Global Study Evaluates Obeticholic Acid Treatment for NASH with Fibrosis (REGENERATE)
For Nate Collins, routine labs indicated fatty liver disease or NASH six months ago. “It was definitely unexpected, but not terrifyingly so,” he said.
The biopsy taken as part of a research study revealed NASH, and he was placed on the study’s treatment protocol.
Collins is one of six CHI Health patients enrolled in this study, which is evaluating obeticholic acid treatment for nonalcoholic steatohepatitis with fibrosis.
“We are the only center in Nebraska invited to participate in this study. It’s is a phase three, five-year multicenter worldwide trial,” said Sandeep Mukherjee, MD, CHI Health gastroenterologist/hepatologist.
The REGENERATE study will assess whether obeticholic acid treatment decreases fat and scarring in the liver, specifically evaluating the effect of obeticholic acid treatment compared to placebo on histological improvement and liver-related clinical outcomes in patients with non-cirrhotic NASH with liver fibrosis.
After starting the obeticholic acid, Collins noticed a decrease in his appetite and has subsequently lost 25 pounds. “So far, I’ve had no negatives, only positives,” he said.
This is one of several research studies taking on this serious health concern.
“Fatty liver disease is a global epidemic. It’s a chronic, insidious disease,” Mukherjee said.
“What’s alarming is people with an average build and body mass index are now getting fatty liver disease. It’s happening all over the world and it’s been seen in India and southwest Asia. There’s a study from India of thin, underweight farmers who have fatty liver disease and we don’t yet know why.”
Mukherjee is currently enrolling patients in this study, Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment (REGENERATE), and will be involved in another study later this year.