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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Clinical Trials Administrator
- Telefonnummer: 844-734-6643
- E-post: clinicaltrials@regeneron.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
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
|
Administered per the protocol |
|
Experimentell: ALN-CIDEB Dose Level 1
|
Administered per the protocol |
|
Experimentell: ALN-CIDEB Dose Level 2
|
Administered per the protocol |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Tidsram: Through Week 64
|
Through Week 64
|
|
Severity of TEAEs
Tidsram: Through Week 64
|
Through Week 64
|
|
Percent Change from Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat fraction (MRI-PDFF)
Tidsram: At Week 52
|
At Week 52
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change from Baseline in Aspartate Aminotransferase (AST)
Tidsram: Through Week 64
|
Through Week 64
|
|
Change from Baseline in Alanine Aminotransferase (ALT)
Tidsram: Through Week 64
|
Through Week 64
|
|
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 Enhanced Liver Fibrosis (ELF)
Tidsram: Through Week 52
|
Through Week 52
|
|
Change from Baseline in FibroScan Controlled Attenuation Parameter (CAP)
Tidsram: Through Week 52
|
Through Week 52
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Clinical Trial Management, Regeneron Pharmaceuticals
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- Kronisk leversjukdom
- Hepatisk Steatos
- Cirros
- siRNA
- Leverfibros
- Alkoholisk hepatit
- Avancerad fibros
- Portal hypertoni
- Alkoholmissbruk (AUD)
- Leverfibros
- Alkoholisk leversjukdom
- Fettleversjukdom
- Liten störande ribonukleinsyra
- Metabola dysfunktionsassocierad steatohepatit (MASH)
- Slutstadiet leversjukdom
- 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)
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Patologiska processer
- Matsmältningssystemets sjukdomar
- Leversjukdomar
- Substansrelaterade störningar
- Kemiskt inducerade störningar
- Alkoholrelaterade störningar
- Leversvikt
- Leverinsufficiens
- Hepatit
- Leversvikt, akut
- Alkohol-inducerade störningar
- Patologiska tillstånd, tecken och symtom
- Alkoholism
- Fibros
- Fet lever
- Alkoholfri fettleversjukdom
- Levercirros
- Hypertoni, Portal
- Slutstadiet leversjukdom
- Akut-på-kronisk leversvikt
- Hepatit, alkoholist
- Levercirros, alkoholist
- Leversjukdomar, alkoholhaltiga
- Fettlever, alkoholhaltig
Andra studie-ID-nummer
- ALN-CIDEB-ALD-25113
- 2026-527097-37-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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
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