Clinical trials for NAFLD or NASH treatments
Treatment | Class | Target | Trial number | References |
---|---|---|---|---|
δ-tocotrienol and α-tocopherol | Vitamin E | A 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 apoptosis | SLCTR/2019/038# | [229] |
Fish oil plus vitamin D3 | Fish oil and vitamin D3 | The 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-treated | ChiCTR1900024866* | [230] |
Efruxifermin | A long-acting Fc-FGF21 fusion protein | Treatment 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] |
Pegbelfermin | A PEGylated human FGF21 analog | The subcutaneous administration of pegbelfermin significantly reduced the hepatic fat fraction in patients with NASH | NCT02413372 | [232] |
Mediterranean diet (MD) and LFD | Diets | A 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 stress | NCT04845373 | [233] |
L-carnitine tartrate, nicotinamide riboside, L-serine, and N-acetyl-l-cysteine | CMAs | CMA significantly reduced hepatic steatosis and levels of aspartate aminotransferase, ALT, uric acid, and creatinine | NCT04330326 | [234] |
Tofogliflozin and glimepiride | An inhibitor of SGLT2 and anti-type 2 diabetes drug | Hepatic 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 treatment | NCT02649465 | [235] |
Lifestyle intervention (LSI) + pioglitazone (PGZ) | Lifestyle + PPAR-γ agonist | A 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 women | NCT00633282 | [236] |
Diacylglycerol acyltransferase 2 inhibitor (DGAT2i) and acetyl-coenzyme A carboxylase inhibitor (ACCi) | Inhibition of intrahepatic TG synthesis and blockade of DNL | A combined treatment of DGAT2i, PF-06865571, and ACCi (PF-05221304, clesacostat) was applied to treat NASH with liver fibrosis | NCT04321031 | [237] |
Helicobacter (H.) pylori eradication treatment | Bacterial alteration | H. 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-α | ChiCTR2200061243* | [238] |
Recombinant leptin therapy | Hormone therapy | Exogenous leptin treatment decreased hepatic steatosis and injury in patients with NASH who have relative leptin deficiency with partial lipodystrophy | NCT00596934 | [239] |
Cenicriviroc | C-C chemokine receptors type 2 and 5 dual antagonist | In response to cenicriviroc treatment, patients with NASH achieved ≥ 1-stage fibrosis improvement at year 1 and maintained it at year 2 | NCT02217475 | [240] |
# Sri Lanka Clinical Trials Registry; * Chinese clinical trial registration
CZ: Conceptualization, Investigation, Writing—original draft, Writing—review & editing. YS and SL: Investigation, Writing—original draft, Writing—review & editing. MY: Conceptualization, Validation, Writing—review & editing, Supervision. All authors read and approved the submitted version.
The authors declare that they have no conflicts of interest.
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© The Author(s) 2023.