NCT05680233CompletedPhase 1
Safety Study of OA-235i in Subjects With 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
Source: ClinicalTrials.gov · Last updated 25 Jun 2025
Brief summary (registry, in English)
This study is a Phase 1, first-in-human single-dose escalation and multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OA-235i in subjects with nonalcoholic steatohepatitis.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 12 Dec 2022
- Start date
- 6 Mar 2023
- Primary completion date
- 2 Jul 2024
- Lead sponsor
- Oasis Pharmaceuticals, LLC
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05680233
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 24
- From 6 Mar 2023 to the primary completion date, 2 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Lab values
- History or presence of cirrhosis as assessed by Investigator following review of diagnostic measures (clinical, imaging, histopathology, or laboratory).
- Clinical evidence of hepatic decompensation (laboratory or clinical abnormalities- ascites, variceal bleeding, etc.).
Criteria the registry did not label
- Main Inclusion Criteria:
- Male and female subjects between the ages of 18 and 70 years, inclusive, at Screening.
- Suspected or confirmed diagnosis of noncirrhotic NAFLD/NASH without advanced hepatic fibrosis by one of the following:
- Histologically with liver biopsy within 2 years prior to Screening (documentation with pathology report); or
- 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
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.