SAXA PCOS Weight Loss Trial

SAXA PCOS weight loss trialFertility Answers is excited to announce the start of a new collaborative PCOS weight loss trial.

This study is launched in conjunction with the Weight Loss and Metabolic Clinic at Woman’s Hospital in Baton Rouge. This PCOS weight loss trial will be looking into the benefits of Saxenda® (Liraglutide 3 mg) in women with polycystic ovary syndrome. Liraglutide has been approved for weight loss in women with a body mass index greater than 30. However, previous studies of Liraglutide have not focused on women affected by PCOS. Together, with Dr. Drake Bellanger, bariatric surgeon at Woman’s Weight Loss and Metabolic Clinic, we plan to enroll 90 patients ages 18-45 with PCOS. Throughout the study, we will be looking for changes in weight and markers for pre-diabetes as well as improvement in the hormone profiles of PCOS. All visits, medications, and lab draws are totally covered by the study and patients will receive compensation for their time. The trial will last 32 weeks.

This study seeks to show if the FDA-approved weight loss drug Saxenda® is effective in reducing body weight and excessive male hormones in obese women with polycystic ovary syndrome (PCOS).

Obesity plays a central role in the development of PCOS, and affects fertility and metabolism. Evidence suggests that medical treatment using drugs that manage obesity may modify the physiological and behavioral processes that contribute to weight gain in women with PCOS.

Saxenda® is a prescription injectable medicine that is FDA-approved for weight loss. Research has shown that higher doses of drugs like Saxenda® for at least 20 weeks leads to weight loss in obese patients with or without type 2 diabetes. This PCOS weight loss trial will let us know if there is an opportunity to expand this medication to the treatment of obese PCOS patients.

This PCOS weight loss trial aims to determine how Saxenda® treatment for 32 weeks impacts:

  • Body weight
  • Free androgen levels
  • Menstrual cyclicity
  • Glucose regulation
  • Insulin sensitivity and secretion
  • Body composition
  • Cardiometabolic markers (lipids, blood pressure)

To participate in the study, patients must meet the following criteria:

  • Female
  • Age 18-45
  • Body Mass Index (BMI) of greater than 30
  • Diagnosed with PCOS by hyperandrogenism (elevated male hormone or excess facial hair) and irregular menstrual cyclicity (less than 8 cycles/year)
  • Non-diabetic
  • Willing to use effective non-hormonal contraception consistently for the study duration

Medication, office visits, lab tests and compensation are provided. For more information on the SAXA PCOS weight loss trial, please contact Dr. Karen Elkind-Hirsch or Donna Shaler in Woman’s Research Department at 225-231-5275.