A Phase 1 interventional study of OA-235i (4 mg) and OA-235i (8 mg) in Nonalcoholic Steatohepatitis and Nonalcoholic Fatty Liver, sponsored by Oasis Pharmaceuticals, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Oasis Pharmaceuticals, LLC · Phase 1, Interventional, and Treatment
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.
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single ascending dose (SAD) in participants with suspected or confirmed diagnosis of noncirrhotic nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) without advanced hepatic fibrosis. This dose-escalating strategy will test the safety of OA-235i when given as a single subcutaneous dosage using up to five successive cohorts. Each cohort will have three non-randomized participants receiving the active medication. One (1) planned multiple dose (MD) randomized, placebo-controlled expansion cohort with 9 NAFLD/NASH subjects will be enrolled for a 7-day dosing regimen at a dose level to be determined from the SAD portion of the study.
1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →This is the only study on the registry with Oasis Pharmaceuticals, LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Suspected or confirmed diagnosis of noncirrhotic NAFLD/NASH without advanced hepatic fibrosis by one of the following:
Key Exclusion Criteria:
Single ascending dose (SAD): OA-235i (4-40 mg) administered subcutaneously (SC) once to adult subjects with suspected or confirmed diagnosis of noncirrhotic nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) without advanced hepatic fibrosis. Multiple dose (MD): OA-235i (dose level to be determined from SAD) or placebo administered subcutaneously (SC) once daily for 7 days to adult subjects with suspected or confirmed diagnosis of noncirrhotic nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) without advanced hepatic fibrosis.
Drug: OA-235i (4 mg) · Drug: OA-235i (8 mg) · Drug: OA-235i (16 mg) · Drug: OA-235i (30 mg) · Drug: OA-235i (40 mg) · Drug: OA-235i or placebo
3 participants will receive 4 mg as a single subcutaneous dose
Also known as: PAR2 inhibitor
3 participants will receive 8 mg as a single subcutaneous dose
Also known as: PAR2 inhibitor
3 participants will receive 16 mg as a single subcutaneous dose
Also known as: PAR2 inhibitor
3 participants will receive 30 mg as a single subcutaneous dose
Also known as: PAR2 inhibitor
3 participants will receive 40 mg as a single subcutaneous dose
Also known as: PAR2 inhibitor
9 participants will receive a daily subcutaneous dose of OA-235i or placebo for 7 consecutive days
Also known as: PAR2 inhibitor, placebo
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with treatment-emergent with adverse events (incidence and severity)
Time frame: 30 Days
To characterize the OA-235i Pharmacokinetics (PK) by Cmax
OA-235i PK by peak plasma concentration (Cmax)
Time frame: 8 Days
To characterize the OA-235i Pharmacokinetics (PK) by t1/2
OA-235i PK by the terminal elimination half-life (t1/2)
Time frame: 8 Days
To characterize the OA-235i Pharmacokinetics (PK) by Tmax
OA-235i PK by time to peak plasma concentration (Tmax)
Time frame: 8 Days
To characterize the OA-235i Pharmacokinetics (PK) by AUC
OA-235i PK by area under the plasma concentration versus time curve (AUC)
Time frame: 8 Days
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease→