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A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03763877
Recruitment Status : Completed
First Posted : December 4, 2018
Results First Posted : October 28, 2021
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
Poxel SA

Brief Summary:
This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Drug: PXL770 Drug: Placebo Oral Capsule Phase 2

Detailed Description:
The study will be performed in patients with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of the change in the percentage of liver fat mass (assessed by MRI-PDFF).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
Actual Study Start Date : March 29, 2019
Actual Primary Completion Date : August 3, 2020
Actual Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
PXL770 Dose 1
Drug: PXL770
Oral capsule

Experimental: Group 2
PXL770 Dose 2
Drug: PXL770
Oral capsule

Experimental: Group 3
PXL770 Dose 3
Drug: PXL770
Oral capsule

Placebo Comparator: Group 4
Placebo oral capsule
Drug: Placebo Oral Capsule
Oral capsule




Primary Outcome Measures :
  1. Relative Change in the Percentage of Liver Fat Mass (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF]) From Baseline to Week 12/End of Treatment (EOT) [ Time Frame: Baseline to Week 12 ]
    MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 region of interest (ROI) was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.

  2. Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Per Protocol Sensitivity Analysis) [ Time Frame: Baseline to Week 12 ]
    MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.

  3. Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Unstratified Wilcoxon Sensitivity Analysis) [ Time Frame: Baseline to Week 12 ]
    MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.

  4. Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Subgroup Analysis - Type 2 Diabetes Mellitus [T2DM]) [ Time Frame: Baseline to Week 12 ]
    MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.


Secondary Outcome Measures :
  1. Absolute Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment [ Time Frame: Baseline to Week 12 ]
    MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.

  2. Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment [ Time Frame: Baseline to Week 12 ]
    Responders were defined as patients who achieved a clinically meaningful relative reduction of at least 30% in liver fat mass From baseline to Week 12/EOT as assessed by MRI-PDFF

  3. Change in Alanine Amino Transferase (ALT) From Baseline to Week 12/End of Treatment [ Time Frame: Baseline to Week 12 ]
    Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

  4. Change in Aspartate Amino Transferase (AST) From Baseline to Week 12/End of Treatment [ Time Frame: Baseline to Week 12 ]
    Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

  5. Change in Fasting Plasma Glucose (FPG) From Baseline to Week12/End of Treatment [ Time Frame: Baseline to Week 12 ]
    Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

  6. Change in Glycated Hemoglobin (HbA1c) From Baseline to Week12/End of Treatment [ Time Frame: Baseline to Week 12 ]
    Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

  7. Change in Total Cholesterol From Baseline to Week12/End of Treatment [ Time Frame: Baseline to Week 12 ]
    Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

  8. Change in High Density Lipoprotein-Cholesterol (HDL-C) From Baseline to Week12/End of Treatment [ Time Frame: Baseline to Week 12 ]
    Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

  9. Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Week12/End of Treatment [ Time Frame: Baseline to Week 12 ]
    Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

  10. Change in Triglycerides From Baseline to Week12/End of Treatment [ Time Frame: Baseline to Week 12 ]
    Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.

  11. Change in Fibrosis-4 (Fib-4) Score From Baseline to Week 12/End of Treatment [ Time Frame: Baseline to Week 12 ]

    Fib-4 score is a non invasive method based on clinical determinations that indicates the level of fibrosis/ scarring of the liver. The set cutoffs for this scoring are: Fib-4 < 1.45: absence of cirrhosis; Fib-4 between 1.45 - 3.25: inconclusive and Fib-4 > 3.25: cirrhosis.

    Fib-4 score was calculated as (Age [years] × AST [U/L]) / (platelet [10^9/L] × √[ALT [U/L]]). Blood samples used for AST, ALT and platelet counts were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.


  12. Change in Body Weight From Baseline to Week 12/End of Treatment [ Time Frame: Baseline to Week 12 ]
    Body weight was measured using a scale with appropriate resolution, placed on a stable, flat surface. Shoes, bulky layers of clothing, and jackets had to be removed so that only light clothing remained.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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) ≥ 25 to ≤ 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) ≥ 60 mL/[min*1.73m²]
  • Alanine amino transferase (ALT) > 20 IU/L in females and > 30 IU/L in males
  • Hepatic steatosis (MRI-PDFF ≥ 10%)
  • 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 with 24 weeks prior to screening
  • Uncontrolled high blood pressure
  • 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): NCT03763877


Locations
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United States, California
Study Site 02
Los Angeles, California, United States, 90057
United States, Florida
Study Site 01
Gainesville, Florida, United States, 32610
Study Site 11
Ocoee, Florida, United States, 34761
Study Site 15
Orlando, Florida, United States, 32804
United States, Georgia
Study Site 10
Athens, Georgia, United States, 30607
United States, Indiana
Study Site 03
Indianapolis, Indiana, United States, 46260
United States, Louisiana
Study Site 07
Marrero, Louisiana, United States, 70072
Study Site 05
West Monroe, Louisiana, United States, 71291
United States, New Jersey
Study Site 08
Berlin, New Jersey, United States, 08009
United States, North Carolina
Study Site 09
Durham, North Carolina, United States, 27710
United States, South Dakota
Study Site 13
Rapid City, South Dakota, United States, 57701
United States, Texas
Study Site 06
Arlington, Texas, United States, 76012
Study Site 04
San Antonio, Texas, United States, 78207
Study Site 12
San Antonio, Texas, United States, 78215
United States, Virginia
Study Site 14
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Poxel SA
  Study Documents (Full-Text)

Documents provided by Poxel SA:
Study Protocol  [PDF] July 24, 2020
Statistical Analysis Plan  [PDF] September 15, 2020

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Poxel SA
ClinicalTrials.gov Identifier: NCT03763877    
Other Study ID Numbers: PXL770-004
First Posted: December 4, 2018    Key Record Dates
Results First Posted: October 28, 2021
Last Update Posted: October 28, 2021
Last Verified: October 2021

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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