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

25 mei 2026 bijgewerkt door: Shanghai Zhongshan Hospital

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201508
        • Werving
        • Zhongshan hospital, Fudan university
        • Contact:
        • Hoofdonderzoeker:
          • Jingjing JIANG, MD, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: HEC88473 Treatment in Women With PCOS
To evaluate the longitudinal changes in androgen metabolism in women with polycystic ovary syndrome (PCOS) during treatment with the GLP-1/FGF21 dual agonist HEC88473.
Geneesmiddel: GLP-1/FGF21 dual agonist (HEC88473)
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Free Androgen Index Over 24 Weeks of Treatment
Tijdsspanne: Baseline to Week 24 (assessed at scheduled follow-up visits).
Longitudinal changes in free androgen index from baseline at each scheduled follow-up visit during the 24-week treatment period.
Baseline to Week 24 (assessed at scheduled follow-up visits).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in the Number of Spontaneous Menstrual Cycles During the 24-Week Treatment Period Compared With the 24-Week Pre-treatment Period
Tijdsspanne: 24 weeks before treatment initiation to 24 weeks after treatment initiation.
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.
24 weeks before treatment initiation to 24 weeks after treatment initiation.
Change From Baseline in Bilateral Antral Follicle Count (Diameter <10 mm) at Week 24
Tijdsspanne: Baseline to 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.
Baseline to Week 24.
Change From Baseline in Bilateral Ovarian Volume at Week 24
Tijdsspanne: Baseline to Week 24.
Change from baseline in the total ovarian volume of both ovaries after 24 weeks of treatment.
Baseline to Week 24.
Change From Baseline in Serum AMH at Week 24
Tijdsspanne: Baseline to Week 24.
Change from baseline in serum levels of anti-Müllerian hormone (AMH) after 24 weeks of treatment.
Baseline to Week 24.
Change From Baseline in Serum Total Testosterone at Week 24
Tijdsspanne: Baseline to Week 24.
Change from baseline in serum levels of total testosterone after 24 weeks of treatment.
Baseline to Week 24.
Change From Baseline in Serum DHEA-S at Week 24
Tijdsspanne: Baseline to Week 24.
Change from baseline in serum levels of dehydroepiandrosterone sulfate (DHEA-S) after 24 weeks of treatment.
Baseline to Week 24.
Change From Baseline in Serum SHBG at Week 24
Tijdsspanne: Baseline to Week 24.
Change from baseline in serum levels of sex hormone-binding globulin (SHBG) after 24 weeks of treatment.
Baseline to Week 24.
Change From Baseline in HOMA IR Index at Week 24
Tijdsspanne: Baseline to 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.
Baseline to Week 24.
Change From Baseline in Lipid Profile at Week 24
Tijdsspanne: Baseline to Week 24.
Change from baseline in serum lipid profile after 24 weeks of treatment.
Baseline to Week 24.
Change From Baseline in Body Weight at Week 24
Tijdsspanne: Baseline to Week 24.
Change from baseline in body weight after 24 weeks of treatment.
Baseline to Week 24.
Change From Baseline in Waist Circumference at Week 24
Tijdsspanne: Baseline to Week 24.
Change from baseline in waist circumference after 24 weeks of treatment.
Baseline to Week 24.
Change From Baseline in Quality of Life Assessed by SF-36 at Week 24
Tijdsspanne: Baseline to Week 24.
Change from baseline in quality of life evaluated using the Short Form-36 (SF-36) after 24 weeks of treatment.
Baseline to Week 24.
Change From Baseline in Quality of Life Assessed by PCOSQ at Week 24
Tijdsspanne: Baseline to Week 24.
Change from baseline in quality of life evaluated using the Polycystic Ovary Syndrome Questionnaire (PCOSQ) after 24 weeks of treatment.
Baseline to Week 24.
Incidence and Severity of Adverse Events During the 24-Week Treatment Period
Tijdsspanne: Baseline to Week 24.
Assessment of the incidence, type, and severity of adverse events occurring during the 24-week treatment period.
Baseline to Week 24.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shanghai Zhongshan Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

4 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

25 mei 2026

Laatst geverifieerd

1 januari 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • B2025-709R

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

IPD-tijdsbestek voor delen

After publication.

IPD-toegangscriteria voor delen

IPD and supporting information will be available to researchers upon reasonable request (e.g., with a practical and meaningful research proposal).

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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