Dose‐dependent reduction in body weight with LIK066 (licogliflozin) treatment in Japanese patients with obesity

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 once daily) 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 during 12 weeks of treatment. RESULTS: The placebo‐subtracted least square mean percentage 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 once‐daily dose groups, respectively. The proportion of responders with ≥3% reduction in body weight in the licogliflozin 2.5, 10, 25 and 50 mg once‐daily dose groups were 15.8%, 55.6%, 50.0% and 56.7%, respectively, versus placebo [7.1%; P ≤0.002 for all except the 2.5 mg once‐daily group (P = 0.39)]. Dose‐dependent reductions were observed significantly in haemoglobin A1c, uric acid, fasting plasma glucose and potentially in the waist circumference, diastolic blood pressure 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. The study is registered with ClinicalTrials.gov (NCT03320941).