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Fatty Acid Derivative
Group 1 for Non-alcoholic Fatty Liver Disease
Phase 2
Waitlist Available
Research Sponsored by Poxel SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body mass index (BMI) ≤ 50 kg/m²
Patients have given written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 36
Awards & highlights
Study Summary
This trial will compare the effectiveness of PXL065, a new potential treatment for NASH, against a placebo in reducing liver fat content over 36 weeks.
Eligible Conditions
- Non-alcoholic Fatty Liver Disease
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relative Change From Baseline to Week 36 in the Percentage of LFC (Assessed by MRI-PDFF) (Wilcoxon Test Sensitivity Analysis)
Relative Change From Baseline to Week 36 in the Percentage of Liver Fat Content (LFC) (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF])
Secondary outcome measures
Absolute Change From Baseline to Week 36 in the Percentage of LFC (Assessed by MRI-PDFF)
Change From Baseline to Week 36 in Adipo-IR
Change From Baseline to Week 36 in Adiponectin
+22 moreSide effects data
From 2022 Phase 2 trial • 117 Patients • NCT0432134316%
Fatigue
16%
Headache
16%
Arthralgia
12%
Urinary tract infection
12%
Diarrhoea
12%
Pain in extremity
12%
Vomiting
12%
Oedema peripheral
12%
Insomnia
8%
Dizziness
8%
Tooth infection
8%
Pain in jaw
8%
Abdominal pain
8%
Musculoskeletal pain
4%
Biliary dyskinesia
4%
Procedural pain
4%
Sinusitis
4%
Upper respiratory tract infection
4%
Pruritus
4%
Herpes zoster
4%
Osteoarthritis
4%
Nausea
4%
Myalgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
PXL065 7.5 mg QD
PXL065 15 mg QD
PXL065 22.5 mg QD
Placebo
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 3Experimental Treatment1 Intervention
PXL065 Dose 3
Group II: Group 2Experimental Treatment1 Intervention
PXL065 Dose 2
Group III: Group 1Experimental Treatment1 Intervention
PXL065 Dose 1
Group IV: Group 4Placebo Group1 Intervention
Placebo oral tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PXL065
2020
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Poxel SALead Sponsor
13 Previous Clinical Trials
722 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
154 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What portion of applicants met pre-screening criteria?
Met criteria
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