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▎ WuXi AppTec content team editors About a quarter of the world’s population suffers from non-alcoholic fatty liver disease (NAFLD).
As the disease progresses, simple liver steatosis will gradually develop into non-alcoholic steatohepatitis (NASH).
Gradually cause liver fibrosis, and eventually may develop into liver cirrhosis or even hepatocellular carcinoma.
Among them, NASH is an important intermediate stage of disease progression and is related to increased mortality.
NASH is difficult to recover on its own, but treatment options are limited.
Recently, the positive results of the Phase 2 clinical trial of Semaglutide in the treatment of NASH patients were published in the New England Journal of Medicine.
Screenshot source: The New England Journal of Medicine Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, which has been approved for the treatment of type 2 diabetes, and has also been approved by the US FDA before.
A breakthrough therapy designation granted for the treatment of NASH.
This double-blind phase 2 clinical trial enrolled 320 patients with NASH diagnosed by biopsy, of which 230 patients had liver fibrosis (including F1, F2, or F3).
Patients 3:3:3:1:1:1 were randomly assigned to receive a subcutaneous injection of 0.
1 mg (80 cases), 0.
2 mg (78 cases) or 0.
4 mg (82 cases) of semaglutide once a week, or corresponding doses Placebo (80 cases in total) for 72 weeks.
The primary endpoint of the trial was the disappearance of NASH at the histopathological level (resolution of NASH) and no progression of liver fibrosis.
The secondary endpoint is that liver fibrosis has improved by at least one stage and NASH has not worsened.
The analysis of these two endpoints is only performed in patients with F2 or F3 liver fibrosis.
Other indicators were analyzed in all patients.
The results showed that 40% of patients in the semaglutide 0.
1 mg group, 36% of the 0.
2 mg group, and 59% of the 0.
4 mg group reached the histopathological level of NASH disappearance and liver fibrosis did not progress.
This proportion was only 17% in the placebo group, which was significantly different from the 0.
4 mg semaglutide group.
43% of patients in the semaglutide 0.
4 mg group and 33% of the placebo group had an improvement in the stage of liver fibrosis, and the difference was not significant.
The average weight loss was 13% in the 0.
4 mg semaglutide group and 1% in the placebo group.
In terms of safety, the incidence of nausea, constipation and vomiting in the 0.
4 mg semaglutide group was higher than that in the placebo group (nausea 42% vs 11%; constipation 22% vs 12%; vomiting 15% vs 2%).
15% of patients in the semaglutide group reported tumors (benign, malignant, or unspecified), compared to 8% in the placebo group; 3 patients (1%) in the semaglutide group had malignant tumors.
No malignancy was reported in the placebo group.
No pattern of tumor occurrence in specific organs was observed.
Overall, this trial showed that compared with placebo, semaglutide treatment can significantly more patients with NASH disappeared at the histopathological level, but showed no significant difference between groups in improving the staging of liver fibrosis.
. Related Reading "The Lancet" Sub-Journal: No need to "suffer" biopsy, identify high-risk fatty liver, non-invasive blood test technology brings hope "The Lancet" Sub-Journal: Significantly reduce triglycerides, delay the progress of fatty liver, antisense The Phase 2 trial of a new nucleotide drug published a Stanford study: Beware of thin people, 40% of fatty liver patients are not fat, and there are many long-term complications! Source of title picture: 123RF reference materials [1] Philip N.
Newsome, et al.
, (2021).
A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis.
The N Engl J Med, DOI: 10.
1056/NEJMoa2028395 Note: The purpose of this article The introduction of medical and health research progress is not a treatment plan recommendation.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
As the disease progresses, simple liver steatosis will gradually develop into non-alcoholic steatohepatitis (NASH).
Gradually cause liver fibrosis, and eventually may develop into liver cirrhosis or even hepatocellular carcinoma.
Among them, NASH is an important intermediate stage of disease progression and is related to increased mortality.
NASH is difficult to recover on its own, but treatment options are limited.
Recently, the positive results of the Phase 2 clinical trial of Semaglutide in the treatment of NASH patients were published in the New England Journal of Medicine.
Screenshot source: The New England Journal of Medicine Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, which has been approved for the treatment of type 2 diabetes, and has also been approved by the US FDA before.
A breakthrough therapy designation granted for the treatment of NASH.
This double-blind phase 2 clinical trial enrolled 320 patients with NASH diagnosed by biopsy, of which 230 patients had liver fibrosis (including F1, F2, or F3).
Patients 3:3:3:1:1:1 were randomly assigned to receive a subcutaneous injection of 0.
1 mg (80 cases), 0.
2 mg (78 cases) or 0.
4 mg (82 cases) of semaglutide once a week, or corresponding doses Placebo (80 cases in total) for 72 weeks.
The primary endpoint of the trial was the disappearance of NASH at the histopathological level (resolution of NASH) and no progression of liver fibrosis.
The secondary endpoint is that liver fibrosis has improved by at least one stage and NASH has not worsened.
The analysis of these two endpoints is only performed in patients with F2 or F3 liver fibrosis.
Other indicators were analyzed in all patients.
The results showed that 40% of patients in the semaglutide 0.
1 mg group, 36% of the 0.
2 mg group, and 59% of the 0.
4 mg group reached the histopathological level of NASH disappearance and liver fibrosis did not progress.
This proportion was only 17% in the placebo group, which was significantly different from the 0.
4 mg semaglutide group.
43% of patients in the semaglutide 0.
4 mg group and 33% of the placebo group had an improvement in the stage of liver fibrosis, and the difference was not significant.
The average weight loss was 13% in the 0.
4 mg semaglutide group and 1% in the placebo group.
In terms of safety, the incidence of nausea, constipation and vomiting in the 0.
4 mg semaglutide group was higher than that in the placebo group (nausea 42% vs 11%; constipation 22% vs 12%; vomiting 15% vs 2%).
15% of patients in the semaglutide group reported tumors (benign, malignant, or unspecified), compared to 8% in the placebo group; 3 patients (1%) in the semaglutide group had malignant tumors.
No malignancy was reported in the placebo group.
No pattern of tumor occurrence in specific organs was observed.
Overall, this trial showed that compared with placebo, semaglutide treatment can significantly more patients with NASH disappeared at the histopathological level, but showed no significant difference between groups in improving the staging of liver fibrosis.
. Related Reading "The Lancet" Sub-Journal: No need to "suffer" biopsy, identify high-risk fatty liver, non-invasive blood test technology brings hope "The Lancet" Sub-Journal: Significantly reduce triglycerides, delay the progress of fatty liver, antisense The Phase 2 trial of a new nucleotide drug published a Stanford study: Beware of thin people, 40% of fatty liver patients are not fat, and there are many long-term complications! Source of title picture: 123RF reference materials [1] Philip N.
Newsome, et al.
, (2021).
A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis.
The N Engl J Med, DOI: 10.
1056/NEJMoa2028395 Note: The purpose of this article The introduction of medical and health research progress is not a treatment plan recommendation.
If you need guidance on treatment plans, please go to a regular hospital for treatment.
