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PCOS (Polycystic Ovary Syndrome)Phase 2NCT07616037

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

A Phase 2 study testing GLP-1/FGF21 dual agonist (HEC88473) in people with PCOS (Polycystic Ovary Syndrome), run by Shanghai Zhongshan Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
PCOS (Polycystic Ovary Syndrome)
What is being tested?
GLP-1/FGF21 dual agonist (HEC88473)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Jun 2026to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jingjing JIANG, MD, PhD contact

86-021-64041990

jiang.jingjing@zs-hospital.sh.cn

China1 site, 1 recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 201508

    Jingjing JIANG, MD, PhD, 86-021-64041990, jiang.jingjing@zs-hospital.sh.cn

    Jingjing JIANG, MD, PhD

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
GLP-1/FGF21 dual agonist (HEC88473)
Keywords
PCOS, GLP-1/FGF21 dual agonist
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLP-1/FGF21 dual agonist (HEC88473)Drug

    GLP-1/FGF21 dual agonist (HEC88473) will be administered by subcutaneous injection once weekly. The starting dose is 15 mg for 3 consecutive weeks. If well tolerated, the dose will be escalated to 30 mg for an additional 3 weeks, followed by further escalation to 45 mg for 18 weeks, provided tolerability is maintained.

Study groups in NCT07616037
Study groupRoleWhat they receive
HEC88473 Treatment in Women With PCOSExperimentalTo evaluate the longitudinal changes in androgen metabolism in women with polycystic ovary syndrome (PCOS) during treatment with the GLP-1/FGF21 dual agonist HEC88473.
Receives: Drug: GLP-1/FGF21 dual agonist (HEC88473)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Free Androgen Index Over 24 Weeks of Treatment

    Longitudinal changes in free androgen index from baseline at each scheduled follow-up visit during the 24-week treatment period.

    Measured: Baseline to Week 24 (assessed at scheduled follow-up visits).

Secondary outcomes (14)

  1. Change in the Number of Spontaneous Menstrual Cycles During the 24-Week Treatment Period Compared With the 24-Week Pre-treatment Period

    Comparison of the number of spontaneous menstrual cycles during the 24-week intervention period with those during the 24-week period prior to treatment initiation.

    Measured: 24 weeks before treatment initiation to 24 weeks after treatment initiation.

  2. Change From Baseline in Bilateral Antral Follicle Count (Diameter <10 mm) at Week 24

    Change from baseline in the total number of antral follicles with a diameter <10 mm in both ovaries after 24 weeks of treatment.

    Measured: Baseline to Week 24.

  3. Change From Baseline in Bilateral Ovarian Volume at Week 24

    Change from baseline in the total ovarian volume of both ovaries after 24 weeks of treatment.

    Measured: Baseline to Week 24.

  4. Change From Baseline in Serum AMH at Week 24

    Change from baseline in serum levels of anti-Müllerian hormone (AMH) after 24 weeks of treatment.

    Measured: Baseline to Week 24.

  5. Change From Baseline in Serum Total Testosterone at Week 24

    Change from baseline in serum levels of total testosterone after 24 weeks of treatment.

    Measured: Baseline to Week 24.

  6. Change From Baseline in Serum DHEA-S at Week 24

    Change from baseline in serum levels of dehydroepiandrosterone sulfate (DHEA-S) after 24 weeks of treatment.

    Measured: Baseline to Week 24.

  7. Change From Baseline in Serum SHBG at Week 24

    Change from baseline in serum levels of sex hormone-binding globulin (SHBG) after 24 weeks of treatment.

    Measured: Baseline to Week 24.

  8. Change From Baseline in HOMA IR Index at Week 24

    Change from baseline in insulin resistance assessed by the HOMA Insulin Resistance index (calculated from fasting plasma glucose in mmol/L × fasting serum insulin in μU/mL/22.5) after 24 weeks of treatment.

    Measured: Baseline to Week 24.

  9. Change From Baseline in Lipid Profile at Week 24

    Change from baseline in serum lipid profile after 24 weeks of treatment.

    Measured: Baseline to Week 24.

  10. Change From Baseline in Body Weight at Week 24

    Change from baseline in body weight after 24 weeks of treatment.

    Measured: Baseline to Week 24.

  11. Change From Baseline in Waist Circumference at Week 24

    Change from baseline in waist circumference after 24 weeks of treatment.

    Measured: Baseline to Week 24.

  12. Change From Baseline in Quality of Life Assessed by SF-36 at Week 24

    Change from baseline in quality of life evaluated using the Short Form-36 (SF-36) after 24 weeks of treatment.

    Measured: Baseline to Week 24.

  13. Change From Baseline in Quality of Life Assessed by PCOSQ at Week 24

    Change from baseline in quality of life evaluated using the Polycystic Ovary Syndrome Questionnaire (PCOSQ) after 24 weeks of treatment.

    Measured: Baseline to Week 24.

  14. Incidence and Severity of Adverse Events During the 24-Week Treatment Period

    Assessment of the incidence, type, and severity of adverse events occurring during the 24-week treatment period.

    Measured: Baseline to Week 24.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
GLP-1/FGF21 dual agonist (HEC88473) will be administered by subcutaneous injection once weekly. The starting dose is 15 mg for 3 consecutive weeks. If well tolerated, the dose will be escalated to 30 mg for an additional 3 weeks, followed by further escalation to 45 mg for 18 weeks, provided tolerability is maintained.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07616037
Sponsor's protocol ID
B2025-709R
Status last verified
Jan 2026
First submitted
4 May 2026
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GLP-1/FGF21 dual agonist (HEC88473) in people with PCOS (Polycystic Ovary Syndrome), run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jingjing JIANG, MD, PhD (86-021-64041990, jiang.jingjing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Free Androgen Index Over 24 Weeks of Treatment (time frame: Baseline to Week 24 (assessed at scheduled follow-up visits).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07616037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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