drugset / Trial / NCT06125587

Chiglitazar/Metformin in Non-obese Women With PCOS

NCT06125587

Phase 2/3 Completed 55 enrolled Shengjing Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorders in women of reproductive age, and its prevalence rate is from 9% (NIH criteria) to 18% (Rotterdamcriteria). It is clinically characterized by hyperandrogenism, persistent anovulation, and polycystic ovarian changes. Moreover it is often accompanied by insulin resistance and obesity. Now, metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome. Chiglitazar is a novel peroxisome proliferation activated receptor (PPAR) agonist. Treatment of type 2 diabetes mellitus by moderate activation of PPARα, PPARγ and PPARδ, improving insulin sensitivity, regulating blood glucose, and promoting fatty acid oxidation and utilization. However, there is limited evidence for its treatment of insulin resistance in women with PCOS. Therefore, investigators applied chiglitazar and metformin to two groups of PCOS patients to understand their effects on insulin resistance.

Timeline

Start
2023-11-15
Primary completion
2024-10-31
Completion
2024-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Chiglitazar Unknown 32 mg Oral
Comparator Metformin Small molecule 0.5 g Oral