A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)

NCT06836609 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ALN-CIDEB-NASH-2486
• Study Type: interventional
• Target: 132
• Locations: 2 countries
• Sites: 3

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

Keywords

Obese; MASLD; MASH

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  Up to 48 Weeks

• Severity of TEAEs

  Up to 48 Weeks

Secondary Outcomes (8)

• Change in liver fat fraction by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)

  Baseline up to 48 Weeks

• Total concentration of ALN-CIDEB in plasma

  Up to 48 Weeks

• Total concentration of potential major metabolite(s) in plasma

  Up to 48 Weeks

• Urinary recovery of ALN-CIDEB as a proportion of the dose

  Up to 36 Weeks

• Urinary recovery of potential major metabolite(s) as a proportion of the dose

  Up to 36 Weeks

Study Arms (2)

Part A

EXPERIMENTAL

Randomized per the protocol

Drug: ALN-CIDEB; Drug: Placebo

Part B

EXPERIMENTAL

Randomized per the protocol

Drug: ALN-CIDEB; Drug: Placebo

Interventions

ALN-CIDEB DRUG

Administered per the protocol

Part A; Part B

Placebo DRUG

Administered per the protocol

Part A; Part B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Body Mass Index (BMI) ≥30 kg/m2 and ≤40 kg/m2 at Screening Visit 1
• Controlled-Attenuation Parameter (CAP) ≥285 dB/m by FibroScan during screening as described in the protocol
• Liver fat content ≥8.5% by MRI-PDFF during screening
• 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
• 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
• Part B: Screening percutaneous liver biopsy NAFLD Activity Score (NAS) ≥3 and fibrosis stage, as defined in the protocol

You may not qualify if:

• Known historical or current diagnosis of portal hypertension or cirrhosis based on clinical assessment, imaging, and/or liver biopsy
• Known historical or current diagnosis of other forms of chronic liver disease, as defined in the protocol
• Prior or current suspected or known drug-induced liver injury within 1 year prior to screening
• History of liver transplant, current placement on a liver transplant list, or Model for End-stage Liver Disease (MELD) score \>12
• Contraindication to MRI examinations, such as persons with cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions, or other contraindications for MRI
• Liver stiffness measurement, laboratory parameter assessment, estimated Glomerular Filtration Rate (GFR), and evidence of uncontrolled hypertension, as defined in the protocol
• 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
• History of Type 1 Diabetes
• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (3)

Arizona Liver Health

Chandler, Arizona, 85225, United States

RECRUITING

Richmond Pharmacology Limited

London, Greater London, SE1 1YR, United Kingdom

RECRUITING

Parexel International Early Phase Clinical Unit

Harrow, London, HA1 3UJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase: 1 ex-US Phase: 1/2a in US only Part A: Sequential and Part B: Parallel

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 20, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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

Locations

GB (2); US (1)