Safety evaluation of OA-235i for nonalcoholic steatohepatitis

A Phase 1a/1b Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OA-235i, a PAR2 Inhibitor, in Adults With Nonalcoholic Steatohepatitis

This study is testing a new medication called OA-235i to see if it's safe for people with nonalcoholic steatohepatitis or fatty liver disease.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Oasis Pharmaceuticals, LLC (Industry-sponsored)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT05680233 on ClinicalTrials.gov

What this trial studies

This Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of OA-235i in individuals diagnosed with nonalcoholic steatohepatitis (NASH) or noncirrhotic nonalcoholic fatty liver disease (NAFLD). Participants will receive a single ascending dose of the medication, with up to five cohorts involved in the dose escalation. The study will also include a multiple dose expansion cohort for further evaluation. The goal is to determine the safety profile of OA-235i in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of noncirrhotic NAFLD/NASH and a BMI between 25 and 40.

Not a fit: Patients with advanced hepatic fibrosis or those outside the specified age and BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients suffering from nonalcoholic steatohepatitis.

How similar studies have performed: Other studies have shown promise in targeting nonalcoholic fatty liver disease, but this specific approach with OA-235i is novel.

Eligibility criteria

Main 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 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) \>288 dB/m via FibroScan assessment, or presence of hepatic steatosis on abdominal ultrasound 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 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.

Where this trial is running

Rochester, Minnesota

• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Study coordinator: Manal Abdelmalek, MD

Conditions Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver