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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03763877
Other study ID # PXL770-004
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 29, 2019
Est. completion date August 10, 2020

Study information

Verified date October 2021
Source Poxel SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date August 10, 2020
Est. primary completion date August 3, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PXL770
Oral capsule
Placebo Oral Capsule
Oral capsule

Locations

Country Name City State
United States Study Site 06 Arlington Texas
United States Study Site 10 Athens Georgia
United States Study Site 08 Berlin New Jersey
United States Study Site 09 Durham North Carolina
United States Study Site 01 Gainesville Florida
United States Study Site 03 Indianapolis Indiana
United States Study Site 02 Los Angeles California
United States Study Site 07 Marrero Louisiana
United States Study Site 11 Ocoee Florida
United States Study Site 15 Orlando Florida
United States Study Site 13 Rapid City South Dakota
United States Study Site 14 Richmond Virginia
United States Study Site 04 San Antonio Texas
United States Study Site 12 San Antonio Texas
United States Study Site 05 West Monroe Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Poxel SA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 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. Baseline to Week 12
Primary 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) 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. Baseline to Week 12
Primary 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) 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. Baseline to Week 12
Primary 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]) 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. Baseline to Week 12
Secondary Absolute Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment 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. Baseline to Week 12
Secondary Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment 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 Baseline to Week 12
Secondary Change in Alanine Amino Transferase (ALT) From Baseline to Week 12/End of Treatment 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. Baseline to Week 12
Secondary Change in Aspartate Amino Transferase (AST) From Baseline to Week 12/End of Treatment 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. Baseline to Week 12
Secondary Change in Fasting Plasma Glucose (FPG) From Baseline to Week12/End of Treatment 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. Baseline to Week 12
Secondary Change in Glycated Hemoglobin (HbA1c) From Baseline to Week12/End of Treatment 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. Baseline to Week 12
Secondary Change in Total Cholesterol From Baseline to Week12/End of Treatment 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. Baseline to Week 12
Secondary Change in High Density Lipoprotein-Cholesterol (HDL-C) From Baseline to Week12/End of Treatment 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. Baseline to Week 12
Secondary Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Week12/End of Treatment 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. Baseline to Week 12
Secondary Change in Triglycerides From Baseline to Week12/End of Treatment 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. Baseline to Week 12
Secondary Change in Fibrosis-4 (Fib-4) Score From Baseline to Week 12/End of Treatment 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] × v[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.
Baseline to Week 12
Secondary Change in Body Weight From Baseline to Week 12/End of Treatment 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. Baseline to Week 12
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