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

NCT06939816 | Terminated Phase 2

• 2 other identifiers: EYP001-2102023-509192-16-00
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

CKD; Chronic Kidney Disease; MASH; Metabolic Dysfunction-Associated Steatohepatitis; Kidney function; eGFR; estimated Glomerular function rate; mGFR; measured Glomerular function rate

Outcome Measures

Primary Outcomes (2)

• Change from baseline of mGFRiohexol at week 16

  16 weeks

• Change from baseline of eGFRcreatinine at week 16

  16 weeks

Secondary Outcomes (6)

• Vonafexor plasma concentrations

  16 weeks

• Change from baseline mGFRiohexol off treatment at week 24

  24 weeks

• Change from baseline of eGFRcreatinine on treatment at weeks 4, 8, 12 and off treatment at weeks 20, 24 and 28

  28 weeks

• Correlation of mGFRiohexol with eGFRcreatinine at baseline, on treatment at week 16 and off treatment at week 24

  24 weeks

• Levels and change in proteinuria in morning urine samples at baseline, on treatment at weeks 4, 8, 12, 16 with off treatment at weeks 20, 24 and 28

  28 weeks

Other Outcomes (3)

• MRI kidney biomarkers time course from baseline, to on treatment at week 16 and to off treatment at week 24

  24 weeks

• MRI liver biomarkers time course from baseline, to on treatment at week 16 and to off treatment at week 24

  24 weeks

• Liver biomarker FIB-4 changes from baseline at on treatment week 8, 16 and off treatment at week 24

  24 weeks

Study Arms (2)

Vonafexor low dose

EXPERIMENTAL

Vonafexor low dose 1 tablet per day

Drug: Vonafexor low dose

Vonafexor high dose

EXPERIMENTAL

Vonafexor high dose 1 tablet per day

Drug: Vonafexor high dose

Interventions

Vonafexor low dose DRUG

Oral tablets

Vonafexor low dose

Vonafexor high dose DRUG

Oral tablets

Vonafexor high dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Enyo Pharma: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 23, 2025
• Study Start: July 1, 2025
• Primary Completion: December 22, 2025
• Study Completion: March 13, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)