Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sagimet Biosciences Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Aged ≥ 18 years with a body mass index (BMI) ≤40 kg/m2.
2. Prior liver biopsy within 24 months of randomization with fibrosis Stage 1 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
* Steatosis
* Ballooning degeneration
* Lobular inflammation
AND
Confirmation of ≥ 8% liver fat content on MRI-PDFF.
OR, if prior biopsy is not available:
Either overweight or obese or diabetic or ALT ≥ 30 U/L or fatty liver on ultrasound and at least one more feature of metabolic syndrome by Adult Treatment Panel III (ATP III) criteria.
AND
Magnetic resonance elastography (MRE) ≥ 2.5 kPa and MRI-PDFF ≥ 8% during screening.
You may not be if
1. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.
Note: Significant alcohol consumption is defined as average of \> 20 g/day in female subjects and \> 30 g/day in male subjects.
2. Type 1 diabetes.
3. Uncontrolled Type 2 diabetes defined as:
* HbA1c ≥ 9.5% during screening. (Subjects with HbA1c ≥ 9.5% may be rescreened).
* Basal insulin dose adjustment \> 10% within 60 days prior to enrollment.
* Requirement for glucagon-like peptide analogue or a complex oral anti-diabetic (OAD) regimen (3 or more OADs) within 6 months of screening.
* History of severe hypoglycemia (symptomatic hypoglycemia requiring outside assistance to regain normal neurologic status) within the previous year.
Note: Individual diabetes regimens will be reviewed by Investigator and may be adjusted based on American Diabetes Association guidelines.
4. Presence of cirrhosis on liver biopsy (Stage 4 fibrosis) or imaging.
