Vonafexor fixed dose-escalation safety and proof-of-concept study in patients with at risk of progression Alport syndrome

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509638-20-00

Acronym

EYP001-208

Enrollment

Registered

2024-08-20

Start date

2024-09-30

Completion date

2025-09-30

Last updated

2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alport Syndrome

Brief summary

Number of Treatment-Emergent Adverse Event (TEAE) from first dose of treatment until 2 weeks after last dose of treatment, Change in physical examinations, vital signs, laboratory variables and lipid profile at on-treatment and off-treatment periods compared to baseline.

Detailed description

Change in eGFR response at applicable visits during on-treatment and off-treatment periods compared to baseline, Vonafexor plasma concentrations levels at on-treatment applicable visits compared to expected concentrations based on a vonafexor Population Pharmacokinetic (PK) model.

Interventions

DRUGVonafexor

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Number of Treatment-Emergent Adverse Event (TEAE) from first dose of treatment until 2 weeks after last dose of treatment, Change in physical examinations, vital signs, laboratory variables and lipid profile at on-treatment and off-treatment periods compared to baseline.	—

Secondary

Measure	Time frame
Change in eGFR response at applicable visits during on-treatment and off-treatment periods compared to baseline, Vonafexor plasma concentrations levels at on-treatment applicable visits compared to expected concentrations based on a vonafexor Population Pharmacokinetic (PK) model.	—

Countries

France, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026