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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
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 moreAwards & 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
3,353 Previous Clinical Trials
3,061,000 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
2,455 Previous Clinical Trials
4,335,085 Total Patients Enrolled
57 Trials studying Non-alcoholic Fatty Liver Disease
10,199 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Athan Kuliopulos, MD, PhDStudy DirectorOasis Pharmaceuticals, LLC
2 Previous Clinical Trials
132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have signs of liver failure, such as fluid in the abdomen or bleeding varices.I do not have any other liver diseases or conditions.I am between 18 and 70 years old.My BMI is between 25 and 40, and my weight is between 50-150 kg.I have been diagnosed with cirrhosis by a doctor.I have a non-cirrhotic fatty liver disease not due to heavy alcohol use, confirmed by tests or symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: OA-235i (4-40 mg)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.