Clinical trials for NAFLD or NASH treatments

TreatmentClassTargetTrial numberReferences
δ-tocotrienol and α-tocopherolVitamin EA combined treatment of two compounds improved hepatic steatosis, oxidative stress, and insulin resistance in patients with NAFLD. δ-tocotrienol was more effective than α-tocopherol in decreasing body weight, inflammation, and apoptosisSLCTR/2019/038#[229]
Fish oil plus vitamin D3Fish oil and vitamin D3The supplementation of two products reduced biomarkers of hepatocellular damage and plasma TAG levels in patients with NAFLD, which had additional benefits for insulin levels and inflammation compared to fish-oil-treatedChiCTR1900024866*[230]
EfruxiferminA long-acting Fc-FGF21 fusion proteinTreatment with efruxifermin significantly decreased hepatic fat fraction measured by magnetic resonance imaging-proton density fat fraction in patients with NASH and fibrosis (F1–F3 stages)NCT03976401[231]
PegbelferminA PEGylated human FGF21 analogThe subcutaneous administration of pegbelfermin significantly reduced the hepatic fat fraction in patients with NASHNCT02413372[232]
Mediterranean diet (MD) and LFDDietsA 12-week consumption of MD and LFD in adolescents with obesity and NAFLD reduced the BMI, fat mass, hepatic steatosis, and insulin resistance, decreased high transaminase levels, and improved inflammation and oxidative stressNCT04845373[233]
L-carnitine tartrate, nicotinamide riboside, L-serine, and N-acetyl-l-cysteineCMAsCMA significantly reduced hepatic steatosis and levels of aspartate aminotransferase, ALT, uric acid, and creatinineNCT04330326[234]
Tofogliflozin and glimepirideAn inhibitor of SGLT2 and anti-type 2 diabetes drugHepatic steatosis, hepatocyte ballooning, and lobular inflammation were decreased post-tofogliflozin treatment, whereas only hepatocellular ballooning was improved after the glimepiride treatment. In addition, the expression of genes related to energy metabolism, inflammation, and fibrosis was overturned after the tofogliflozin treatmentNCT02649465[235]
Lifestyle intervention (LSI) + pioglitazone (PGZ)Lifestyle + PPAR-γ agonistA combined PGZ and LSI treatment significantly decreased liver fat in both women and men compared to the LSI treatment alone, but it proved less effective in men than in womenNCT00633282[236]
Diacylglycerol acyltransferase 2 inhibitor (DGAT2i) and acetyl-coenzyme A carboxylase inhibitor (ACCi)Inhibition of intrahepatic TG synthesis and blockade of DNLA combined treatment of DGAT2i, PF-06865571, and ACCi (PF-05221304, clesacostat) was applied to treat NASH with liver fibrosisNCT04321031[237]
Helicobacter (H.) pylori eradication treatmentBacterial alterationH. pylori eradication significantly decreased FBG, glycosylated hemoglobin, HOMA-IR, TGs, BMI, and inflammatory markers such as high-sensitivity CRP, and inflammatory cytokines such as IL-6 and TNF-αChiCTR2200061243*[238]
Recombinant leptin therapyHormone therapyExogenous leptin treatment decreased hepatic steatosis and injury in patients with NASH who have relative leptin deficiency with partial lipodystrophyNCT00596934[239]
CenicrivirocC-C chemokine receptors type 2 and 5 dual antagonistIn response to cenicriviroc treatment, patients with NASH achieved ≥ 1-stage fibrosis improvement at year 1 and maintained it at year 2NCT02217475[240]

# Sri Lanka Clinical Trials Registry; * Chinese clinical trial registration