Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT03437720
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03437720
Study Brief:
Protocol Section:
NCT03437720