A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD

Poxel

Status and phase: Completed; Phase 2

Conditions: Nonalcoholic Fatty Liver

Treatments: Drug: PXL770; Drug: Placebo Oral Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03763877

PXL770-004

Details and patient eligibility

About

This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.

Full description

The study will be performed in patients with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of the change in the percentage of liver fat mass (assessed by MRI-PDFF).

Enrollment: 121 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) ≥ 25 to ≤ 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) ≥ 60 mL/[min*1.73m²]
• Alanine amino transferase (ALT) > 20 IU/L in females and > 30 IU/L in males
• Hepatic steatosis (MRI-PDFF ≥ 10%)
• 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 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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121 participants in 4 patient groups, including a placebo group

Group 1

Experimental group

Description:

PXL770 Dose 1

Treatment:

Drug: PXL770

Group 2

Experimental group

Description:

PXL770 Dose 2

Treatment:

Drug: PXL770

Group 3

Experimental group

Description:

PXL770 Dose 3

Treatment:

Drug: PXL770

Group 4

Placebo Comparator group

Description:

Placebo oral capsule

Treatment:

Drug: Placebo Oral Capsule