Study of HEC88473, a Dual GLP-1 and FGF21 Agonist, for Treating Women Aged 18-40 With Polycystic Ovary Syndrome

What this Trial Is About

Polycystic ovary syndrome PCOS is a common hormonal and metabolic disorder affecting women of reproductive age. It features irregular or absent ovulation, high levels of male hormones, and polycystic ovaries, often accompanied by issues like insulin resistance and obesity. Researchers are studying a new drug called HEC88473, which acts on both the GLP-1 and FGF21 receptors, to see if it can improve PCOS symptoms and metabolic problems in women. The study evaluates HEC88473 given as a weekly injection starting at 15 mg for 3 weeks, then increasing to 30 mg for 3 weeks, and finally to 45 mg for 18 weeks if tolerated. This treatment aims to affect androgen metabolism and other PCOS-related factors. The trial is a Phase 2 study focusing on women with PCOS and includes a 24-week treatment period. Participants will be monitored regularly to assess changes in free androgen index, menstrual cycle frequency, ovarian features by ultrasound, hormone levels, insulin resistance, lipid profiles, body weight, waist circumference, and quality of life. Safety and adverse events will also be tracked throughout the 24 weeks. The study involves multiple follow-up visits to measure these outcomes and evaluate the drugs effects on PCOS symptoms and metabolism.

Efficacy of a GLP-1/FGF21 Dual Agonist for Treating PCOS