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

Enyo Pharma

Status and phase

Begins enrollment in 1 month

Phase 2

Conditions

Chronic Kidney Disease Stage 3

Chronic Kidney Disease Stage 2

Metabolic Dysfunction-Associated Steatohepatitis

Treatments

Drug: Vonafexor high dose

Drug: Vonafexor low dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT06939816

EYP001-210

2023-509192-16-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full 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

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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