NCT06939816TerminatedPhase 2
Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis)
A Study to Assess the Effect of Vonafexor on Kidney Function in Subjects With Impaired Renal Function and Suspected MASH
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Reason given: Pilot cohort (n=10) yielded useful insights but data remains exploratory due to limited sample size. Study stopped due to strategic reprioritization.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 7 Apr 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 22 Dec 2025
- Lead sponsor
- Enyo Pharma
- NCT number
- NCT06939816
- EU CT number
- 2023-509192-16-00
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in this trial. Participation is defined as randomised.
- Total body weight loss of >5% within 6 months prior to screening.
Other illness
- Known or suspected hypersensitivity to IMP or any of the excipients or to any component of the IMP formulation.
- 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.
Other
- 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 or presence of cirrhosis (evidenced on imaging or by histology, or liver decompensation, including ascites, hepatic encephalopathy, or presence of esophageal varices).
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.