A Phase 2 interventional study of ALN-CIDEB and Placebo in Alcohol-Associated Liver Disease and ALD, sponsored by Regeneron Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment
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:
73 studies on the registry are indexed under Liver Diseases, Alcoholic; 24 are open to participants now.
This study's planned enrollment of 120 is above the median of 85 across 43 interventional studies indexed under Liver Diseases, Alcoholic.
Browse Liver Diseases, Alcoholic studies →Regeneron Pharmaceuticals is the lead sponsor of 412 studies on the registry; 90 are open to participants now.
Of its 126 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
Drug: ALN-CIDEB
Drug: ALN-CIDEB
Drug: Placebo
Administered per the protocol
Administered per the protocol
Percent Change from Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat fraction (MRI-PDFF)
Time frame: At Week 52
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Through Week 64
Severity of TEAEs
Time frame: Through Week 64
Change from Baseline in Aspartate Aminotransferase (AST)
Time frame: Through Week 64
Change from Baseline in Alanine Aminotransferase (ALT)
Time frame: Through Week 64
Change from Baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE)
Time frame: Through Week 52
Change from Baseline in Enhanced Liver Fibrosis (ELF)
Time frame: Through Week 52
Change from Baseline in FibroScan Controlled Attenuation Parameter (CAP)
Time frame: Through Week 52
No study locations are listed for this record.
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 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
Access criteria: 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
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for May 2029, 28 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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