Hepatic steatosis common in patients with severe hypertriglyceridemia
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Among patients with severe hypertriglyceridemia who underwent MRI proton density fat fraction, clinically meaningful hepatic steatosis appeared to be common, according to a presenter at the National Lipid Association Scientific Sessions.
Cynthia L. Hartsfield, PhD, associate director of medical affairs at 89bio, presented an interim analysis of the ENTRIGUE phase 2 study of BIO89-100 (89bio), a fibroblast growth factor 21 agonist.
“BIO89-100 targets important metabolic parameters associated with both metabolic syndrome and nonalcoholic fatty liver disease/nonalcoholic steatohepatitis,” Hartsfield said during the presentation.
The analysis included 14 patients (mean age, 57 years; 43% women) with severe hypertriglyceridemia who underwent MRI proton density fat fraction (MRI-PDFF). To qualify for the study, patients needed a mean of two or three fasting triglycerides 500 mg/dL to 2,000 mg/dL; one patient from the MRI-PDFF analysis did not qualify for the main study, Hartsfield said.
All 14 patients had clinically meaningful hepatic steatosis, defined as MRI-PDFF of at least 5%, and ranged from 6.2% to 39.2%, she said.
“The prevalence and severity of hepatic steatosis was greater than expected and baseline MRI-PDFF values did not correlate with baseline triglyceride values,” Hartsfield said during the presentation. “Given the potential broad metabolic benefits of BIO89-100, it will be important to understand the correlation between nonalcoholic fatty liver disease and the risk of acute pancreatitis and to explore the potential benefit that liver fat reductions may have in patients with severe hypertriglyceridemia. These initial baseline findings in ENTRIGUE suggest that routine assessment of hepatic steatosis may be warranted in patients with severe hypertriglyceridemia.”
She also said a phase 1b/2a study of BIO89-100 in patients with nonalcoholic steatohepatitis showed the agent had favorable effects on liver fat, lipids and glycemic control parameters, with “a substantial reduction of liver fat and liver volume across dose groups.”
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Hartsfield C, et al. Late-Breakers & Partner Abstracts. Presented at: National Lipid Association Scientific Sessions; Sept. 24-26, 2021; Orlando, Fla. (hybrid meeting).
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