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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
3,239 Previous Clinical Trials
3,771,576 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
2,376 Previous Clinical Trials
4,315,744 Total Patients Enrolled
46 Trials studying Non-alcoholic Fatty Liver Disease
10,007 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
~10 spots leftby Jun 2025
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