Tests a new GLP-1 and FGF21 drug for polycystic ovary syndrome
Tests a long-acting GLP-1 and FGF21 drug in women with polycystic ovary syndrome.
Plain-language title generated from the registry record
Registry title: Efficacy of a GLP-1/FGF21 Dual Agonist for Treating PCOS
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 40 with polycystic ovary syndrome (PCOS) to test a new drug, HEC88473.
- Age
- 18 to 40 years
- Sex
- Women only
- Disease stage
- PCOS with at least two of three signs: irregular periods, polycystic ovaries on ultrasound (at least 20 small follicles in one ovary), or high male hormones (total testosterone >1.67 nmol/L or modified Ferriman-Gallwey score >4).
- Earlier treatment
- Cannot have used hormonal contraceptives within 2 months, GLP-1 receptor agonists within 12 months, or bariatric surgery within 12 months. Some other drugs must be stopped 1 to 2 months before screening.
Main reasons for not taking part
- Pregnant or breastfeeding, or planning pregnancy until 2 months after the last dose
- Type 1 or type 2 diabetes
- History of pancreatitis, or personal or family history of medullary thyroid cancer or MEN 2A/2B
- Other hormone disorders that can cause polycystic ovaries (for example Cushing's syndrome)
- Serious heart, liver or kidney disease, or any cancer
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 40 years old?
Source: NCT07616037, who can take part
Where in China
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaContact: Jingjing JIANG, MD, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Zhongshan Hospital
- Trial code
- NCT07616037
- Record updated
- 29 May 2026
- Original description
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.Read full original descriptionShow less
A Preliminary Study to Explore the Efficacy of a GLP-1/FGF21 Dual Agonist (HEC88473) in Patients With Polycystic Ovary Syndrome (PCOS)
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.
Inclusion: 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:; 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; Polycystic ovarian morphology: at least one ovary with ≥20 antral follicles (diameter <10 mm), confirmed by transvaginal or transrectal pelvic ultrasonography; Hyperandrogenism: biochemical hyperandrogenism (total testosterone >1.67 nmol/L) or clinical hyperandrogenism (modified Ferriman-Gallwey [mFG] score >4).
Exclusion: Use of hormonal contraceptives within 2 months prior to screening; 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; Treatment with GLP-1 receptor agonists within the past 12 months; 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; History of bariatric surgery within the past 12 months; 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; Pregnancy or lactation.