A retooled version of the non-alcoholic steatohepatitis (NASH) drug FGF19 improved liver health on numerous fronts in a recent trial, MedPage Today reports. Previous research had indicated that FGF19 may promote hepatocellular carcinoma (HCC, the most common form of liver cancer). The new version is known as NGM282.
The Phase II study included 82 people with NASH, mild to advanced fibrosis of the liver and a minimum absolute liver fat content of 8 percent. The partcipants were randomly assigned to receive either 3 milligrams or 6 mg of NGM282 daily for 12 weeks or a placebo.
Findings were presented at the 52nd International Liver Congress in Amsterdam.
After treatment, a respective 74 percent and 85 percent of those receiving the 3 mg and 6 mg doses achieved a drop in liver fat of at least 5 percent, compared with 7 percent of those who received the placebo. As for the proportion who ended the trial with an absolute fat content of 5 percent, this so-called normalization status was achieved by a respective 25.9 percent and 42.3 percent of those receiving the 3 mg and 6 mg doses and none of those who received the placebo.
Compared with those receiving the placebo, 89 percent of those who received either dose of NGM282 experienced a greater than 30 percent change in relative fat content, a threshold considered clinically relevant. In addition, those receiving the treatment experienced a rapid drop in multiple indicators linked with a resolution of NASH and fibrosis.
The treatment was well tolerated, with most of the adverse health events being mild. However, the researchers believe that one case of pancreatitis may have been related to treatment.
To read the MedPage Today article, click here.