The Phase 3 study (NCT05952882) investigating a liraglutide and metformin combination for women with polycystic ovary syndrome (PCOS), obesity, and infertility reached its primary completion on 2025-12-31. This milestone indicates that the final data for the primary outcome measures have been collected.

Background

Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder affecting women of reproductive age and is a leading cause of infertility. The condition often co-occurs with obesity, which can exacerbate insulin resistance, increase the incidence of impaired glucose tolerance and type 2 diabetes, and contribute to ovulatory dysfunction and menstrual disorders. Obesity also negatively impacts outcomes of Assisted Reproductive Technology (ART) and is associated with a higher miscarriage rate. Weight loss is known to decrease insulin resistance and hyperandrogenism, improving ovulation rates and menstrual cycles.

Trial design

The study, identified as NCT05952882, is a Phase 3 trial that enrolled 188 participants. It investigates the effects of a liraglutide and metformin combination compared to metformin alone. The trial focuses on women diagnosed with Polycystic Ovary Syndrome, Obesity, and Female Infertility. The primary outcomes for this study were not specified in the available data.

What this means

The primary completion of this Phase 3 trial signifies that all data collection for the study's primary objectives has concluded. While specific results are not yet available, this step is crucial for the subsequent analysis and eventual publication of findings. The study aims to provide insights into the potential benefits of combining liraglutide with metformin for weight loss, metabolic-endocrine parameters, and pregnancy rates in women facing these complex health challenges.

Source

Information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The event for study NCT05952882, titled "Liraglutide and Metformin Combination on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With PCOS, Obesity and Infertility," was recorded as primary completion on 2025-12-31 on clinicaltrials.gov.