Glp-1/FGF21 dual agonist for PCOS treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial evaluating HEC88473, a novel long-acting dual agonist of GLP-1 and FGF21, in women with polycystic ovary syndrome (PCOS). Eligible participants are 18 to 40 years old, not planning pregnancy for the study duration, and must meet at least two PCOS diagnostic criteria. The study will assess safety and potential benefits on metabolic and reproductive endpoints, including weight, androgen levels, and menstrual regularity. Participants will receive the study drug with ongoing monitoring and contraceptive guidance as required. The trial is led by Shanghai Zhongshan Hospital, with sites at Fudan University in Shanghai, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jingjing JIANG, MD, PhD
• Email: jiang.jingjing@zs-hospital.sh.cn
• Phone: 86-021-64041990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.