A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity

NCT03320941 ↗

Phase 2 Completed 126 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to support dose selection for Phase 3 development in Japanese adults with obesity disease.

Timeline

Start: 2017-12-07
Primary completion: 2018-07-25
Completion: 2018-07-25

Outcome

Met primary endpoint

registry analysis (other test); LIK066 2.5mg qd vs Placebo; Mean Difference (Net) -1.99 (95% CI -2.92 to -0.21) NCT03320941 ↗

paper The placebo-subtracted least square mean percentage change in body weight from baseline at week 12 was -1.99 PMID 32072763 ↗

Publications

Yokote K, Sano M, Tsumiyama I, Keefe D. Dose-dependent reduction in body weight with LIK066 (licogliflozin) treatment in Japanese patients with obesity. Diabetes Obes Metab. 2020 Jul;22(7):1102-1110. doi: 10.1111/dom.14006. Epub 2020 Mar 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	licogliflozin	Small molecule	2.5 mg	Oral
Subject	licogliflozin	Small molecule	10 mg	Oral
Subject	licogliflozin	Small molecule	25 mg	Oral
Subject	licogliflozin	Small molecule	50 mg	Oral