Table 3 Drugs in clinical trial for MASLD and MASH treatment
Drug classes based on MOA | Drugs | NCT | Target Population | Outcome/topline result | Reference |
|---|---|---|---|---|---|
Drugs in clinical trial/phase II | |||||
 PPAR agonists | Saroglitazar | NCT03061721 | MASLD/MASH | Improves insulin sensitivity; Reduction in liver fat content, cholesterol levels, and TGs | |
| Â | Lanifibranor | NCT030080708 | Non-cirrhotic MASH | Improves glucose and FFA metabolism; reduction in SAF-A score without worsening of fibrosis | |
| Â | Â | NCT03459079 | T2MD and NAFLD | Improves glucose and FFA metabolism | NP |
| Â | Pemafibrate | NCT03350165 | MASLD | Enhances FFA metabolism; Reduced liver stiffness, ALT, and LDL-C | |
 THR-β agonists | VK2809 | NCT02927184 | Primary hypercholesterolemia and MASLD | Reduces plasma and liver lipids; Improves liver fibrosis | NP |
 FGF21 analogues | Pegozafermin | NCT04048135 | MASH or MASLD | Improves insulin resistance; Reduction in serum lipids, body weight, liver fat, and measures of liver function | |
| Â | Pegozafermin | NCT04929483 | MASH | Improves insulin resistance; Reduces serum lipids and body weight; Improvements in fibrosis | |
 SCD1 inhibitors | Aramchol | NCT02279524 | MASH | MASH resolution without worsening fibrosis; Reduced levels of ALT, AST, and liver fat | |
 FASN inhibitors | TVB-2640 | NCT03938246 | MASH | Reduction in liver fat content | |
| Â | Â | NCT04906421 | MASH | Inhibits DNL; Improves fibrosis and inflammation | NP |
| Â | Denifanstat | MASH and F2 or F3 | Improvement in NAS, MASH resolution, and fibrosis | ||
 DGAT1/2 inhibitors | Pradigastat | NCT01811472 | MASLD | Reduced liver fat content and fasting TGs | NP |
 FXR agonists | Tropifexor | NCT02855164 | MASH | Reduced liver fat content and ALT levels | |
 GLP1R/GCGR/GIPR agonists | Tirzepatide | MASH | Resolution of MASH without worsening of fibrosis | ||
| Â | Survodutide | MASH | Decreased liver fat content and improved MASH without worsening fibrosis | ||
| Â | Retatrutide | MASH | Reduction in liver fat, improved insulin sensitivity and lipid metabolism, and MASH resolution | ||
 ACC inhibitors | GS-0976 | MASH | Suppressed DNL and reduced fibrosis-associated biomarkers | ||
| Â | Clesacostat | NCT03248882 | MASLD | Reduce liver fat | NP |
 A3AR agonist | Namodenoson | NCT04697810 | MASH | Reduces inflammation; Improves fibrosis | NP |
 AMPK activators | PXL770 | NCT03763877 | MASLD | Reduces liver fat and HbA1c | NP |
Drugs in clinical trial/Phase III | |||||
 PPAR agonists | Lanifibranor | NCT04849728 | MASH and F2/3 | Improves glucose and FFA metabolism | NP |
 THR-β agonists | Resmetriom | NCT03900429 | MASH and F1B, F2, or F3 | MASH resolution and improvement in liver fibrosis by at least one stage | |
 SCD1 inhibitors | Aramchol | NCT04104321 | MASH and comorbidity | Reduces DNL; Enhances fatty acid oxidation | NP |
 GLP1R/GCGR/GIPR agonists | Semaglutide | NCT04822181 | Non-cirrhotic MASH | Increase insulin secretion and sensitivity; Inhibits hepatic gluconeogenesis Resolution of MASH without worsening of fibrosis | NP |
 SGLT2 inhibitors | Dapagliflozin | NCT03723252 | MASH | Reduces steatosis and fibrosis markers (ALT and GTT) | NP |
Drugs in Clinical trial/Phase IV | |||||
 PPAR agonists | Saroglitazar | NCT05872269 | MASLD with Obesity, T2DM, Dyslipidemias, Metabolic syndrome | Improves insulin sensitivity | NP |
