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

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a Phase 1, first-in-human single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OA-235i in subjects with nonalcoholic steatohepatitis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oasis Pharmaceuticals, LLC
• Collaborators: Mayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Criteria

Inclusion Criteria:

1. Male and female subjects between the ages of 18 and 70 years, inclusive, at Screening.

2. Body mass index (BMI) of ≥25 and <40 kg/m2 with a total body weight 50-150 kg (inclusive) at Screening and Day 1 Pre-dose.

3. Suspected or confirmed diagnosis of noncirrhotic NAFLD/NASH with no fibrosis to moderate fibrosis (stages F0-F2) 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™) >288 dB/m via FibroScan® assessment or presence of hepatic steatosis on abdominal ultrasound; and an increased serum alanine aminotransferase (ALT) >30 U/L within 1 year prior to Screening; 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 seronegative hepatitis B and C; and fatty liver on imaging within 1 year prior to Screening.

Exclusion Criteria:

1. History or presence of cirrhosis by any diagnostic measure (clinical, imaging, histopathology, or laboratory).

2. Evidence of decompensated liver disease (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.