RecruitingPhase 1Phase 2NCT06836609

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Two Doses of ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)


Sponsor

Regeneron Pharmaceuticals

Enrollment

132 participants

Start Date

Apr 28, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ALN-CIDEB and a drug called Placebo for people with metabolic dysfunction-associated steatohepatitis and metabolic dysfunction-associated steatotic liver disease. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALN-CIDEB

Administered per the protocol

DRUGPlacebo

Administered per the protocol


Locations(4)

Arizona Liver Health

Chandler, Arizona, United States

Adobe Clinical Research

Tucson, Arizona, United States

Richmond Pharmacology Limited

London, Greater London, United Kingdom

Parexel International Early Phase Clinical Unit

Harrow, London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06836609


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