A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD
NCT ID: NCT03950882
Last Updated: 2021-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2019-08-01
2020-03-31
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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PXL770
PXL770 500 mg once daily (QD) for 4 weeks
PXL770
Oral capsule
Placebo
Oral capsule
Placebo
placebo once daily (QD) for 4 weeks
PXL770
Oral capsule
Placebo
Oral capsule
Interventions
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PXL770
Oral capsule
Placebo
Oral capsule
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI): ≥ 25 kg/m²
* Hepatic steatosis (CAP ≥ 300)
* Insulin-resistant but not diabetic subjects
* Fasting plasma glucose \<126 mg/dL
* Glomerular filtration rate (eGFR) ≥ 60 mL/\[min\*1.73 m²\]
* Alanine amino transferase (ALT) \> 20 IU/L in females and \> 30 IU/L in males
* Effective contraception
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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High Point Clinical Trials Center
High Point, North Carolina, United States
Countries
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References
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Fouqueray P, Bolze S, Dubourg J, Hallakou-Bozec S, Theurey P, Grouin JM, Chevalier C, Gluais-Dagorn P, Moller DE, Cusi K. Pharmacodynamic effects of direct AMP kinase activation in humans with insulin resistance and non-alcoholic fatty liver disease: A phase 1b study. Cell Rep Med. 2021 Dec 21;2(12):100474. doi: 10.1016/j.xcrm.2021.100474. eCollection 2021 Dec 21.
Other Identifiers
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PXL770-003
Identifier Type: -
Identifier Source: org_study_id
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