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Dose-dependent reduction in body weight with LIK066 treatment in Japanese patients with obesity.
Diabetes, Obesity & Metabolism ( IF 6.133 ) Pub Date : 2020-03-12 , DOI: 10.1111/dom.14006
Koutaro Yokote,Misako Sano,Isao Tsumiyama,Deborah Keefe

AIMS LIK066 (licogliflozin) is a dual sodium glucose co-transporter 1/2 inhibitor with potential benefits in weight loss. This study evaluated the efficacy, tolerability and safety of licogliflozin in Japanese adults with obesity. MATERIALS AND METHODS This study was a randomized, double-blind, placebo controlled, dose-finding study to evaluate the effect of licogliflozin (2.5, 10, 25 and 50 mg qd) in 126 Japanese patients with obesity. The primary objective was to examine the dose-response relationship of licogliflozin treatment in body weight reduction relative to placebo at 12 weeks. The secondary objectives included assessment of responder rates, change in parameters related to complications, visceral and subcutaneous fat area, and safety through 12 weeks of treatment. RESULTS The placebo-subtracted least square mean percent change in body weight from baseline at Week 12 was -1.99 (95% confidence interval -2.92, -0.21), -3.00 ( -4.15, -1.70), -3.54 ( -4.54, -2.26), and -3.91% ( -5.01, -2.77) in licogliflozin 2.5, 10, 25 and 50 mg qd dose groups, respectively. The proportion of responders with ≥3% reduction in body weight in the licogliflozin 2.5, 10, 25 and 50 mg qd dose groups were 15.8%, 55.6%, 50.0% and 56.7%, respectively, versus placebo (7.1%; p≤0.002 for all except 2.5 mg qd group [p = 0.39]). Dose-dependent reductions were observed significantly in HbA1c, uric acid, FPG and potentially in waist circumference, DBP and visceral fat area. CONCLUSION Dual inhibition of SGLT1/2 with licogliflozin treatment induced a dose-dependent reduction in body weight in Japanese patients with obesity. Treatment with licogliflozin was safe and well tolerated in this study. (NCT03320941) This article is protected by copyright. All rights reserved.
更新日期:2020-04-22

 

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