Low-Dose Pioglitazone in Patients With NASH (AIM 2)
Recruiting · Gainesville, Florida
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
To determine the safety and efficacy of low-dose pioglitazone (15 mg per day) on liver histology in in patients with T2DM with biopsy-proven nonalcoholic steatohepatitis (NASH).
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
To determine the safety and efficacy of low-dose pioglitazone (15 mg per day) on liver histology in in patients with T2DM with biopsy-proven nonalcoholic steatohepatitis (NASH).
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults age 21 to 75 who can talk with the study doctor and sign informed consent.
- •People with type 2 diabetes (T2DM) based on medical history, medicines, or fasting glucose or HbA1c results.
- •People whose HbA1c is ≤ 9.5% if they are only using diet, or whose diabetes medicine dose has been stable for at least 2 months.
- •People able to stay on stable diabetes medicines during the study (except if blood sugar control gets worse).
- •People with certain blood test and liver health levels (including hemoglobin, white blood cells, platelets, albumin, creatinine, INR, bilirubin, AST/ALT not too high).
🚫 You may not be able to join if…
- •People who drink more than a certain amount of alcohol each day or have alcohol abuse that is judged to be present.
- •People who use long-term medicines that can worsen blood sugar tolerance unless they were on a stable dose for 4 weeks before the study.
- •People taking medicines that can cause fat buildup in the liver (for example some hormone medicines, amiodarone, methotrexate, tamoxifen/raloxifene, high-dose prednisone or similar, or chloroquine).
- •People who take vitamin E (800 IU/day or more) or who take pioglitazone or other FDA-approved NASH drugs during the study.
- •People with other liver diseases besides NASH, cirrhosis or liver “decompensation” (like ascites, bleeding esophagus varices, or spontaneous encephalopathy), or other fatty liver causes.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 21–75
- ✓Have Type 2 diabetes
- !Some conditions may not be a fit: Fatty liver disease (NASH/MASH), Heart / cardiovascular disease, High blood pressure
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
To determine the safety and efficacy of low-dose pioglitazone (15 mg per day) on liver histology in in patients with T2DM with biopsy-proven nonalcoholic steatohepatitis (NASH).
Is it safe? Who makes sure of that?+
This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. This study may also compensate you for your time and travel — the team will tell you the amount before you join. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT04501406 · Locations: Florida