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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorShanghai Zhongshan Hospital

About this trial

Polycystic ovary syndrome (PCOS) is the most common reproductive endocrine and metabolic disorder among women of reproductive age. It is characterized by oligo-ovulation or anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology. In addition, PCOS is frequently accompanied by multiple metabolic abnormalities, including insulin resistance, obesity, impaired glucose tolerance, and dyslipidemia. Clinical studies have demonstrated that treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs) in women with PCOS results in significant weight reduction, decreased free testosterone levels, improvement in menstrual regularity, and increased clinical pregnancy rates. Fibroblast growth factor 21 (FGF21) has been shown to enhance insulin sensitivity, promote fatty acid oxidation, and improve lipid distribution.

HEC88473 is a novel long-acting dual agonist targeting both the glucagon-like peptide-1 (GLP-1) receptor and the fibroblast growth factor 21 (FGF21) receptor. This study is initiated to evaluate the clinical efficacy of HEC88473 in women with PCOS and to explore its potential as a new therapeutic option for the management of PCOS.

Eligibility criteria

Qualifiers

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.

Polycystic ovarian morphology: at least one ovary with ≥20 antral follicles (diameter <10 mm), confirmed by transvaginal or transrectal pelvic ultrasonography;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • GLP-1/FGF21 dual agonist (HEC88473)

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators