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Melanotan-2

MT-II, Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2

Quick Stats
Studies 3
Trials 100
Recruiting PHASE2 INTERVENTIONAL NCT05519475

A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This study is researching an investigational drug, ALN-HSD called "study drug". This study is focused on participants who are known to have metabolic dysfunction-associated steatohepatitis (MASH). MASH is a form of metabolic dysfunction-associated steatotic liver disease (MASLD). MASH occurs when fat builds up in liver cells, damaging them, and making the liver inflamed and stiff from fibrosis (scar tissue). MASH can progress to cirrhosis (long term scarring) and liver failure (when the liver cannot perform its job). The aim of the study is to see the effect of the study drug on lessening liver scarring side effects related to MASH. The study is looking at several other research questions, including: * How ALN-HSD works to improve liver function and lessen MASH-related inflammation in the liver * What side effects may happen from receiving the study drug * How much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in the blood at different times * Better understanding of the study drug and MASH

Interventions

Name: ALN-HSD
Type: DRUG
Description: Administered by subcutaneous injection (SC)
Name: Placebo
Type: DRUG
Description: Administered by SC injection

Primary Outcomes

Measure: Change in qFibrosis
TimeFrame: Baseline to week 52
Description: Change in the continuous quantitative liver fibrosis (qFibrosis) score measured by second harmonic generation/two-photon excitation microscopy

Trial Information

NCT ID

NCT05519475

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Regeneron Pharmaceuticals

Last Updated

December 15, 2025