Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)

Poxel

Status and phase: Completed; Phase 2

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Drug: PXL065; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04321343

PXL065-003

Details and patient eligibility

About

This study will assess the effect of 3 doses of PXL065 versus placebo on liver fat content in NASH patients after 36 weeks of treatment

Full description

The study will be performed in patients with NASH. The primary endpoint will be the assessment of the change in the percentage of liver fat content (assessed by MRI-PDFF).

Enrollment: 117 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients have given written informed consent
• Body mass index (BMI) ≤ 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) ≥ 45 mL/min/1.73m²
• Liver fat content ≥ 8% on MRI-PDFF
• Qualifying liver biopsy (NAS) ≥ 4 and fibrosis score F1, F2 or F3
• Effective contraception for women of child bearing potential

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 within 6 months prior to Randomization
• 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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117 participants in 4 patient groups, including a placebo group

Group 1

Experimental group

Description:

PXL065 Dose 1

Treatment:

Drug: PXL065

Group 2

Experimental group

Description:

PXL065 Dose 2

Treatment:

Drug: PXL065

Group 3

Experimental group

Description:

PXL065 Dose 3

Treatment:

Drug: PXL065

Group 4

Placebo Comparator group

Description:

Placebo oral tablet

Treatment:

Drug: Placebo oral tablet