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Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04321343
Recruitment Status : Not yet recruiting
First Posted : March 25, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Poxel SA

Brief Summary:
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

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Drug: PXL065 Drug: Placebo oral tablet Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 19, 2021


Arm Intervention/treatment
Experimental: Group 1
PXL065 Dose 1
Drug: PXL065
PXL065 oral tablet

Experimental: Group 2
PXL065 Dose 2
Drug: PXL065
PXL065 oral tablet

Experimental: Group 3
PXL065 Dose 3
Drug: PXL065
PXL065 oral tablet

Placebo Comparator: Group 4
Placebo oral tablet
Drug: Placebo oral tablet
Placebo oral tablet




Primary Outcome Measures :
  1. Change in the percentage of liver fat content (assessed by MRI-PDFF) [ Time Frame: Baseline and week 36 ]

Secondary Outcome Measures :
  1. Assessment of the safety and tolerability [ Time Frame: Baseline to week 36 ]
    Adverse Events

  2. Liver biospy [ Time Frame: Baseline and week 36 ]
    Histology

  3. Changes in biological parameters [ Time Frame: Baseline to week 36 ]
    Lipids, hsCRP, pro-C3, NFS, ELF, Fib4, insulin resistance indexes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321343


Contacts
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Contact: Emeline Kieken +33 6 63 49 38 26 emeline.kieken@poxelpharma.com

Sponsors and Collaborators
Poxel SA

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Responsible Party: Poxel SA
ClinicalTrials.gov Identifier: NCT04321343    
Other Study ID Numbers: PXL065-003
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases