Clinical Trials Logo
  1. Home
  2. Non-Alcoholic Steatohepatitis
  3. NCT03812029

Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH)

Non-alcoholic Steatohepatitis Clinical Trial

Official title:
A Phase 2a, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis

Clinical Trial 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

Clinical Trial Description

This is a 2-part, randomized, double-blind, multicenter, placebo-controlled study to evaluate the safety and efficacy of Vonafexor in patients with NASH who likely have stage F2 to F3 fibrosis at approximately 50 global clinical sites. Overall, approximately 114 eligible patients will be enrolled: 24 patients in Part A (Safety Run-in Cohort), followed by 90 patients in Part B. In Part A, 24 patients will be randomized on Day 1 to 1 of 4 parallel treatment groups: 100 mg Vonafexor twice daily (BID), 200 mg Vonafexor once daily (QD), 400 mg Vonafexor QD, or placebo BID. In Part B, 90 patients will be randomized on Day 1 to 1 of 3 parallel treatment groups: 100 mg Vonafexor QD, 200 mg Vonafexor QD, or placebo QD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03812029
Study type Interventional
Source Enyo Pharma
Contact
Status Completed
Phase Phase 2
Start date January 30, 2019
Completion date July 6, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05945537 - A Study of INI-822 in Healthy Volunteers and Participants With Non-alcoholic Steatohepatitis (NASH) or Presumed NASH Phase 1
Recruiting NCT05462353 - Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH Phase 2
Recruiting NCT05065593 - The Effect of Aerobic and Resistant Exercise Training in Patients With Non-Alcoholic Steatohepatitis N/A
Terminated NCT04171765 - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis Phase 2
Recruiting NCT04365855 - The Olmsted NAFLD Epidemiology Study (TONES) N/A
Active, not recruiting NCT02912260 - Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH) Phase 2
Recruiting NCT06054815 - Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH Phase 2
Completed NCT02784444 - A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH Phase 2
Not yet recruiting NCT06160271 - Study of Liver Fibrosis Stage Assessment by Fibroblast Activation Protein Imaging in Patients With Biopsy for Suspected or Proven Nonalcoholic Steatohepatitis Phase 2
Active, not recruiting NCT05573204 - Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients With Non-alcoholic Steatohepatitis Phase 2
Completed NCT04042142 - Glucagon Resistance in Patients With NAFLD N/A
Completed NCT04657523 - Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study N/A
Completed NCT04142424 - A Study to Understand the Safety, Tolerability, and Activity of Drug in Body Over a Period of Time of AZD2693, in Subjects of Non-Childbearing Potential in Overweight But Otherwise Healthy Subjects, and Healthy Chinese and Japanese Subjects Phase 1
Terminated NCT02787304 - Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH) Phase 2
Recruiting NCT04666402 - Integrated Diagnostics for Early Diagnosis of Liver Disease
Completed NCT02528305 - The Effect of HIT in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis N/A
Recruiting NCT01056133 - Effect of Fish-oil on Non-alcoholic Steatohepatitis (NASH) Phase 2
Completed NCT04806750 - Emricasan, an Oral Caspase Inhibitor, in Subjects With Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension Phase 2
Completed NCT02960204 - Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension Phase 2
Recruiting NCT05751720 - Effect on Non-Alcoholic Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus With Gastric Inhibitory Polypeptide/Glucagon Like Peptide-1 Analogue Phase 1/Phase 2