Recruiting
Phase 3

ALN-CIDEB

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07854782

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

MASLD

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ALN-CIDEB

Placebo

Study Details

Brief 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

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

MASLD

Study ID

NCT07854782

Start date

Oct 28, 2026

Status verified date

Oct, 2026

Completion date

Mar 3, 2029

Anticipated

Primary completion date

Mar 3, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALN-CIDEB Dose Level 1

experimental: ALN-CIDEB Dose Level 2

placebo comparator: Placebo

Interventions

ALN-CIDEB

Administered per the protocol

Placebo

Administered per the protocol

Primary outcome measure

  • Occurrence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Through Week 64 ]
  • Severity of TEAEs [ Time Frame: Through Week 64 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Advanced Medical Trials

Recruiting

Georgetown, Texas, United States, 78628

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.