NAFLD HEROES: Semaglutide for Non-Alcoholic Fatty Liver Disease
This study, called NAFLD HEROES, is looking into non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), which is a more severe form of NAFLD. Researchers want to understand how the liver responds to food in people with NAFLD and how this relates to their response to the drug semaglutide. Semaglutide is given as an injection once a week. The study aims to see if semaglutide can improve liver health, specifically looking for changes in liver tissue (histological improvement) and overall health (clinical improvement) after 30 weeks. They will also examine changes in liver gene expression after a sugar drink. You may be able to join if you are 18 or older and have evidence of fatty liver disease from a biopsy or imaging. The study plans to enroll 104 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 104 participants. It is not specified if it is randomized or blinded.
- What's involved
- You will be screened with a medical history, physical exam, blood tests, and imaging. Within 2-8 weeks of enrollment, you will stay in the clinic for several days.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at 30 weeks, suggesting follow-up for at least that duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
At a glance
Conditions
NCT03884075
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
National Institutes of Health Clinical Center
Bethesda, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Yaron Rotman, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Histological Improvement30 weeks
\>= point decrease in NAFLD activity score (range 0-8, high scores indicate more activity)
- Clinical Improvement30 weeks
Reduction of liver fat content (measure with 1H-magnetic resonance spectroscopy) by \>= 25% and reduction of ALT by \>=25% or normalization of ALT
- Change in hepatic gene expression2 hours after an oral 75g glucose load
Change in hepatic gene expression for biopsies performed at baseline and 2 hours after an oral 75g glucose load