Clinical trial • Phase I • Gastroenterology|Endocrinology

Vonafexor for Healthy volunteers|Renal impairment|Metabolic dysfunction-associated steatohepatitis (MASH)

Phase I trial of Vonafexor for Healthy volunteers|Renal impairment|Metabolic dysfunction-associated steatohepatitis (MASH). 40 participants.

Overview

Trial Therapeutic Area
Gastroenterology|Endocrinology
Trial Disease
Healthy volunteers|Renal impairment|Metabolic dysfunction-associated steatohepatitis (MASH)
Trial Stage
Phase I
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
17-07-2025
First CTIS Authorization Date
09-10-2025

Trial design

Phase I trial across 1 site in France.

Target Sample Size
40

Eligibility

Recruits 40 isVulnerablePopulationSelected: false; no vulnerable population selected.

Vulnerable Population
isVulnerablePopulationSelected: false; no vulnerable population selected

Recruitment

Planned Sample Size
40
Recruitment Window Months
12

Geography

Total Number Of Sites
1
Total Number Of Participants
40

France

Earliest CTIS Part Ii Submission Date
26-09-2025
Latest Decision Or Authorization Date
09-10-2025
Processing Time Days
13
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Eurofins Optimed
Department Name
clinical pharmacology unit
Contact Person Name
Lila KREBS-DROUOT

Sponsor

Primary sponsor

Full Name
ENYO Pharma
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Investigational products

Investigational Product Name
Vonafexor Acid
Active Substance
Vonafexor
Modality
Small molecule
Investigational Product Name
Vonafexor lysine salt (EYP651)
Active Substance
Vonafexor
Modality
Small molecule

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