Nonalcoholic SteatohepatitisPhase 1NCT05680233
Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis
A Phase 1 study testing OA-235i (4 mg), OA-235i (8 mg) and OA-235i (16 mg) in people with Nonalcoholic Steatohepatitis and Nonalcoholic Fatty Liver, run by Oasis Pharmaceuticals, LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver
- What is being tested?
- OA-235i (4 mg), OA-235i (8 mg) and OA-235i (16 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 2 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.).
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 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.
Read the detailed description
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.
- Being tested
- OA-235i (4 mg), OA-235i (8 mg), OA-235i (16 mg), OA-235i (30 mg), OA-235i (40 mg)
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OA-235i (4 mg)Drug
Also called PAR2 inhibitor
3 participants will receive 4 mg as a single subcutaneous dose
OA-235i (8 mg)Drug
Also called PAR2 inhibitor
3 participants will receive 8 mg as a single subcutaneous dose
OA-235i (16 mg)Drug
Also called PAR2 inhibitor
3 participants will receive 16 mg as a single subcutaneous dose
OA-235i (30 mg)Drug
Also called PAR2 inhibitor
3 participants will receive 30 mg as a single subcutaneous dose
OA-235i (40 mg)Drug
Also called PAR2 inhibitor
3 participants will receive 40 mg as a single subcutaneous dose
OA-235i or placeboDrug
Also called PAR2 inhibitor, placebo
9 participants will receive a daily subcutaneous dose of OA-235i or placebo for 7 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| OA-235i (4-40 mg) | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with treatment-emergent with adverse events (incidence and severity)
Measured: 30 Days
Secondary outcomes (4)
To characterize the OA-235i Pharmacokinetics (PK) by Cmax
OA-235i PK by peak plasma concentration (Cmax)
Measured: 8 Days
To characterize the OA-235i Pharmacokinetics (PK) by t1/2
OA-235i PK by the terminal elimination half-life (t1/2)
Measured: 8 Days
To characterize the OA-235i Pharmacokinetics (PK) by Tmax
OA-235i PK by time to peak plasma concentration (Tmax)
Measured: 8 Days
To characterize the OA-235i Pharmacokinetics (PK) by AUC
OA-235i PK by area under the plasma concentration versus time curve (AUC)
Measured: 8 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start6 Mar 2023
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Single ascending dose (SAD) sequential group study of a sc dose of OA-235i in five (5) planned dose cohorts with 3 subjects/cohort administering a bolus injection at escalating dose levels from 4 to 40 mg. 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oasis Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Athan Kuliopulos, MD, PhD, Study director, Oasis Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680233
- Sponsor's protocol ID
- OAS-235i-101
- Other IDs
- 5R44DK101240
- Status last verified
- Jun 2025
- First submitted
- 12 Dec 2022
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05680233
- Acronym / sponsor ID
- OAS-235i-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Oasis Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Mayo Clinic
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single ascending dose (SAD) sequential group study of a sc dose of OA-235i in five (5) planned dose cohorts with 3 subjects/cohort administering a bolus injection at escalating dose levels from 4 to 40 mg. 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.
| Arm | Type | Receives |
|---|---|---|
| OA-235i (4-40 mg) | Experimental | 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 placeboSingle 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OA-235i (4 mg)Also: PAR2 inhibitor3 participants will receive 4 mg as a single subcutaneous dose | Drug | OA-235i (4-40 mg) |
| OA-235i (8 mg)Also: PAR2 inhibitor3 participants will receive 8 mg as a single subcutaneous dose | Drug | OA-235i (4-40 mg) |
| OA-235i (16 mg)Also: PAR2 inhibitor3 participants will receive 16 mg as a single subcutaneous dose | Drug | OA-235i (4-40 mg) |
| OA-235i (30 mg)Also: PAR2 inhibitor3 participants will receive 30 mg as a single subcutaneous dose | Drug | OA-235i (4-40 mg) |
| OA-235i (40 mg)Also: PAR2 inhibitor3 participants will receive 40 mg as a single subcutaneous dose | Drug | OA-235i (4-40 mg) |
| OA-235i or placeboAlso: PAR2 inhibitor, placebo9 participants will receive a daily subcutaneous dose of OA-235i or placebo for 7 consecutive days | Drug | OA-235i (4-40 mg) |
Primary outcome
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 30 Days
Number of participants with treatment-emergent with adverse events (incidence and severity)
4 secondary outcomes
To characterize the OA-235i Pharmacokinetics (PK) by Cmax
Time frame: 8 Days
To characterize the OA-235i Pharmacokinetics (PK) by t1/2
Time frame: 8 Days
To characterize the OA-235i Pharmacokinetics (PK) by Tmax
Time frame: 8 Days
To characterize the OA-235i Pharmacokinetics (PK) by AUC
Time frame: 8 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
Related trials for Nonalcoholic Steatohepatitis
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athan Kuliopulos, MD, PhD study director
Oasis Pharmaceuticals, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OA-235i (4 mg), OA-235i (8 mg) and OA-235i (16 mg) in people with Nonalcoholic Steatohepatitis and Nonalcoholic Fatty Liver, run by Oasis Pharmaceuticals, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.