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RECRUITINGPHASE2

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

NCT06939816•Enyo Pharma

View on ClinicalTrials.gov

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.

Detailed Description

This is a phase 2, open-label, two-dose, randomized, parallel arms, single center study where subjects are participating for up to 32 weeks: * Screening: 4 weeks * Treatment: 16 weeks * Follow-up: 12 weeks

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed and dated informed consent obtained before any trial-related activities
•Male or female subject.
•Age between 18 and 75 years, both inclusive.
•Overweight or obesity (body mass index BMI ≥ 25.0 kg/m2 and ≤ 45.0 kg/m2) with or without type 2 diabetes mellitus (T2DM with an HbA1c ≤ 9.5%).
•eGFR ≥ 30 and \< 90 (mL/min/1.73 m²).
•Presumed mild to higher liver fibrosis as shown by a FIBROTEST score ≥ 0.28 and/or FIB-4 score ≥ 1.3.

Exclusion Criteria

•Known or suspected hypersensitivity to IMP or any of the excipients or to any component of the IMP formulation.
•Previous participation in this trial. Participation is defined as randomised.
•Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial.
•History of multiple and/or severe allergies to drugs including contrast media or foods or a history of severe anaphylactic reaction.
•Known non-MASH liver disease.
•History or presence of cirrhosis (evidenced on imaging or by histology, or liver decompensation, including ascites, hepatic encephalopathy, or presence of esophageal varices).
•Total body weight loss of \>5% within 6 months prior to screening.
•If female, pregnancy or breast-feeding.
•Women of childbearing potential who are not using a highly effective contraceptive method and whose male partner is not using a highly effective contraceptive method for the entire study duration and for at least 6 weeks after last dosing

Locations (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Key Dates

Start Date

July 1, 2025

Primary Completion Date

April 1, 2026

Completion Date

November 1, 2026

Last Updated

July 4, 2025

Enrollment

ESTIMATED participants

Conditions

Chronic Kidney Disease Stage 2Chronic Kidney Disease Stage 3Metabolic Dysfunction-Associated Steatohepatitis

Interventions

Vonafexor low dose

DRUG

Vonafexor high dose

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of the Link Between MASH ( Metabolic Dysfunction-Associated Steatohepatitis) and MAMs (Mitochondria-Associated Membranes ) Alteration in Patients Undergoing Bariatric Surgery - MAMBA

Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients

Prediction of Peripheral Neuropathy With Functional Testing

Prognostic Factors for HCC and Liver Transplantation in Patients With MASLD/MASH

A Prospective Cohort Study on Patient With Obesity Undergoing Weight Change

A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)