Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis

Launched by OASIS PHARMACEUTICALS, LLC · Jan 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called OA-235i to see if it is safe and well-tolerated in people who have a liver condition known as nonalcoholic steatohepatitis (NASH). NASH is a type of fatty liver disease that occurs in people who drink little to no alcohol and can lead to serious liver problems. The trial is currently looking for participants between the ages of 18 and 70 who have a body weight between 50 and 150 kg and a body mass index (BMI) of 25 to 40. To qualify, participants should have either a recent diagnosis of NASH confirmed by a liver biopsy or imaging tests, or meet certain health criteria indicating the presence of metabolic syndrome, which includes factors like obesity and high blood sugar.

Participants in this study will receive a single dose of the medication and will be monitored closely to assess its safety and how the body processes it. It’s important to note that individuals with advanced liver disease or other specific liver conditions are not eligible to participate. This trial is a first step in understanding how OA-235i works and could potentially lead to new treatment options for people affected by NASH in the future.

Gender

ALL

Eligibility criteria

• Main Inclusion Criteria:
• • 1. Male and female subjects between the ages of 18 and 70 years, inclusive, at Screening.
• 2. Suspected or confirmed diagnosis of noncirrhotic NAFLD/NASH without advanced hepatic fibrosis by one of the following:
• • 1. Histologically with liver biopsy within 2 years prior to Screening (documentation with pathology report); or
• • 2. Radiologically with ≥5% steatosis measured by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF), or controlled attenuation parameter (CAP) \>238 dB/m via FibroScan assessment, or presence of hepatic steatosis on abdominal ultrasound ; or
• • 3. Clinically with a diagnosis of Metabolic Syndrome (MetS) reflecting the presence of at least 3 of 5 factors/criteria (ie, abdominal obesity, elevated triglycerides, reduced HDL-C, elevated blood pressure, and/or elevated fasting glucose \[IFG or type 2 diabetes mellitus\]) as defined by the National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) \[Grundy 2005\]; and fatty liver on imaging within 1 year prior to Screening.
• Key Exclusion Criteria:
• • 1. History or presence of cirrhosis as assessed by Investigator following review of diagnostic measures (clinical, imaging, histopathology, or laboratory).
• • 2. Clinical evidence of hepatic decompensation (laboratory or clinical abnormalities- ascites, variceal bleeding, etc.).
• • 3. History or presence of other concomitant liver disease (eg, hepatitis B \& C, alcoholic liver disease, autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin (A1AT) deficiency, bile duct obstruction, liver primary or metastatic cancer, drug-induced liver disease.