Licogliflozin shows promise in polycystic ovary syndrome
Dual sodium-glucose co-transporter 1/2 (SGLT1/2) inhibition with licogliflozin appears to produce reductions in hyperinsulinaemia and hyperandrogenaemia in women with polycystic ovary syndrome (PCOS), as shown in a phase II study.
The study randomized 29 patients (mean age 27.6 years, body weight 105.2 kg, body mass index 38.1kg/m2) to receive licogliflozin 50 mg (n=15) or placebo (n=14) three times a day for 14 days. Changes in free testosterone (FT), other androgens, and variables of insulin resistance were assessed on days 15 and 22. Safety, tolerability, and compliance were evaluated on day 8.
Treatment with licogliflozin did not induce a significant change in FT concentration compared with placebo (treatment ratio [TR], 0.88, 90 percent confidence interval [CI], 0.70–1.11; p=0.353). However, active treatment lowered androstendione (A4) by 19 percent (TR, 0.81, 90 percent CI, 0.68–0.99; p=0.089) and dehydroepiandrosteron sulphate (DHEAS) by 24 percent (TR, 0.76, 90 percent CI, 0.65-0.89; p=0.008).
Furthermore, patients on licogliflozin vs placebo had 70-percent lower hyperinsulinaemia (highest insulin concentration [MAXI]: TR, 0.26, 90 percent CI, 0.20–0.34; p<0.001; area under the curve insulin [AUCI]: TR, 0.32, 90 percent CI, 0.25–0.41; p<0.001).
Common adverse events included diarrhoea and nausea.
The findings suggest that licogliflozin may represent a novel therapeutic option for patients with PCOS. More studies with a longer treatment duration and that consider milder PCOS phenotypes and clinical outcome variables, such as ovulation rate, are needed to establish the full potential of dual SGLT1/2 inhibitors in PCOS.