A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
NCT ID: NCT03763877
Last Updated: 2021-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2019-03-29
2020-08-10
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
PXL770 Dose 1
PXL770
Oral capsule
Group 2
PXL770 Dose 2
PXL770
Oral capsule
Group 3
PXL770 Dose 3
PXL770
Oral capsule
Group 4
Placebo oral capsule
Placebo Oral Capsule
Oral capsule
Interventions
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PXL770
Oral capsule
Placebo Oral Capsule
Oral capsule
Eligibility Criteria
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Inclusion Criteria
* 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 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
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 02
Los Angeles, California, United States
Study Site 01
Gainesville, Florida, United States
Study Site 11
Ocoee, Florida, United States
Study Site 15
Orlando, Florida, United States
Study Site 10
Athens, Georgia, United States
Study Site 03
Indianapolis, Indiana, United States
Study Site 07
Marrero, Louisiana, United States
Study Site 05
West Monroe, Louisiana, United States
Study Site 08
Berlin, New Jersey, United States
Study Site 09
Durham, North Carolina, United States
Study Site 13
Rapid City, South Dakota, United States
Study Site 06
Arlington, Texas, United States
Study Site 04
San Antonio, Texas, United States
Study Site 12
San Antonio, Texas, United States
Study Site 14
Richmond, Virginia, United States
Countries
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References
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Cusi K, Alkhouri N, Harrison SA, Fouqueray P, Moller DE, Hallakou-Bozec S, Bolze S, Grouin JM, Jeannin Megnien S, Dubourg J, Ratziu V. Efficacy and safety of PXL770, a direct AMP kinase activator, for the treatment of non-alcoholic fatty liver disease (STAMP-NAFLD): a randomised, double-blind, placebo-controlled, phase 2a study. Lancet Gastroenterol Hepatol. 2021 Nov;6(11):889-902. doi: 10.1016/S2468-1253(21)00300-9. Epub 2021 Sep 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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PXL770-004
Identifier Type: -
Identifier Source: org_study_id