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

Overview

About this study

The primary purpose of this study is to evaluate the safety and tolerability, local and systemic, of single ascending doses and multiple doses of OA-235i administered subcutaneously (sc) to adult subjects with suspected or confirmed diagnosis of noncirrhotic nonalcoholic steatohepatitis (NASH) with no fibrosis to moderate fibrosis (stages F0-F2).

Its secondary objectives are to characterize the systemic exposure (pharmacokinetics [PK]) of single ascending doses and multiple doses of sc OA-235i in plasma and urine in adult subjects with suspected or confirmed diagnosis of noncirrhotic NASH with no fibrosis to moderate fibrosis (stages F0-F2), and to document the pharmacodynamic (PD) effects of single ascending doses and multiple doses of sc OA-235i via leukocyte functional assays in adult subjects with suspected or confirmed diagnosis of noncirrhotic NASH with no fibrosis to moderate fibrosis (stages F0-F2) and correlate PD effects with the PK profile of OA-235i.
 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 with no fibrosis to moderate fibrosis (stages F0-F2) 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?) > 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
    • Clinically with a diagnosis of Metabolic Syndrome (MetS) reflecting the presence of at least 3 of 5 factors/criteria (i.e., 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.
  • Subjects who are willing and able to comply with all scheduled visits, clinical research unit (CRU) confinement, dosing plan, laboratory tests, and other study procedures and restrictions detailed in this protocol and listed in the informed consent form/document (ICF).
  • Evidence of a personally signed and dated ICF, approved by the IRB, indicating that the subject has been informed of all pertinent aspects of the study, understands, and voluntarily agrees to participate in the study, and authorizes the use of protected health information (PHI) in accordance with national and local subject privacy regulations (i.e., HIPAA) prior to the initiation of any study-specific procedure.

Exclusion Criteria:

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/15/24. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Manal Abdelmalek, M.D.

Closed for enrollment

More information

Publications

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Additional contact information

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