Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-asso… (NCT06939816) | Clinical Trial Compass
TerminatedPhase 2
Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis)
Stopped: Pilot cohort (n=10) yielded useful insights but data remains exploratory due to limited sample size. Study stopped due to strategic reprioritization.
Germany10 participantsStarted 2025-07-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 contracepti…