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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Clinical Trials Administrator
- Telefonnummer: 844-734-6643
- E-post: clinicaltrials@regeneron.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
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
|
Administered per the protocol |
|
Eksperimentell: ALN-CIDEB Dose Level 1
|
Administered per the protocol |
|
Eksperimentell: ALN-CIDEB Dose Level 2
|
Administered per the protocol |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Through Week 64
|
Through Week 64
|
|
Severity of TEAEs
Tidsramme: Through Week 64
|
Through Week 64
|
|
Percent Change from Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat fraction (MRI-PDFF)
Tidsramme: At Week 52
|
At Week 52
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change from Baseline in Aspartate Aminotransferase (AST)
Tidsramme: Through Week 64
|
Through Week 64
|
|
Change from Baseline in Alanine Aminotransferase (ALT)
Tidsramme: Through Week 64
|
Through Week 64
|
|
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 Enhanced Liver Fibrosis (ELF)
Tidsramme: Through Week 52
|
Through Week 52
|
|
Change from Baseline in FibroScan Controlled Attenuation Parameter (CAP)
Tidsramme: Through Week 52
|
Through Week 52
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- Kronisk leversykdom
- Hepatisk Steatose
- Skrumplever
- siRNA
- Leverfibrose
- Alkoholisk hepatitt
- Avansert fibrose
- Portal hypertensjon
- Alkoholbruksforstyrrelse (AUD)
- Hepatisk fibrose
- Alkoholisk leversykdom
- Fettleversykdom
- Liten forstyrrende ribonukleinsyre
- Metabol dysfunksjon-assosiert steatohepatitt (MASH)
- Endestadium leversykdom
- 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)
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske prosesser
- Sykdommer i fordøyelsessystemet
- Leversykdommer
- Stoffrelaterte lidelser
- Kjemisk-induserte lidelser
- Alkoholrelaterte lidelser
- Leversvikt
- Leverinsuffisiens
- Hepatitt
- Leversvikt, akutt
- Alkohol-induserte lidelser
- Patologiske tilstander, tegn og symptomer
- Alkoholisme
- Fibrose
- Fettlever
- Ikke-alkoholisk fettleversykdom
- Levercirrhose
- Hypertensjon, Portal
- Sluttstadium leversykdom
- Akutt-på-kronisk leversvikt
- Hepatitt, alkoholiker
- Levercirrhose, alkoholholdig
- Leversykdommer, alkoholholdig
- Fettlever, alkoholholdig
Andre studie-ID-numre
- ALN-CIDEB-ALD-25113
- 2026-527097-37-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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
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