Table 2.
A list of FGF-19 and FGF-21 analogs in clinical trials for the management of NAFLD/NASH.
| Year | Refs | Phase | Conditions | Intervention(s) | Duration (Week) | Outcomes | |
|---|---|---|---|---|---|---|---|
| FGF-19 analog | |||||||
| Aldafermin (NGM282) |
2018 | [87] | 2 | biopsy-confirmed NASH, NAS ≥ 4, stage 1-3 fibrosis, absolute LFC ≥ 8% (n = 82) | NGM282 6 mg vs. NGM282 3 mg vs. placebo | 12 | 74% patients in the 3 mg dose group and 79% in the 6 mg dose group achieved at least a 5% reduction in absolute LFC from baseline |
| Aldafermin (NGM282) |
2020 | [44] | 2 | biopsy-confirmed NASH, NAS ≥ 4, stage 1–3 fibrosis, absolute LFC ≥ 8% (n = 43) | NGM282 3 mg vs. NGM282 1 mg | 12 | Histological features of NASH with significant reductions in NAS and fibrosis scores, accompanied by improvements in noninvasive imaging and serum markers |
| Aldafermin (NGM282) |
2021 | [43] | 2 | biopsy-proven NASH, NAS ≥ 4, stage 2 or 3 fibrosis, absolute LFC ≥ 8% (n = 78) | aldafermin 1 mg vs. placebo | 24 | Aldafermin reduced liver fat and produced a trend toward fibrosis improvement |
| Aldafermin (NGM282) |
2022 | [42] | 2b | biopsy-confirmed NASH, stage 2 or 3 fibrosis (n = 171) | aldafermin 0.3 mg vs. aldafermin 1 mg vs. aldafermin 3 mg vs. placebo | 24 | Aldafermin induced a robust imaging and biochemical response in patients with NASH and F2 or F3 fibrosis; no significant dose response of aldafermin on the histological fibrosis primary endpoint |
| FGF-21 analog | |||||||
| Pegbelfermin | 2018 | [49] | 2a | biopsy-confirmed NASH, BMI ≥ 25 kg/m2, fibrosis stage 1-3, HFF ≥ 10% (n = 184) | pegbelfermin (10 mg or 20 mg) vs. placebo | 16 | Pegbelfermin significantly reduced HFF in patients with NASH |
| Efruxifermin | 2021 | [88] | 2a | biopsy-confirmed NASH, fibrosis stage 1–3, NAS of ≥4, HFF of ≥10% (n = 80) | efruxifermin (28 mg, 50 mg, or 70 mg) vs. placebo | 16 | Efruxifermin significantly reduced HFF in patients with F1–F3 stage NASH |
BMI: body mass index; FGF-19: fibroblast growth factor-19; FGF-21: fibroblast growth factor-21; HFF: hepatic fat fraction; LFC: liver fat content; NAS: NAFLD activity score; NASH: nonalcoholic steatohepatitis.