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Not yet recruitingNCT07854782Updated Oct 2, 2026

Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

A Phase 3 interventional study of ALN-CIDEB and Placebo in Metabolic Dysfunction-Associated Steatotic Liver Disease and MASLD, sponsored by Regeneron Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment

Updated Oct 2, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
1,500
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH). MASH is more advanced stage of a broader liver disease, MASLD. MASLD is a liver condition caused by too much fat building up in the liver. This can lead to liver scarring and inflammation and can reduce the liver's ability to keep the body healthy. Cell death-inducing DFFA-like effector B (CIDEB) is a protein made by liver cells that helps the liver to store fat.

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 ALN-CIDEB could affect the body and the liver, which can help researchers understand why ALN-CIDEB works better for some people than others
02

Conditions studied

  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • MASLD

Keywords

  • NAFLD
  • NASH
  • Metabolic Dysfunction-Associated Steatohepatitis
  • MASH
  • Fatty Liver Disease
  • Non-alcoholic Fatty Liver Disease
  • Liver Fibrosis
  • Steatotic Liver Disease
  • SLD
  • Metabolic Fatty Liver Disease
  • Hepatic Steatosis
  • Fatty Liver
  • Liver Fat
  • Excess Liver Fat
  • Obesity
  • Insulin Resistance
03

In context

Non-alcoholic Fatty Liver Disease

1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Has a clinical diagnosis of MASLD, as defined in the protocol
  2. Has a liver stiffness measurement between 6 and 20 kilopascals (kPa), as measured by a FibroScan® scan during screening or within approximately 3 months of screening, as defined in the protocol

Key Exclusion Criteria:

  1. Has a known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol
  2. Has prior or current suspected or known drug-induced liver injury within approximately 1 year prior to screening
  3. Has a history of liver transplantation, current placement on a liver transplant list, or Model for End-Stage Liver Disease (MELD) score >12
  4. Has a known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion
  5. Has prior, current, or planned future use (during the treatment period) of a GLP-1 receptor agonist-based therapy or any medication approved for the treatment of MASH (eg, resmetirom) unless used at a generally stable dose and regimen since at least 3 months prior to screening visit and throughout the screening period with no change to the dose or regimen anticipated during the treatment period, as defined in the protocol
  6. Has evidence of uncontrolled human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection during screening, as defined in the protocol

NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,500 participants (estimated)

Study arms

  • Experimental
    ALN-CIDEB Dose Level 1

    Drug: ALN-CIDEB

  • Experimental
    ALN-CIDEB Dose Level 2

    Drug: ALN-CIDEB

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugALN-CIDEB

    Administered per the protocol

  • DrugPlacebo

    Administered per the protocol

06

What researchers measure

Primary outcomes

  1. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Through Week 64

  2. Severity of TEAEs

    Time frame: Through Week 64

Secondary outcomes

  1. Change from Baseline in FibroScan Controlled Attenuation Parameter (CAP)

    Time frame: At Week 52

  2. Change from Baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE)

    Time frame: At Week 52

  3. Change from Baseline in Aspartate Aminotransferase (AST)

    Time frame: Through Week 64

  4. Change from Baseline in Alanine Aminotransferase (ALT)

    Time frame: Through Week 64

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07854782
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 2, 2026
Start date
Nov 6, 2026 (estimated)
Primary completion
Mar 3, 2029 (estimated)
Completion
Mar 3, 2029 (estimated)
Last update
Oct 2, 2026

Study contacts

Clinical Trials Administrator
Contact
clinicaltrials@regeneron.com
844-734-6643
Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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