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    Home > Active Ingredient News > Digestive System Information > NEJM: The effect of subcutaneous injection of semaglutide on non-alcoholic steatohepatitis

    NEJM: The effect of subcutaneous injection of semaglutide on non-alcoholic steatohepatitis

    • Last Update: 2021-03-30
    • Source: Internet
    • Author: User
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    Non-alcoholic steatohepatitis (NASH) is a common disease associated with increased patient morbidity and mortality, but treatment options are very limited.
    The efficacy and safety of the glucagon-like peptide-1 receptor agonist semaglutide in patients with NASH are still unclear.

    Recently, a research article was published in the top medical journal NEJM.
    Researchers conducted a 72-week double-blind phase 2 clinical trial.
    The study included biopsy-proven F1, F2, or F3 NASH and liver fiber The patients were randomly divided into groups at a ratio of 3:3:3:1:1:1.
    The subjects received subcutaneous injection of semaglutide at a dose of 0.
    1, 0.
    2 or 0.
    4 mg or corresponding placebo once a day .

    The primary endpoint of the study is to eliminate NASH without deterioration of fibrosis.
    The identified secondary end point was that fibrosis improved by at least one stage, while NASH did not worsen.
    These end-point analyses are only performed in patients with F2 or F3 stage fibrosis.

    The study included 320 patients (230 of them with F2 or F3 stage fibrosis), who were randomly assigned to receive 0.
    1 mg (80 cases), 0.
    2 mg (78 cases), or 0.
    4 mg (82 patients) or receive placebo (80 patients) treatment.
    The percentage of patients who achieved NASH elimination without worsening fibrosis was 40% in the 0.
    1 mg group, 36% in the 0.
    2 mg group, 59% in the 0.
    4 mg group, and 17% in the placebo group ( For semaglutide 0.
    4 mg, relative to placebo, P<0.
    001).
    In the 0.
    4 mg group, 43% of patients experienced improvement in the stage of fibrosis, and 33% of the patients in the placebo group experienced improvement in the stage of fibrosis (P=0.
    48).
    The average weight loss percentage was 13% in the 0.
    4 mg group and 1% in the placebo group.
    The incidence of nausea, constipation and vomiting was higher in the 0.
    4 mg group than in the placebo group (nausea was 42% and 11%; constipation was 22% and 12%; vomiting was 15% and 2%, respectively).
    According to reports, 3 cases (1%) of patients treated with semaglutide developed malignant tumors, while no malignant tumors occurred in patients treated with placebo.
    Overall, 15% of patients in the semaglutide group reported tumors (benign, malignant, or unspecified), and 8% of patients in the placebo group reported tumors.

    Thus, the results of this phase 2 clinical trial on patients with NASH showed that the percentage of patients with NASH remission with semaglutide treatment was significantly higher than that of placebo.
    However, the trial did not show a significant difference between the groups in the percentage of patients with improved fibrosis stages.
    Original source: Philip N.
    Newsome, et al.
    A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis .
    NEJM.
    2021.
    https://  

    The results of this phase 2 clinical trial in patients with NASH showed that the percentage of patients with remission of NASH with semaglutide treatment was significantly higher than that of placebo.


    However, the trial did not show a significant difference between the groups in the percentage of patients with improved fibrosis stages.
    Original Source: A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis in this message
     
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