Utilizing the metabolism effect of Pegozafermin to Address Non-Alcoholic Steatohepatitis (NASH)
|
Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on October 9th, 2023
|
As industrialization and economic development have led to an increase in the rate of obesity, metabolic diseases like non-alcoholic steatohepatitis (NASH) have been on the rise in Vietnam. NASH is characterized by the accumulation of excess fat in the liver, leading to inflammation and potential fibrosis. Pegozafermin, a fibroblast growth factor 21, has the potential to enhance fat catabolism. A recent study aimed to investigate whether pegozafermin's metabolic effects could be harnessed for the treatment of NASH.
This phase 2 clinical trial involved 222 patients diagnosed with non-alcoholic steatohepatitis within the past 6 months. The participants had an average body mass index of 38.1, with 69% of them also diagnosed with diabetes. Baseline assessments revealed that most of their alanine aminotransferase and aspartate aminotransferase levels were within the normal range. Further hepatic testing showed an average NAFLD activity score of 5.0 and an average liver fat content of 16.7%. Participants were randomly assigned to receive either a placebo or pegozafermin. Those receiving pegozafermin were further divided into three dose levels: 15 mg weekly, 30 mg weekly, and 44 mg every 2 weeks. After 24 weeks of treatment, the researchers observed that pegozafermin reduced liver fibrosis, with the most significant improvement observed in the highest dosage group. Moreover, pegozafermin resolved NASH in more than 30% of participants, a significantly higher rate than the placebo group. In terms of safety, most reported adverse events were mild, with nausea and diarrhea being the most commonly reported side effects.
This phase 2 clinical trial involved 222 patients diagnosed with non-alcoholic steatohepatitis within the past 6 months. The participants had an average body mass index of 38.1, with 69% of them also diagnosed with diabetes. Baseline assessments revealed that most of their alanine aminotransferase and aspartate aminotransferase levels were within the normal range. Further hepatic testing showed an average NAFLD activity score of 5.0 and an average liver fat content of 16.7%. Participants were randomly assigned to receive either a placebo or pegozafermin. Those receiving pegozafermin were further divided into three dose levels: 15 mg weekly, 30 mg weekly, and 44 mg every 2 weeks. After 24 weeks of treatment, the researchers observed that pegozafermin reduced liver fibrosis, with the most significant improvement observed in the highest dosage group. Moreover, pegozafermin resolved NASH in more than 30% of participants, a significantly higher rate than the placebo group. In terms of safety, most reported adverse events were mild, with nausea and diarrhea being the most commonly reported side effects.