Status:
RECRUITING
Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis)
Lead Sponsor:
Enyo Pharma
Conditions:
Chronic Kidney Disease Stage 2
Chronic Kidney Disease Stage 3
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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) an...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06939816
Start Date
July 1 2025
End Date
November 1 2026
Last Update
July 4 2025
Active Locations (1)
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1
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460