Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS
Condition: Pre Diabetes; Polycystic Ovary Syndrome; Obesity Android
MeSH terms: Polycystic Ovary Syndrome; Prediabetic State; Syndrome; Body Weight
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      The drug, liraglutide 3.0 mg was approved for chronic weight management in management in
      obese adults with an initial BMI of 30 kg/m2 or greater or in overweight adults BMI of 27
      kg/m2 or greater with at least one weight-related co-morbid condition as an adjunct to a
      reduced-calorie diet and increased physical activity. Liraglutide is an acylated human
      glucagon-like peptide -1 (GLP-1) analog that binds to and activates the GLP-1 receptor. It
      lowers body weight through decreased caloric intake while stimulating insulin secretion and
      reducing glucagon via a glucose-dependent mechanism. For obesity management, patients may
      lose weight with GLP-1 receptor agonists due to other unique actions. Glucagon-like peptide-1
      receptor agonists (GLP-1RAs) can slow gastric emptying and increase satiety. While predictors
      of weight loss success for the general population are available (protein intake, weight loss
      medications), predictors of weight loss success may differ between normal and hyperandrogenic
      women. Glucagon-like peptide 1 agonists are linked with dose dependent weight lowering
      potential in different obesity related populations. The weight loss effects of GLP-1RAs
      previously demonstrated in diabetic and obese non-diabetic patients, offer a unique
      opportunity to expand the medical options available to patients with PCOS.

      Given this lack of information, the aim of the present study was to investigate the effects
      of liraglutide 3mg vs. placebo on body composition as well as hormonal and metabolic features
      in non-diabetic obese women with PCOS.The non-diabetic obese female with PCOS offers a unique
      model to study the relationship between insulin resistance and adiposity. The investigators
      propose a double-blind, placebo-controlled 30-week trial designed to directly examine the
      therapeutic effects of liraglutide 3 mg (LIRA 3 mg) compared to placebo on body weight,
      hormonal and cardiometabolic parameters in obese non-diabetic women with PCOS. All patients
      will receive diet and lifestyle counseling, including advice on exercise commencing during
      the lead-in period and continuing throughout the study. In this study, the investigators will
      examine the efficacy of LIRA 3mg on body weight and body composition, reproductive function
      metabolic parameters and cardiovascular risk factors in a well-defined group of
      pre-menopausal obese non-diabetic women with hyperandrogenism, focusing on the relationship
      to obesity and insulin resistance.
    

Intervention name(s): Liraglutide Pen Injector [Saxenda]; Placebo Liraglutide Pen Injector
Intervention type(s): Drug; Drug
Intervention description(s): daily sc injection of liraglutide with final dose of 3mg daily; daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo
Other intervention name(s): Liraglutide 3mg; Saxenda; Placebo Saxenda; Placebo liraglutide 3 mg
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: prediabetes; PCOS; GLP-1 agonist; weight loss