← Back to Search

Other

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
No Placebo-Only Group

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,326 Previous Clinical Trials
3,059,459 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
2,439 Previous Clinical Trials
4,324,801 Total Patients Enrolled
56 Trials studying Non-alcoholic Fatty Liver Disease
10,149 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
~8 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top