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OA-235i for Non-alcoholic Fatty Liver Disease

Phase 1
Recruiting
Research Sponsored by Oasis Pharmaceuticals, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

This trial tests a new drug to see if it's safe & effective to treat fatty liver disease.

Who is the study for?
Adults aged 18-70 with non-cirrhotic Nonalcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH), stages F0-F2, and a BMI of ≥25 and <40 kg/m2. Participants must have evidence of fatty liver through biopsy, MRI, FibroScan®, or ultrasound, elevated ALT levels, or meet Metabolic Syndrome criteria. Excludes those with other liver diseases or cirrhosis.Check my eligibility
What is being tested?
The trial is testing multiple doses of OA-235i in patients with NASH to assess safety and how the body reacts to it. It's a Phase 1 study where participants receive increasing doses of OA-235i to find out what amount is safe.See study design
What are the potential side effects?
Since this is a first-in-human study for OA-235i, specific side effects are not yet known but will be closely monitored for any signs of organ inflammation, allergic reactions, digestive issues or changes in blood tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
To characterize the OA-235i Pharmacokinetics (PK) by AUC
To characterize the OA-235i Pharmacokinetics (PK) by Cmax
To characterize the OA-235i Pharmacokinetics (PK) by Tmax
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: OA-235i (4-40 mg)Experimental Treatment6 Interventions
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) 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.

Find a Location

Who is running the clinical trial?

Mayo ClinicOTHER
3,205 Previous Clinical Trials
3,766,761 Total Patients Enrolled
8 Trials studying Non-alcoholic Fatty Liver Disease
1,126 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Oasis Pharmaceuticals, LLCLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,315,043 Total Patients Enrolled
46 Trials studying Non-alcoholic Fatty Liver Disease
9,949 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

OA-235i (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05680233 — Phase 1
Non-alcoholic Fatty Liver Disease Research Study Groups: OA-235i (4-40 mg)
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: OA-235i Highlights & Side Effects. Trial Name: NCT05680233 — Phase 1
OA-235i (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05680233 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial cater to adults more than two decades old?

"The study's inclusion criteria state that only individuals aged 18 to 70 are eligible. There are 20 trials open for people under the age of majority, as well as 187 studies available for patients over 65 years old."

Answered by AI

Has the FDA provided authorization for OA-235i (4-30 mg)?

"Given the restricted amount of data regarding its efficacy and safety, our team at Power rated OA-235i (4-30 mg) a 1 on a scale from 1 to 3."

Answered by AI

Are current volunteers being accepted for this trial?

"Affirmative. Clinicaltrials.gov indicates that this trial is still recruiting participants, which it began doing on the 5th of January 2023 and last edited its information on the 3rd of January 2023. The study seeks 23 patients from one site in particular."

Answered by AI

What is the maximum limit of participants in this research endeavor?

"Affirmative. The clinicaltrials.gov website provides evidence that this experiment is currently open for recruitment, with an initial posting date of January 5th 2023 and the latest update being on March 1st 2023. 23 people are required to participate in trials at a singular research centre."

Answered by AI

Under what criteria are individuals qualified to participate in this research?

"This medical trial is admitting 23 individuals aged 18 - 70 with non-alcoholic fatty liver disease and meeting the following criteria: Male or female, BMI 25-40 kg/m2 (total body weight 50-150kg), evidence of hepatic steatosis on imaging within 1 year prior to screening, elevated serum ALT levels >30 U/L; diagnosis of Metabolic Syndrome reflecting presence of at least 3 out 5 components from NCEP ATP III (abdominal obesity, triglycerides elevation, low HDL-C concentrations, high blood pressure & IFG); seronegative hepatitis b and C."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How often would I need to travel to location of trial?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis
2023. "Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05680233.
All > Nonalcoholic Steatohepatitis
~10 spots leftby Apr 2025
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