Gilead Sciences has reported results from Phase II clinical trial of its oral, investigational acetyl-CoA carboxylase (ACC) inhibitor, GS-0976, assessed for the treatment of nonalcoholic steatohepatitis (NASH).
Compared with 5mg GS-0976 and placebo, 20mg once-a-day dose of GS-0976 was found to cause a statistically significant decrease in hepatic steatosis and the TIMP-1 fibrosis marker after 12 weeks.
The randomised, placebo-controlled Phase II trial investigated the two doses in 126 NASH patients with liver fibrosis stages F1 through F3.
According to the results, there were no statistically significant differences between 5mg GS-0976 and placebo.
Furthermore, no such differences were observed between the GS-0976 and placebo groups for measures such as liver stiffness by FibroScan and MRE, serum ALT, and a serum marker of fibrogenesis called PIII-NP.
The data further revealed a median relative change in triglycerides (TG) from baseline of +11% with 20mg GS-0976 at week 12, while it was +13% in case of 5mg GS-0976 and -4% for placebo.
Though asymptomatic Grade 3 or 4 TG elevations were experienced by 16 patients administered with the investigational candidate, they were resolved with fibrate, fish oil therapy or no additional therapy.
GS-0976 is reported to have demonstrated favourable tolerability profile with nausea, abdominal pain and diarrhea being the most common adverse events.
Lead study author and NAFLD Research Centre director Rohit Loomba said: “Unfortunately, there are no treatments available for these patients.
“In this first randomised, placebo-controlled, Phase II study of an ACC inhibitor in NASH, the data suggest that GS-0976 has the potential to play an important role in treating patients with this disease.”