1 2 A randomized placebo-controlled double blind trial of liraglutide 3 mg 3 [Saxenda] on weight, body composition, hormonal and metabolic 4 parameters in obese women with polycystic ovary syndrome (PCOS) 5 6 7 8 9 INVESTIGATOR-SPONSORED STUDY PROPOSAL 10 11 Universal Trial Number (UTN) is U1111-1198-4126 12 13 14 15 Woman’s Health Research Department 16 Woman’s Hospital 17 100 Woman’s Way 18 Baton Rouge, Louisiana 19 20 Correspondence to: 21 22 Karen Elkind-Hirsch, PhD 23 Director of Research 24 Woman’s Hospital -Support Services Building 25 100 Woman’s Way 26 Baton Rouge, Louisiana 27 phone-(225) 231-5278 28 fax-(225) 231-5290 29 30
[email protected] 31 32 ClinicalTrials.gov ID: NCT03480022 33 34 1 Version 6, 5/15/18 35 Background and Significance: 36 Polycystic ovary syndrome (PCOS), a common, heterogeneous, heritable condition, is 37 characterized by disordered reproductive and metabolic function that accounts for the myriad of 38 clinical features including androgen excess, chronic anovulation, hyperinsulinemia, adiposity, 39 and dyslipidemia. Hyperandrogenism, ovarian dysfunction and metabolic abnormalities - the 40 main determinants of PCOS – all appear to be involved in a synergistic way in the 41 pathophysiology of PCOS. Women with PCOS are more likely to be obese although PCOS can 42 also manifest in lean women. Obesity, particularly abdominal obesity, plays a central role in the 43 development of PCOS, and exacerbates the reproductive and metabolic dysfunction. Rather 44 than absolute body weight, it is the distribution of fat that is important with central adiposity 45 being a risk factor.