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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-11-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vonafexor low dose

Vonafexor low dose 1 tablet per day

Group Type EXPERIMENTAL

Vonafexor low dose

Intervention Type DRUG

Oral tablets

Vonafexor high dose

Vonafexor high dose 1 tablet per day

Group Type EXPERIMENTAL

Vonafexor high dose

Intervention Type DRUG

Oral tablets

Interventions

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Vonafexor low dose

Oral tablets

Intervention Type DRUG

Vonafexor high dose

Oral tablets

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No