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. 2020 Jun 11;3(3):e00163. doi: 10.1002/edm2.163

TABLE 3.

Undergoing clinical trials investigating the efficacy, safety and tolerability of GLP‐1 RAs in the treatment of NAFLD

Title Conditions Interventions Characteristics Primary outcome Secondary outcome Location
NCT03590626 Effect of dulaglutide on liver fat in patients with type 2 diabetes and nonalcoholic fatty liver disease (D‐LIFT)
  • NAFLD

  • T2DM

  • Dulaglutide

  • Antidiabetic medicines

  • Randomized

  • Phase: NA

Change in liver fat quantified by MRI‐PDFF Changes in biochemical markers, LSM, CAP, etc India
NCT03648554 Researching an effect of GLP‐1 agonist on liver steatosis (REALIST)
  • T2DM

  • NASH

  • Dulaglutide

  • Reinforced

  • dietary monitoring

  • Randomized

  • Phase 4

Regression of NASH without worsening of fibrosis Changes in Kleiner score of fibrosis, fibrosis markers, and liver enzymes France
NCT03987451 A research study on how semaglutide works in people with fatty liver disease and liver damage
  • NASH

  • Semaglutide

  • Placebo

  • Randomized

  • Phase 4

Relative change in liver stiffness measured by MRE Relative change in LFC measured by MRI‐PDFF, NASH resolution, etc United States
NCT03357380 A study on how semaglutide works on early stages of scar tissue in the liver assessed by pictures of the liver
  • Hepatobiliary disorders

  • NAFLD

  • Semaglutide

  • Placebo

  • Randomized

  • Phase 1

Change in liver stiffness assessed by MRE Change in liver stiffness assessed by MRE and in LFC by MRI‐PDFF, and proportion of subjects with at least 30% reduction in relative LFC. Germany
NCT03884075 Nonalcoholic fatty liver disease, the hepatic response to oral glucose, and the effect of semaglutide (NAFLD HEROES)
  • NASH

  • NAFLD

  • Semaglutide

  • Single‐group assignment

  • Phase 2

Histological improvement(>=2 point decrease in NAFLD activity score) and clinical improvement NA United States
NCT02970942 Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with nonalcoholic steatohepatitis
  • Hepatobiliary disorders

  • NASH

  • Semaglutide

  • Placebo

  • Randomized

  • Phase2

NASH resolution without worsening of fibrosis liver fibrosis improvement, NAFLD activity score, etc United States
NCT03987074 Safety, tolerability and efficacy of monotherapy and combination regimens in adults with nonalcoholic steatohepatitis (NASH) NASH
  • Semaglutide

  • Firsocostat

  • Cilofexor

  • Randomized

  • Phase 2

The number of treatment‐emergent adverse events and serious Adverse events (SAEs), and any grade ≥ 1 laboratory abnormality NA United States
NCT02654665 Comparing effects of liraglutide and bariatric surgery on weight loss, liver function, body composition, insulin resistance, endothelial function and biomarkers of nonalcoholic steatohepatitis (NASH) in obese Asian adults (CGH‐LiNASH)
  • NAFLD

  • Weight Loss

  • NASH

  • Liraglutide

  • Lifestyle modification

  • Nonrandomized

  • Phase 3

Improvement in NASH and reduction/normalization in transaminases and liver fat NA Singapore

Abbreviations: CAP, controlled attenuation parameter; LFC, liver fat content; LSM, liver stiffness measurement; MRE, magnetic resonance elastography; MRI‐PDFF, magnetic resonance imaging proton density fat fraction; NA, not applicable.