A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD

Poxel

Status and phase: Completed; Phase 1

Conditions: Nonalcoholic Fatty Liver

Treatments: Drug: PXL770; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03950882

PXL770-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups, including a placebo group

PXL770

Experimental group

Description:

PXL770 500 mg once daily (QD) for 4 weeks

Treatment:

Drug: PXL770

Drug: Placebo

Placebo

Placebo Comparator group

Description:

placebo once daily (QD) for 4 weeks

Treatment:

Drug: PXL770

Drug: Placebo