Nonalcoholic Fatty Liver Clinical Trial
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
Verified date | October 2021 |
Source | Poxel SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Poxel SA |
United States,
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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