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. 2023 Jan 29;15(3):687. doi: 10.3390/nu15030687

Table 4.

Current late phase pharmaceutical trials in NAFLD (retrieved from ClinicalTrials.gov, accessed on 11 January 2023).

Trial Name Trial Therapies Recruiting ClinicalTrials.gov ID
An Investigator Initiated Prospective, Four Arms Randomized Comparative Study of Efficacy and Safety of Saroglitazar, Vitamin E and Life Style Modification in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH)

  • Saroglitazar (dual PPAR α/γ agonist)

  • Vitamin E

  • Lifestyle modification

 Yes NCT04193982
Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease

  • Lanifibranor (pan-PPAR agonist)

  • Placebo

 Yes NCT03459079
A Phase 3 Study to Evaluate the Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease (NAFLD) Patients (MAESTRO-NAFLD1)

  • Resmetirom (thyroid hormone receptor β-selective agonist)

 No NCT04197479
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)

  • Resmetirom (thyroid hormone receptor β-selective agonist)

 Yes NCT04951219
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)

  • Obeticholic acid (FXR agonist)

  • Placebo

 No NCT02548351
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (REVERSE)

  • Obeticholic acid (FXR agonist)

  • Placebo

 No NCT03439254
Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients With Non-alcoholic Steatohepatitis

  • Obeticholic acid (FXR agonist)

  • Vitamin E

 No NCT05573204
Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH) (ESSENCE)

  • Semaglutide (GLP-1RA)

  • Placebo

 Yes NCT04822181
Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)

  • Semaglutide (GLP-1RA)

 Yes NCT04216589
Researching an Effect of GLP-1 Agonist on Liver STeatosis (REALIST) (REALIST)

  • Dulaglutide (GLP-1RA)

 No NCT03648554
A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH) (SYNERGY-NASH)

  • Tirzepatide (dual GLP-1RA/GIP RA)

  • Placebo

 Yes NCT04166773
Dapagliflozin Efficacy and Action in NASH (DEAN)

  • Dapagliflozin (SGLT-2 inhibitor)

  • Placebo

 Yes NCT03723252
Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)

  • Dapagliflozin (SGLT-2 inhibitor)

 Yes NCT05459701
A Single Center, Randomized, Open Label, Parallel Group, Phase 3 Study to Evaluate the Efficacy of Dapagliflozin in Subjects With Nonalcoholic Fatty Liver Disease

  • Dapagliflozin (SGLT-2 inhibitor)

  • Placebo

 Yes NCT05308160
Effect of Empagliflozin on Liver Fat in Non-diabetic Patients

  • Empagliflozin (SGLT-2 inhibitor)

  • Placebo

 No NCT04642261
Efficacy and Safety of Dapagliflozin in Patients With Non-alcoholic Steatohepatitis

  • Pioglitazone (PPAR-γ agonist)

  • Dapagliflozin (SGLT-2 inhibitor)

 Yes NCT05254626
Canagliflozin on Liver Inflammation Damage in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver Disease

  • Pioglitazone (PPAR-γ agonist)

  • Canagliflozin (SGLT-2 inhibitor)

 No NCT05422092
Effect of Oral Anti-diabetic Medication on Liver Fat in Subjects With Type II Diabetes and Non-alcoholic Fatty Liver

  • Pioglitazone (PPAR-γ agonist)

  • Empagliflozin (SGLT-2 inhibitor)

 Yes NCT04976283
Low-Dose Pioglitazone in Patients With NASH (AIM 2)

  • Pioglitazone (PPAR-γ agonist)

 Yes NCT04501406