Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis)
Phase 2
Not yet recruiting
- Conditions
- Chronic Kidney Disease Stage 2Metabolic Dysfunction-Associated SteatohepatitisChronic Kidney Disease Stage 3
- Interventions
- Drug: Vonafexor low doseDrug: Vonafexor high dose
- Registration Number
- NCT06939816
- Lead Sponsor
- Enyo Pharma
- 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) 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.
- 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 weeks
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vonafexor low dose Vonafexor low dose Vonafexor low dose 1 tablet per day Vonafexor high dose Vonafexor high dose Vonafexor high dose 1 tablet per day
- Primary Outcome Measures
Name Time Method Change from baseline of mGFRiohexol at week 16 16 weeks Change from baseline of eGFRcreatinine at week 16 16 weeks
- Secondary Outcome Measures
Name Time Method Vonafexor plasma concentrations 16 weeks Plasma concentrations pre-dose and post-dose which will be modelled against the MASH PopPK expected values
Change from baseline mGFRiohexol off treatment at week 24 24 weeks Change from baseline of eGFRcreatinine on treatment at weeks 4, 8, 12 and off treatment at weeks 20, 24 and 28 28 weeks Correlation of mGFRiohexol with eGFRcreatinine at baseline, on treatment at week 16 and off treatment at week 24 24 weeks Levels and change in proteinuria in morning urine samples at baseline, on treatment at weeks 4, 8, 12, 16 with off treatment at weeks 20, 24 and 28 28 weeks Treatment-emergent adverse events and serious adverse events 28 weeks
Trial Locations
- Locations (1)
Profil Institut für Stoffwechselforschung GmbH
🇩🇪Neuss, Germany