Table 2.
Ongoing and completed (not yet published) clinical trials to address the proposed effects of SGLT2i(s) on NAFLD
| (A) Ongoing Trials | |||||||
|---|---|---|---|---|---|---|---|
| Questions under study | SGLT2i used | Population and (n) | Trial design | Treatment duration | Comparison | Histology | Primary outcome |
| Comparison of the effects of thiazolidinediones, SGLT2i alone, and combination therapy on NAFLD in T2DM patients with fatty liver | Empagliflozin | South Korea (n=60) | Prospective, open label, randomized, single-institution | 6 months | Pioglitazone, combination of pioglitazone and Empagliflozin | No | Liver fat change measured by MRI-PDFF |
| Effect of SGLT2i versus sulfonylurea in patients with T2DM and NAFLD | Tofogliflozin | Japan (n=40) | Open label, randomized | 11.2 months | Glimepiride | Yes | Histologic features of NAFLD |
| Effect of empagliflozin on NAFLD in Asian patients with T2DM | Empagliflozin | Malaysia (n=25) | Prospective open-label | 6 months | None | Yes | Histologic grade and serum FGF-21 |
| Efficacy of dapagliflozin and its action in NASH | Dapagliflozin | China (n=100) | Multicenter, randomized, placebo-controlled | 12 months | Placebo | Yes | Score of liver histology |
| Hepatic metabolic flexibility in obese patients with NAFLD and NASH | Not specified | Denmark (n=16) | Prospective cohort | 48 months | GLP-1RA or combination of GLP-1RA and SGLT2i | No | Systemic and splanchnic FFA and VLDL-TG balance |
| SGLT2i(s) as a novel treatment for pediatric NAFLD | Empagliflozin | United States, (n=40) | Double blind placebo controlled | 6 months | Placebo | No | Change in hepatic fat fraction |
| (B) Completed (not yet published) Trials | |||||||
| Questions under study | SGLT2i used | Population and (n) | Trial design | Treatment duration | Comparison | Histology | Primary Outcome |
| SGLT2 inhibitors and metformin on metabolism and NASH | Dapagliflozin | United Kingdom (n=20) | Non-Randomized, open Label | 3 months | Metformin | No | Magnetic resonance imaging/spectroscopy |
| Effects of ipragliflozin on NAFLD in T2DM patients treated with metformin and pioglitazone | Ipragliflozin | Korea (n=44) | Randomized, open Label | 6 months | Metformin and Pioglitazone versus added Ipragliflozin | No | Changes in visceral fat area measured by DEXA |
| Effects of empagliflozin on liver fat, energy metabolism, and body composition in patients with type 2 diabetes (EmLiFa) | Empagliflozin | Germany (n=84) | Randomized, parallel assignment | 6 months | Placebo | No | Liver fat content measured with magnetic resonance spectroscopy |
Notes: Data from https://clinicaltrials.gov (2019).75
Abbreviations: MRI-PDFF, Magnetic Resonance Imaging-Derived Proton Density Fat Fraction; FGF-21, Fibroblast Growth Factor-21; FFA, Free Fatty Acids; VLDL-TG, Very Low-Density Lipoprotein- Triglycerides; DEXA, Dual-energy X-ray absorptiometry.