Overview

Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease

Status:
Withdrawn
Trial end date:
2021-08-25
Target enrollment:
0
Participant gender:
All
Summary
Primary Objective: - To evaluate the dose response relationship of SAR425899 compared to placebo on resolution of non-alcoholic steatohepatitis (NASH) with no worsening of fibrosis in diabetic and non-diabetic patients with histopathologically-confirmed NASH. Secondary Objectives: - To assess the effect of SAR425899 on overall non-alcoholic fatty liver disease (NAFLD) activity score (NAS), individual components of NAS (steatosis, hepatocyte ballooning, and lobular inflammation), and fibrosis score. - To assess to the effect of SAR425899 on MRI-PDFF (Magnetic Resonance Imaging-determined Proton Density Fat Fraction) derived parameters (total liver fat, liver volume, and fractional liver fat content). - To assess the effect of SAR425889 on body weight and waist/hip circumference ratio. - To assess SAR425899 pharmacokinetics. - To assess safety and tolerability of SAR425899.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Criteria
Inclusion criteria :

- Non-diabetic or type 2 diabetes mellitus with confirmed non-alcoholic steatohepatitis.

- Non-alcoholic fatty liver disease (NAFLD) activity score (NAS) >=4 with each of its
components >=1.

- Patients without Type 2 diabetes determined by HbA1c (glycated hemoglobin) <6.5% and
Fasting Plasma Glucose (FPG) <7.0 mmol/L (<126 mg/dL).

- Stable glycemic control (HbA1c <9.0%) and metabolic disorders managed with
diet/exercise and/or stable dose metformin and/or sulphonylureas for at least 3 months
prior to screening (type 2 diabetes patients).

- Signed written informed consent form.

Exclusion criteria:

- Diagnosis of type 1 diabetes mellitus.

- Previous insulin use or use of insulin within the last 6 months, except for episode(s)
of short-term treatment (<15 consecutive days) due to intercurrent illness.

- Body Mass Index (BMI) <25 kg/m2 or >45.0 kg/m2.

- Current participation in organized diet/weight reduction program or clinical trial of
weight control (within the last 3 months prior to screening), or weight loss attempt,
plans for major changes in physical activities or significant change in body weight in
the 2 months prior to screening (significant change in body weight is defined as >=5%
self-reported change within 6 months prior to randomization if a pre-existing liver
biopsy sample was collected prior to screening period.

- Current treatment with glucose-lowering agent(s) other than metformin or
sulphonylureas, weight loss drugs including orlistat, systemic steroids, methotrexate,
amiodarone, or Vitamin E.

- Alcoholism (past or present) and/or average alcohol consumption per week >21 units
(210 g) for males, >14 units (140 g) for females within the last 5 years.

- Poorly controlled hypertension (resting systolic blood pressure (SBP) >160 mm Hg
and/or resting diastolic blood pressure (DBP) >95 mm Hg) at screening.

- Some liver diseases, pancreatic disease, liver transplantation and types of cancer.

- Pregnant or breast-feeding women.

- Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of
birth control and/or who are unwilling or unable to be tested for pregnancy.

- Male subjects, whose partners are able to become pregnant, who do not accept to use a
condom during sexual intercourse from study inclusion up to 3 months after last
dosing; or who are planning to donate sperm from study inclusion up to 3 months after
last dosing.

- Patients with coronary, carotid, or peripheral artery revascularization procedures
planned during the screening or treatment phases of the protocol.

- Patients with unstable heart conditions.

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.