Table 2. Ongoing Clinical Trials without published results for treatment of Nonalcoholic Steatohepatitis.
Drug | Mechanism of action | Estimated enrollment | Doses | Primary outcome | ClinicalTrials.gov identifier |
---|---|---|---|---|---|
NGM282 | Fibroblast growth factor 19 analogue | 250 | 5 experimental doses | Change in absolute liver fat content at week 24 | NCT02443116 |
CORT118335 | Glucocorticoid receptor modulator/mineralocorticoid receptor antagonist | 120 | 600 mg | Change in liver fat content at week 12 | NCT03823703 |
Betaine | Increases S-adenosylmethionine levels | 26 | 20 mg | Change in steatosis, necroinflammatory activity, and fibrosis at 1 year | NCT00586911 |
Tirzepatide | Gastric inhibitory polypeptide/glucagon-like peptide-1 agonist | 196 | 5 mg, 10 mg, 15 mg | Reversal of NASH with no worsening of fibrosis at week 52 | NCT04166773 |
Atorvastatin, L-carnitine | Atorvastatin: inhibits 3-hydroxy-3-methylglutaryl coenzyme A reductase; L-Carnitine: cofactor for β-oxidation | 440 | Atorvastatin: 20 mg, L-carnitine: 1,000 mg | Improvement in liver stiffness at year 2 | NCT01617772 |
EDP-305 | Farnesoid X receptor agonist | 134 | 2 experimental doses | Change in ALT levels at week 12 | NCT03421431 |
TERN-101 | Farnesoid X receptor agonist | 96 | 3 experimental doses | Incidence of adverse events | NCT04328077 |
Solithromycin | Macrolide antibiotic with anti-inflammatory and immunoregulatory properties | 10 | 200 mg | Change in NAS at week 13 | NCT02510599 |
LPCN 1144 | Androgen receptor agonist | 75 | 450 mg | Change in hepatic fat fraction at 12 weeks | NCT04134091 |
Aldafermin | Fibroblast growth factor 19 analogue | 152 | 3 experimental doses | Histologic response at week 24 | NCT03912532 |
GR-MD-02 | Galectin-3 inhibitor | 162 | 2 mg/kg, 8 mg/kg | Reduction in hepatic venous pressure gradient at 1 year | NCT02462967 |
ALT, alanine aminotransferase; NAS, nonalcoholic fatty liver disease activity score; NAS, nonalcoholic steatohepatitis.