Phase 2
Completed N=121
A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
Nonalcoholic Fatty Liver
Source: ClinicalTrials.gov NCT03763877 ↗
Enrolled (actual)
121
Serious AEs
2.5%
Results posted
Oct 2021
Primary outcomePrimary: 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) — -1.14; -1.03; -14.28; -14.68 percentage — p=0.9883
Summary
This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
-1.14; -1.03; -14.28; -14.68 | 0.9883 |
| 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) |
-0.69; -2.27; -13.94; -18.00 | 0.8283 |
| 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) |
0.49; 1.44; -8.32; -15.29 | 0.5537 |
| 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]) |
-6.11; 1.15; -16.71; -27.24 | 0.5733 |
| SECONDARY Absolute Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment |
0.023; -0.218; -2.548; -2.391 | 0.8617 |
| SECONDARY Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment |
2; 4; 4; 8; 25; 22 | 0.5592 |
| SECONDARY Change in Alanine Amino Transferase (ALT) From Baseline to Week 12/End of Treatment |
1.0; 0.0; 0.3; -6.3 | 0.8013 |
| SECONDARY Change in Aspartate Amino Transferase (AST) From Baseline to Week 12/End of Treatment |
-2.8; -1.7; -2.2; -7.0 | 0.6681 |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week12/End of Treatment |
0.36; 0.19; -0.17; -0.16 | 0.5148 |
| SECONDARY Change in Glycated Hemoglobin (HbA1c) From Baseline to Week12/End of Treatment |
0.05; -0.08; -0.18; -0.24 | 0.2449 |
| SECONDARY Change in Total Cholesterol From Baseline to Week12/End of Treatment |
0.107; -0.144; 0.058; 0.081 | 0.2510 |
| SECONDARY Change in High Density Lipoprotein-Cholesterol (HDL-C) From Baseline to Week12/End of Treatment |
-0.007; -0.025; -0.085; 0.002 | 0.6951 |
| SECONDARY Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Week12/End of Treatment |
0.011; -0.094; 0.155; 0.092 | 0.5576 |
| SECONDARY Change in Triglycerides From Baseline to Week12/End of Treatment |
0.156; -0.006; 0.017; -0.045 | 0.5732 |
| SECONDARY Change in Fibrosis-4 (Fib-4) Score From Baseline to Week 12/End of Treatment |
-0.11; -0.07; -0.09; -0.15 | 0.5737 |
| SECONDARY Change in Body Weight From Baseline to Week 12/End of Treatment |
0.96; 0.92; 0.20; 0.08 | 0.9552 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03763877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.