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

Who can take part

Inclusion Criteria: * Age between 18 and 40 years. * Female. * No plan for pregnancy from the time of signing the informed consent until 2 months after the last dose of study drug, and willingness to use study-approved contraceptive methods during this period. * Fulfillment of at least two of the diagnostic criteria for PCOS according to the 2023 International Guideline, including: 1. Irregular menstrual cycles: 1-3 years after menarche: cycle length \<21 days or \>45 days; ≥3 years after menarche to perimenopause: cycle length \<21 days or \>35 days, or fewer than 8 menstrual cycles per year; ≥1 year after menarche: any cycle \>90 days; 2. Polycystic ovarian morphology: at least one ovary with ≥20 antral follicles (diameter \<10 mm), confirmed by transvaginal or transrectal pelvic ultrasonography; 3. Hyperandrogenism: biochemical hyperandrogenism (total testosterone \>1.67 nmol/L) or clinical hyperandrogenism (modified Ferriman-Gallwey \[mFG\] score \>4). Exclusion Criteria: * Use of hormonal contraceptives within 2 months prior to screening. * History of acute or chronic pancreatitis or pancreatic injury. * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2A or 2B. * History of type 1 or type 2 diabetes mellitus. * Presence of other endocrine disorders that may cause polycystic ovarian morphology, such as 21-hydroxylase deficiency, pituitary prolactinoma, hypothyroidism, or Cushing's syndrome. * Current use of other medications known to affect reproductive function, with discontinuation less than 2 months prior to screening, including GnRH agonists or antagonists, anti-androgens, and gonadotropins. * Current use of other medications that may affect metabolism, with discontinuation less than 1 month prior to screening, including metformin, thiazolidinediones, and SGLT2 inhibitors. * History of bariatric surgery within the past 12 months. * Treatment with GLP-1 receptor agonists within the past 12 months. * Pregnancy or lactation. * Presence of other serious diseases of major organs such as the heart, liver, or kidney, or any malignancy. * Any other condition that, in the investigator's opinion, may interfere with the evaluation of efficacy or safety or render the participant unsuitable for this study.

Registry changes

No changes recorded since the trial was added.