Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
NCT ID: NCT04321343
Last Updated: 2023-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
117 participants
INTERVENTIONAL
2020-09-01
2022-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
PXL065 Dose 1
PXL065
PXL065 oral tablet
Group 2
PXL065 Dose 2
PXL065
PXL065 oral tablet
Group 3
PXL065 Dose 3
PXL065
PXL065 oral tablet
Group 4
Placebo oral tablet
Placebo oral tablet
Placebo oral tablet
Interventions
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PXL065
PXL065 oral tablet
Placebo oral tablet
Placebo oral tablet
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) ≤ 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) ≥ 45 mL/min/1.73m²
* Liver fat content ≥ 8% on MRI-PDFF
* Qualifying liver biopsy (NAS) ≥ 4 and fibrosis score F1, F2 or F3
* Effective contraception for women of child bearing potential
Exclusion Criteria
* Evidence of liver cirrhosis
* Evidence of hepatic impairment
* Positive serologic evidence of current infectious liver disease
* History of excessive alcohol intake
* Acute cardiovascular disease within 6 months prior to Randomization
* 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
18 Years
75 Years
ALL
No
Sponsors
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Poxel SA
INDUSTRY
Responsible Party
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Locations
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Study site 11
Chandler, Arizona, United States
Study site 12
Glendale, Arizona, United States
Study site 13
Tucson, Arizona, United States
Study site 21
Tucson, Arizona, United States
Study site 17
Chula Vista, California, United States
Study site 16
Fresno, California, United States
Study site 04
Huntington Park, California, United States
Study site 05
Los Angeles, California, United States
Study site 22
Orange, California, United States
Study site 06
Panorama City, California, United States
Study site 07
Santa Ana, California, United States
Study site 15
Boca Raton, Florida, United States
Study site 31
Fort Myers, Florida, United States
Study site 08
Port Orange, Florida, United States
Study site 01
Sarasota, Florida, United States
Study site 28
West Des Moines, Iowa, United States
Study site 18
Kansas City, Kansas, United States
Study site 24
Flowood, Mississippi, United States
Study site 10
Jackson, Mississippi, United States
Study site 27
East Syracuse, New York, United States
Study site 14
Fayetteville, North Carolina, United States
Study site 29
Summerville, South Carolina, United States
Study site 25
Chattanooga, Tennessee, United States
Study site 30
Clarksville, Tennessee, United States
Study Site 02
Germantown, Tennessee, United States
Study site 19
Austin, Texas, United States
Study site 09
Edinburg, Texas, United States
Study site 23
Edinburg, Texas, United States
Pinnacle Clinical Research (Study site 20)
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PXL065-003
Identifier Type: -
Identifier Source: org_study_id
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