Qualifying a lab-grown liver model to help test drugs for fatty liver disease
MPS Qualification Section
This project uses lab-grown human liver models to predict how drugs behave and whether they are safe and effective for people with non-alcoholic fatty liver disease (NAFLD).
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Pittsburgh at Pittsburgh NIH-funded |
| Lab location | 1 site (Pittsburgh, United States) |
| Project ID | NIH-11294216 on NIH RePORTER |
What this research studies
From a patient point of view, researchers are developing and qualifying two small lab models of the human liver (one with blood vessels) made from human cells to act like a real diseased liver. They will test whether these models can predict how quickly drugs are cleared by the liver and whether drugs cause harm in livers affected by NAFLD, and whether the vascular model can forecast which patients might respond to a given drug. The team plans to work with an FDA consultant and the agency to formally qualify these models as official drug development tools for dosing and trial inclusion decisions. The effort aims to reduce animal testing and make early drug testing more directly relevant to people with fatty liver disease.
Who could benefit from this research
Good fit: People with non-alcoholic fatty liver disease (NAFLD), especially those being considered for participation in clinical trials, would be the most relevant candidates.
Not a fit: People without liver disease or those with liver conditions unrelated to NAFLD (for example viral or alcohol-related liver disease) may not directly benefit from this specific work.
Why it matters
Potential benefit: If successful, this could make NAFLD clinical trials safer and more effective by improving dosing decisions and selecting patients most likely to benefit.
How similar studies have performed: Organ-on-chip and microphysiological liver models have shown promising early results for predicting drug toxicity and clearance, but using them for NAFLD dosing and patient selection is still relatively new and under formal qualification.
Where this research is happening
Pittsburgh, United States
- University of Pittsburgh at Pittsburgh — Pittsburgh, United States (Active)
Researchers
- Principal investigator: Schurdak, Mark E — University of Pittsburgh at Pittsburgh
- Study coordinator: Schurdak, Mark E
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.