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FXR Agonist

Vonafexor 100 mg BID for Non-alcoholic Fatty Liver Disease

Phase 2
Waitlist Available
Led By Harrison Stephen, MD
Research Sponsored by Enyo Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

The purpose of this study is to assess the effects of EYP001a (Vonafexor) with respect to safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with NASH

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analysis of Absolute Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Secondary outcome measures
Analysis of Change From Baseline in Glomerular Filtration rate_Part A
Analysis of Percent Change (Relative) From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)

Side effects data

From 2021 Phase 2 trial • 120 Patients • NCT03812029
67%
Pruritus
15%
Nausea
12%
Diarrhoea
9%
Limb injury
9%
Hypercholesterolaemia
6%
Skin lesion
6%
Vomiting
6%
Depression
6%
Insomnia
6%
Transaminases increased
6%
Headache
3%
Constipation
3%
Urinary tract infection
3%
Cough
3%
Paraesthesia
3%
COVID-19
3%
Hypertension
3%
Abdominal pain
3%
Abdominal rigidity
3%
Type 2 diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vonafexor 200 mg QD Part B
Vonafexor 100 mg QD Part B
Placebo Part A
Vonafexor 100 mg BID Part A
Vonafexor 200 mg QD Part A
Vonafexor 400 mg QD Part A
Placebo Part B

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Vonafexor 400 mg QDExperimental Treatment1 Intervention
Oral dose once daily for 12 weeks (84 days)
Group II: Vonafexor 200 mg QDExperimental Treatment1 Intervention
Oral dose once daily for 12 weeks (84 days)
Group III: Vonafexor 100 mg QDExperimental Treatment1 Intervention
Oral dose once daily for 12 weeks (84 days)
Group IV: Vonafexor 100 mg BIDExperimental Treatment1 Intervention
Oral dose twice daily for 12 weeks (84 days)
Group V: PlaceboPlacebo Group1 Intervention
Oral dose twice daily for 12 weeks (84 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vonafexor
2019
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Enyo PharmaLead Sponsor
9 Previous Clinical Trials
268 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
16 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Harrison Stephen, MDPrincipal InvestigatorPinnacle Clinical Research
~18 spots leftby Sep 2025
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