Trial reportMenopause (New York, N.Y.)2026
Efficacy and safety of GS1-144, a novel neurokinin 3 receptor antagonist, for moderate-to-severe vasomotor symptoms associated with menopause in Chinese women: a randomized, double-blind, placebo-controlled phase 2 trial.
Trial report in Menopause (New York, N.Y.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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17 authors.
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Abstract
objectiveThis multicenter, randomised, double-blind, placebo-controlled, phase 2 trial investigated the efficacy and safety of the selective neurokinin 3 receptor (NK3R) antagonist GS1-144 for moderate-to-severe vasomotor symptoms (VMS).
methodsEligible participants aged between 40 and 64 years randomly (1:1:1:1) received GS1-144 30 mg once daily (QD), 60 mg QD, or 30 mg twice daily (BID) and placebo for 12 weeks. Co-primary endpoints were the mean change in the frequency and severity of moderate-to-severe VMS from baseline to weeks 4 and 12.
resultsAmong 276 randomized participants, 271 (98.2%) and 258 (93.5%) completed 4 and 12 weeks of treatment, respectively. VMS frequency was significantly reduced versus placebo for GS1-144 30 mg BID at week 4 (difference in change in least squares mean -1.31 [90% CI: -2.35 to -0.26], P =0.04) and week 12 (-1.41 [-2.28 to -0.54], P =0.008), and for GS1-144 60 mg QD at week 12 (-1.42 [-2.28 to 0.55], P =0.007). GS1-144 30 mg BID and 60 mg QD significantly reduced VMS severity versus placebo at week 4 (-0.14 [-0.26 to -0.01], P =0.07; -0.13 [-0.26 to -0.01], P =0.07) and week 12 (-0.24 [-0.43 to -0.05], P =0.04; -0.19 [-0.38 to 0.00], P =0.098). Treatment-emergent adverse events occurred in 67.6% (140/207) of participants who received GS1-144 and 62.3% (43/69) in the placebo group. No liver safety risks were observed with GS1-144.
conclusionsGS1-144 is well tolerated and significantly reduces VMS frequency and severity in postmenopausal Chinese women.
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