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Efficacy and Safety of HSK31679 in Asian Patients With MASLD: A Randomized Controlled Trial
Feng Xue1, Wei Ma2, Jixian Gao3
1Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Key Laboratory of Digital Intelligence Hepatology (Ministry of Education), School of Clinical Medicine, Tsinghua Medicine, Tsinghua University, Beijing, China; Department of Gastroenterology, Binzhou Medical University Hospital, Binzhou, China.
Background & Aims:
This study evaluated the efficacy and safety of the thyroid hormone receptor β agonist HSK31679 in Asian patients with metabolic dysfunction-associated steatotic liver disease (MASLD).
Methods:
This was a phase 2a, multicenter, randomized, double-blind, placebo-controlled study at 26 centers in China. Subjects with a liver fat content (LFC) of ≥8% at screening, when assessed by magnetic resonance imaging-proton density fat fraction, were eligible. Subjects were randomly assigned in a 1:1:1:1:1 ratio using a centralized randomization system to receive daily oral HSK31679 40 mg, HSK31679 80 mg, HSK31679 160 mg, ezetimibe 10 mg, or placebo. The primary endpoint was a relative change from baseline in LFC after 12 weeks of treatment.
Results:
A total of 210 participants were randomly assigned to placebo (n = 42), HSK31679 40 mg (n = 42), HSK31679 80 mg (n = 42), HSK31679 160 mg (n = 42), or ezetimibe (n = 42). At week 12, the mean relative change from baseline in LFC was -4.1% in the placebo group, -14.0% in the 40 mg group (mean difference vs placebo -9.9% [95% confidence interval (CI), -21.5% to 1.6%]; P = .092), -22.7% in the 80 mg group (-18.6% [95% CI, -30.2% to -7.0%]; P = .002), and -29.2% in the 160 mg group (-25.2% [95% CI, -36.8% to -13.5%]; P < .001). The most common treatment-emergent adverse event was diarrhea (11 [26.2%] of patients in the 40 mg group, 13 [31.0%] in the 80 mg group, 16 [38.1%] in the 160 mg group, and 2 [4.8%] in the placebo group). No drug-related serious adverse events or grade ≥3 adverse events were reported.
Conclusions:
In Asian MASLD patients, HSK31679 was well tolerated, with significant reductions in LFC after 12 weeks of treatment with 80 mg and 160 mg.
Clinicaltrials:
gov, Number: NCT05795517.
