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The treatment of non-alcoholic steatohepatitis (NASH) has not yet met clinical needs
.
Lanilano is a pan-PPAR (peroxisome proliferator-activated receptor) agonist that regulates key metabolic, inflammatory and fibrotic pathways in the pathogenesis of NASH
.
Recently, a research article was published in the top medical journal NEJM.
In this phase 2b, double-blind, randomized, placebo-controlled trial, patients with non-cirrhotic and highly active NASH were randomly assigned to receive a 1:1:1 ratio.
1200mg or 800mg ranilanol or placebo, once a day for 24 weeks
.
The primary endpoint of the study is the SAF-A score (the active part of the scoring system for steatosis, mobility, and fibrosis [SAF], including the swelling and inflammation scores) decreased by at least 2 points, but the fibrosis did not worsen; SAF-A score range From 0 to 4, the higher the score, the more severe the disease activity
.
Secondary endpoints include resolution of NASH and fibrosis
.
A total of 247 patients in the study were randomized, of which 103 (42%) patients had type 2 diabetes , and 188 (76%) patients had significant (moderate) or advanced fibrosis
.
Compared with patients who received placebo, the percentage of patients whose SAF-A score decreased by at least 2 points and did not worsen fibrosis was significantly higher in patients who received 1200 mg, but it was higher in patients who received 800 mg of La Nilanol Otherwise (1200mg vs.
placebo, 55% vs.
diabetes
In this phase 2b trial involving patients with active NASH, the percentage of patients whose SAF-A score decreased by at least 2 points and who did not experience fibrosis deterioration was significantly higher than that of placebo
.
These results support the further evaluation of Ranilanno's effect in a phase 3 trial
.
In this phase 2b trial involving patients with active NASH, the percentage of patients whose SAF-A score decreased by at least 2 points and who did not experience fibrosis deterioration was significantly higher than that of placebo