A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD
A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
1 other identifier
interventional
17
1 country
1
Brief Summary
This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2019
CompletedFirst Posted
Study publicly available on registry
May 15, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedJune 11, 2021
June 1, 2021
8 months
May 13, 2019
June 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
PK parameters of PXL770
AUC : Area under the plasma concentration curve
Day 26
Secondary Outcomes (13)
Plasma PK parameters of PXL770
Day 26
Plasma PK parameters of PXL770
Day 26
Plasma PK parameters of PXL770
Day 26
Plasma PK parameters of PXL770
Day 26
Plasma PK parameters of PXL770
Day 26
- +8 more secondary outcomes
Study Arms (2)
PXL770
EXPERIMENTALPXL770 500 mg once daily (QD) for 4 weeks
Placebo
PLACEBO COMPARATORplacebo once daily (QD) for 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Subjects have given written informed consent
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Poxel SAlead
Study Sites (1)
High Point Clinical Trials Center
High Point, North Carolina, 27265, United States
Related Publications (1)
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.
PMID: 35028615DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2019
First Posted
May 15, 2019
Study Start
August 1, 2019
Primary Completion
March 29, 2020
Study Completion
March 31, 2020
Last Updated
June 11, 2021
Record last verified: 2021-06