Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025
Efficacy and Safety of HSK31679 in Asian Patients With MASLD: A Randomized Controlled Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод пока не подготовлен
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Xue Feng, Ma Wei, Gao Jixian, Chen Jinjun, Yue Wei, Bu Peili, Chen Qincong, Chen Hao, Sheng Jianlong, Chen Liang, Liu Fei, Li Guangming, Zhu Chuanwu, Zhong Bihui, Zhang Jianming, Cai Qingxian, Wang Le, Chen Ying, Pei Zhaohui, Yao Lvfeng, Lv Lingchun, Gao Yanhang, Xia Bihua, Ji Xianyou, Liu Yang, Du Laijing, Ma Genshan, Hao Kunyan, Li Fangqiong, Wu Tingting, Huo Yong, Wei Lai
Аннотация
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.
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.