Trials / Recruiting
RecruitingNCT06939816
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Enyo Pharma · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Chronic Kidney Disease Stage 2
- Chronic Kidney Disease Stage 3
- Metabolic Dysfunction-Associated Steatohepatitis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vonafexor low dose | Oral tablets |
| DRUG | Vonafexor high dose | Oral tablets |
Timeline
- Start date
- 2025-07-01
- Primary completion
- 2026-04-01
- Completion
- 2026-11-01
- First posted
- 2025-04-23
- Last updated
- 2025-07-04
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT06939816. Inclusion in this directory is not an endorsement.