiddel: Aln-Cideb
Administrert i henhold til protokollen
Eksperimentell: ALN-CIDEB Dose 2
Legemiddel: Aln-Cideb
Administrert i henhold til protokollen

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Regeneron Pharmaceuticals

Etterforskere

  • Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juli 2026

Primær fullføring (Antatt)

6. februar 2029

Studiet fullført (Antatt)

6. februar 2029

Datoer for studieregistrering

Først innsendt

1. juni 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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