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Currently no specific medical therapy has been shown effective in nonalcoholic fatty liver disease (NAFLD). In a phase I study, pegbelfermin (BMS-986036) — a polyethylene glycol–conjugated (PEGylated) fibroblast growth factor 21 analogue that is a key regulator of energy metabolism — showed promise by improving markers of metabolism and liver fibrosis in NAFLD. Now, data are available from a manufacturer-sponsored phase IIA trial in patients with nonalcoholic steatohepatitis (NASH).
Researchers randomized 75 adults with biopsy-proven NASH with stage 1 to 3 fibrosis, body-mass index ≥25 kg/m2, and ≥10% hepatic fat fraction to self-administered subcutaneous injection of placebo (daily), 10 mg of pegbelfermin (daily), or 20 mg of pegbelfermin (…