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. 2022 Dec 21;27(2):35. doi: 10.3892/mmr.2022.12922

Table I.

Clinical trials of AMPK and SIRT1 activators on patients with NAFLD.

Protein Activator Subjects Treatment and duration of study Type of study Outcome (Refs.)
AMPK Metformin 173 children with NAFLD 500 mg twice a day for 96 weeks Randomized, placebo-controlled, double blind
  • –

    Decreased NAS

  • –

    Decreased cholesterol, LDL

 (57)
Metformin combined with N-acetylcysteine 53 patients with NAFLD 850-1,500 mg/day for 48 weeks Open-label multicenter randomized trial
  • –

    Decreased NAS

 (58)
PXL770 12 patients with NAFLD
  • –

    250 mg once a day

  • –

    250 mg twice a day

  • –

    500 mg once a day For 12 weeks

 Randomized, double-blind, placebo
  • –

    Decreased ALT, AST

  • –

    Decreased triglycerides and VLDL

  • –

    Increased ApoB, HDL-c

  • –

    Decreased DNL percentage

  • –

    Increase dHOMA-IR

 (65)
Metformin 63 patients with NAFLD 500 mg metformin once a day for 4–12 month Randomized, placebo-controlled
  • –

    Decreased ALP and ALT

  • –

    Decreased triglycerides

  • –

    Increased HDL-c

 (68)
Metformin 10 patients at a risk of developing NAFLD 500 mg once a day for 12 weeks Single center, open label trial
  • –

    Decreased VLDL and triglycerides

 (69)
Metformin 35 patients with NAFLD 850 mg daily for 24 weeks Prospective controlled trial
  • –

    Decreased ALT, AST

  • –

    Decreased total cholesterol, triglyceride

  • –

    Increased HDL

 (70)
Metformin 29 patients with type 2 diabetes and NAFLD
  • –

    250 mg twice a day

  • –

    500 mg three times a day

  • –

    1,000 mg twice a day For 24 weeks

 Single center, open-label, prospective, randomized trial
  • –

    Decreased ALT, AST

  • –

    Decreased triglycerides

 (71)
SIRT1 Resveratrol 50 patients with NAFLD 500 mg once a day for 12 weeks Randomized, placebo-controlled, double blind
  • –

    Reduced steatosis grade

  • –

    Reduce level of ALT and AST

  • –

    Reduced inflammatory markers

 (75)
Resveratrol 60 patients with NAFLD 150 mg Twice a day for 3 months Randomized, placebo-controlled, double blind
  • –

    Decreased ALT, AST, LDL-c, glucose level

  • –

    Reduction of adiponectin level and TNF-α

 (76)
Resveratrol 25 patients with NAFLD 500 mg once a day for 12 weeks Randomized, placebo-controlled, double blind
  • –

    Reduced hepatic steatosis

  • –

    Reduced level of ALT

 (48)
Resveratrol 28 patients with NAFLD 1,5 g daily for 6 months Randomized, placebo-controlled, double blind
  • –

    Decreased 3.8% lipid content

 (49)
Resveratrol 44 patients with NAFLD 50 mg and 200 mg once a day for 6 months Randomized
  • –

    Reduced triglycerides, LDL

 (86)
AMPK and SIRT1 Metformin + leucine + sildenafil (NS-0200) 91 patients with NAFLD
  • –

    Low dose NS-0200 (1.1 g leucine + 0.5 g metformin + 0.5 mg sildenafil)

  • –

    High dose NS-0200 (1.1 g leucine +0.5 g metformin + 1.0 mg sildenafil) Twice daily for 16 weeks

 Randomized, placebo-controlled, double blind
  • –

    Reduced 15,7% intra hepatic fat

  • –

    Increased fatty acid oxidation

 (103)

AMPK, AMP-activated protein kinase; NAFLD, non-alcoholic fatty liver disease; NAS, NAFLD Activity Score; DNL, de novo lipogenesis; HOMA-IR, homeostatic model assessment for insulin resistance; ALT, alanine aminotransferase; AST, aspartate aminotransferase; VLDL, very low-density lipoprotein; LDL, low-density lipoprotein; HDL-c, high-density lipoprotein cholesterol.