Skip to main content
OpenTrials
Completed

NCT Number: NCT03763877

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nonalcoholic Fatty Liver Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Study Site 02, Los Angeles, California, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PXL770

Drug

Oral capsule

Placebo oral capsule

Drug

Oral capsule

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Poxel SA

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2018
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.