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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03950882

Enrollment

Registered

2019-05-15

Start date

2019-08-01

Completion date

2020-03-31

Last updated

2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic Fatty Liver

Brief summary

This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.

Detailed description

The study will be performed in subjects with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of PXL770 exposure in plasma.

Interventions

DRUGPXL770

Oral capsule

DRUGPlacebo

Oral capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
PK parameters of PXL770	Day 26	AUC : Area under the plasma concentration curve

Secondary

Measure	Time frame	Description
Plasma PK parameters of PXL770	Day 26	Minimum plasma concentration (Cmin)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026