RecruitingPhase 2NCT06939816

Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis)

A Study to Assess the Effect of Vonafexor on Kidney Function in Subjects With Impaired Renal Function and Suspected MASH


Sponsor

Enyo Pharma

Enrollment

60 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is designed to establish the effect of 2 doses of vonafexor on the kidney. This will be investigated in subjects with mild or moderate reduced estimated glomerular filtration rate (eGFR) and suspected MASH. In addition, the non-invasive multiparametric magnetic resonance imaging assessment of functional and structural changes in the kidney and in the liver will be investigated.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called vonafexor for people who have both impaired kidney function and suspected MASH (metabolic dysfunction-associated steatohepatitis — a form of fatty liver disease that causes inflammation and scarring). MASH is increasingly common in people with obesity and diabetes, and there are few approved treatments. **You may be eligible if...** - You are between 18 and 75 years old - You are overweight or obese (BMI 25–45) - Your kidney function is reduced but not severely so (eGFR 30–90) - You have signs of mild-to-moderate liver scarring based on specific blood tests - You may have type 2 diabetes with controlled blood sugar levels **You may NOT be eligible if...** - You have known liver disease other than fatty liver (MASH) - You have cirrhosis (advanced liver scarring) or signs of liver failure - You have lost more than 5% of your body weight in the last 6 months - You are pregnant or breastfeeding - You have had a severe allergic reaction to drugs or foods in the past - You have recently participated in another clinical trial Talk to your doctor to see if this trial is right for you.

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

DRUGVonafexor low dose

Oral tablets

DRUGVonafexor high dose

Oral tablets


Locations(1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

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NCT06939816


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