Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)

Overview

This study will assess the effect of 3 doses of PXL065 versus placebo on liver fat content in NASH patients after 36 weeks of treatment

Full Title of Study: “A 36-week, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Efficacy and Safety of PXL065 Versus Placebo in Noncirrhotic Biopsy-proven NonAlcoholic SteatoHepatitis (NASH) Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 1, 2021

Detailed Description

The study will be performed in patients with NASH. The primary endpoint will be the assessment of the change in the percentage of liver fat content (assessed by MRI-PDFF).

Interventions

  • Drug: PXL065
    • PXL065 oral tablet
  • Drug: Placebo oral tablet
    • Placebo oral tablet

Arms, Groups and Cohorts

  • Experimental: Group 1
    • PXL065 Dose 1
  • Experimental: Group 2
    • PXL065 Dose 2
  • Experimental: Group 3
    • PXL065 Dose 3
  • Placebo Comparator: Group 4
    • Placebo oral tablet

Clinical Trial Outcome Measures

Primary Measures

  • Change in the percentage of liver fat content (assessed by MRI-PDFF)
    • Time Frame: Baseline and week 36

Secondary Measures

  • Assessment of the safety and tolerability
    • Time Frame: Baseline to week 36
    • Adverse Events
  • Liver biospy
    • Time Frame: Baseline and week 36
    • Histology
  • Changes in biological parameters
    • Time Frame: Baseline to week 36
    • Lipids, hsCRP, pro-C3, NFS, ELF, Fib4, insulin resistance indexes

Participating in This Clinical Trial

Inclusion Criteria

  • Patients have given written informed consent
  • Body mass index (BMI) ≤ 50 kg/m²
  • For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or under stable oral glucose lowering drug
  • Estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73m²
  • Liver fat content ≥ 8% on MRI-PDFF
  • Qualifying liver biopsy (NAS) ≥ 4 and fibrosis score F1, F2 or F3)
  • Effective contraception for women of child bearing potential

Exclusion Criteria

  • Evidence of another form of liver disease
  • Evidence of liver cirrhosis
  • Evidence of hepatic impairment
  • Positive serologic evidence of current infectious liver disease
  • History of excessive alcohol intake
  • Acute cardiovascular disease within 6 months prior to Randomization
  • Any disease which in the Investigator's opinion which in the Investigator's opinion would exclude the patient from the study
  • Use of non-permitted concomitant medication
  • Pregnancy or lactation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Poxel SA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Emeline Kieken, +33 6 63 49 38 26, emeline.kieken@poxelpharma.com

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