Plain-English translation of NCT04501406 on ClinicalTrials.gov โ ยท Source last updated ยท Translation generated ยท How we translate trials
Phase 2 โ Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing , a diabetes medication, at a lower dose than typically used to see if it can safely help people with both type 2 diabetes and nonalcoholic fatty liver disease (NASH). Researchers already know the medication works at higher doses, but they want to find out if a smaller daily dose of 15 mg might also be effective and perhaps have fewer side effects. You would receive either the medication or a placebo (inactive pill) for 72 weeks.
While this medication has proven helpful for fatty liver disease at standard doses in previous studies, doctors don't yet know if a lower dose could work just as well. Testing a lower dose matters because it might give patients the same health benefits while reducing the risk of unwanted side effects.
You likely qualify ifโฆ
You likely don't qualify ifโฆ
You would visit the University of Florida research center for a screening visit where doctors would perform blood tests, an EKG heart test, an ultrasound of your liver, and possibly an MRI scan to confirm you have fatty liver disease. If you qualify, you would be randomly assigned to take either the study medication or a placebo pill once daily for 72 weeks (about 18 months). Throughout the study, you would have regular follow-up visits to check your health, blood work, and how well the treatment is working.
AI-generated summary from trial data ยท Jun 3, 2026 ยท Not medical advice
United States
Phase
Testing effectiveness
Sponsor
University of Florida
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrollment target
~166 participants
Started
December 2020
Primary completion
August 2027
Age range
21 Years โ 75 Years
Last updated on clinicaltrials.gov in April 2025.
Reach out to the team running this trial. Response times vary โ some teams are faster than others.
Central contact
Kenneth Cusi, M.D.
University of Florida
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first โ no email needed to get started.