Recruiting
Phase 1
Phase 2

ALN-CIDEB

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT06836609

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Metabolic Dysfunction-Associated Steatohepatitis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ALN-CIDEB

Placebo

Study Details

Brief summary:

This study is researching an experimental drug called ALN-CIDEB, also referred to as "study drug". The study is focused on participants with metabolic dysfunction-associated steatotic liver disease (MASLD) (Part A) and metabolic dysfunction-associated steatohepatitis (MASH) (Part B). MASLD and MASH are long-lasting liver conditions caused by having too much fat in the liver.

The aim of the study is to see how safe and tolerable the study drug is.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug
  • How the study drug works to change liver fat content
  • How much study drug and study drug metabolites (byproducts of the body breaking down the study drug) are in the blood at different times

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Metabolic Dysfunction-Associated Steatohepatitis

Study ID

NCT06836609

Start date

Apr 28, 2025

Status verified date

Jul, 2026

Completion date

May 15, 2027

Anticipated

Primary completion date

May 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Part A: 18 to 55 years at Screening Visit 1 with MASLD, at Screening Visit 1 Part B: 18 to 65 years at Screening Visit 1 with a diagnosis of MASH, at Screening Visit 1
2. Body Mass Index (BMI) ≥30 kg/m2 and ≤40 kg/m2 at Screening Visit 1
3. Controlled-Attenuation Parameter (CAP) ≥285 dB/m by FibroScan during screening as described in the protocol
4. Liver fat content ≥8.5% by MRI-PDFF during screening
5. If on anti-hypertensive and/or lipid lowering medications and/or glucose lowering medications, must be on generally stable dose(s) for at least 12 weeks prior to screening and no changes to the dose(s) are anticipated during the study
6. Part B: A diagnosis of MASH documented in the participant's medical history, or a clinical suspicion of MASH based on non-invasive biomarkers (eg, evidence of fatty liver on imaging and elevated liver enzymes) and clinical risk factors, including having a history of 2 or more elements of metabolic syndrome, as defined in the protocol
7. Part B: Screening percutaneous liver biopsy NAFLD Activity Score (NAS) ≥3 and fibrosis stage, as defined in the protocol

Key Exclusion Criteria:

1. Known historical or current diagnosis of portal hypertension or cirrhosis based on clinical assessment, imaging, and/or liver biopsy
2. Known historical or current diagnosis of other forms of chronic liver disease, as defined in the protocol
3. Prior or current suspected or known drug-induced liver injury within 1 year prior to screening
4. History of liver transplant, current placement on a liver transplant list, or Model for End-stage Liver Disease (MELD) score >12
5. Contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions, or other contraindications for MRI
6. Liver stiffness measurement, laboratory parameter assessment, estimated Glomerular Filtration Rate (GFR), and evidence of uncontrolled hypertension, as defined in the protocol
7. Evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B Virus (HBV) infection, or Hepatitis C Virus (HCV) infection during screening, as described in the protocol
8. History of Type 1 Diabetes
9. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions, within approximately 5 years prior to randomization or planned during the study period

NOTE: Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A

Randomized per the protocol

experimental: Part B

Randomized per the protocol

Interventions

ALN-CIDEB

Administered per the protocol

Placebo

Administered per the protocol

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 48 Weeks ]
  • Severity of TEAEs [ Time Frame: Up to 48 Weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Arizona Liver Health

Recruiting

Chandler, Arizona, United States, 85225

Adobe Clinical Research

Recruiting

Tucson, Arizona, United States, 85712

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Obese
  • MASLD
  • MASH

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-07-08.