Status:
WITHDRAWN
Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease
Lead Sponsor:
Sanofi
Conditions:
Non-alcoholic Steatohepatitis
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 n...
Detailed Description
Study duration per participant will be approximately 64 weeks, consisting of up to 8 weeks screening plus 52 weeks treatment and 4 weeks post treatment follow-up.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03437720
Start Date
May 23 2019
End Date
August 25 2021
Last Update
April 13 2022
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