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Updated: May 29, 2025

Optimized Analysis of In Vivo and In Vitro Hepatic Steatosis
Published on: March 11, 2017
FGF21 Analogues in Patients With Metabolic Diseases: Systematic Review and Meta-Analysis of Randomised Controlled
Panagiotis Theofilis1, Evangelos Oikonomou2, Paschalis Karakasis3
11st Department of Cardiology, "Hippokration" General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Background And Aims:
Liver-related complications are frequent in patients with metabolic diseases, with limited treatment options currently available. This systematic review and meta-analysis aimed to assess the effect of fibroblast growth factor-21 (FGF21) analogues on hepatic steatosis, inflammation and fibrosis in patients with metabolic diseases.
Methods:
We conducted a systematic literature search in Pubmed, Scopus and Web of Science for randomised controlled trials (RCTs) assessing the effect of FGF21 analogues on hepatic steatosis evaluated by hepatic fat fraction (HFF), inflammation and fibrosis compared to placebo. Adverse events (AEs) were also recorded.
Results:
Treatment with FGF21 analogues was associated with metabolic-associated steatohepatitis (MASH) resolution without fibrosis worsening (5 studies, risk ratio [RR] 4.40, 95% confidence interval [CI]: 2.41, 8.03, p < 0.001) and fibrosis improvement by 1 grade without MASH worsening (6 studies, RR 1.79, 95% CI: 1.24, 2.59, p = 0.002). FGF21 analogues significantly lowered HFF compared to placebo (6 studies, SMD -1.08, 95% CI: -1.28, -0.88, p < 0.001), while patients receiving FGF21 analogues were more likely to exhibit a reduction in HFF by 30% (10 studies, RR 4.08, 95% CI: 3.08, 5.40, p < 0.001) or 50% (6 studies, RR 10.43, 95% CI: 5.47, 19.87, p < 0.001). HFF normalisation (≤ 5%) was more frequently achieved with FGF21 analogues (6 studies, RR 14.58, 95% CI: 4.70, 45.18, p < 0.001). The results remained robust after sensitivity analyses. Serious AE and AE leading to drug discontinuation were similar in patients receiving FGF21 analogues or placebo.
Conclusions:
FGF21 analogues can reduce hepatic steatosis, inflammation and fibrosis in patients with metabolic diseases, representing a possible treatment option for steatotic liver disease.
Insights
Fibroblast growth factor-21 (FGF21) analogues show promise in treating liver complications associated with metabolic diseases. These FGF21 analogues effectively reduce hepatic steatosis, inflammation, and fibrosis, offering a potential new therapeutic option.
Area of Science:
- Hepatology
- Metabolic Diseases
- Pharmacology
Background:
- Liver-related complications are prevalent in metabolic diseases.
- Current treatment options for these liver complications are limited.
- Fibroblast growth factor-21 (FGF21) analogues are being investigated as a therapeutic strategy.
Purpose of the Study:
- To systematically review and meta-analyze the efficacy of FGF21 analogues.
- To assess the impact of FGF21 analogues on hepatic steatosis, inflammation, and fibrosis.
- To evaluate FGF21 analogues as a treatment for patients with metabolic diseases.
Main Methods:
- Systematic literature search of randomized controlled trials (RCTs) in PubMed, Scopus, and Web of Science.
- Analysis focused on FGF21 analogues versus placebo for hepatic steatosis (hepatic fat fraction - HFF), inflammation, and fibrosis.
- Adverse events (AEs) were also systematically recorded and compared.
Main Results:
- FGF21 analogues significantly reduced hepatic fat fraction (HFF) compared to placebo.
- Treatment was associated with metabolic-associated steatohepatitis (MASH) resolution and fibrosis improvement.
- Rates of serious AEs and drug discontinuation were similar between FGF21 analogue and placebo groups.
Conclusions:
- FGF21 analogues demonstrate significant efficacy in reducing hepatic steatosis, inflammation, and fibrosis.
- These findings suggest FGF21 analogues are a promising therapeutic option for steatotic liver disease in metabolic disorders.
- Further research may solidify FGF21 analogues as a viable treatment for metabolic-associated liver conditions.
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