Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS

What this study is testing ClinicalTrials.gov NCT03480022 ↗

Description as written by the study sponsor.

There is a growing need to develop pharmacologic interventions to improve metabolic function in women with polycystic ovary syndrome (PCOS). Given that PCOS is a frequent condition and weight loss is essential but difficult to achieve, it is important to study if the effect on body weight reported in other studies can be confirmed in a selected population of hyperandrogenic patients, especially with medications currently approved for weight reduction. High dose liraglutide alone results in significant weight reduction in obese women without PCOS. There is limited data on weight loss with high dose liraglutide in non-diabetic females with PCOS treated with this agent . Studies on the effect of anti-obesity medication combined with lifestyle changes on body weight and composition and androgen excess in obese women diagnosed with PCOS are lacking. The investigators aim to elucidate the most efficacious weight reduction regime in obese PCOS women. The investigators further hope to determine which treatment(s) addressing the multifaceted disturbances of this disorder in patients with PCOS and obesity emerges as the preferable therapy.

Treatments tested

• Liraglutide Pen Injector [Saxenda] also known as Liraglutide 3mg, Saxenda Drug

  daily sc injection of liraglutide with final dose of 3mg daily

• Placebo Liraglutide Pen Injector also known as Placebo Saxenda, Placebo liraglutide 3 mg Drug

  daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo