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

25 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 201508
        • Reclutamento
        • Zhongshan Hospital, Fudan University
        • Contatto:
        • Investigatore principale:
          • Jingjing JIANG, MD, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Free Androgen Index Over 24 Weeks of Treatment
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in the Number of Spontaneous Menstrual Cycles During the 24-Week Treatment Period Compared With the 24-Week Pre-treatment Period
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shanghai Zhongshan Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

4 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 maggio 2026

Primo Inserito (Effettivo)

29 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 maggio 2026

Ultimo verificato

1 gennaio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • B2025-709R

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Periodo di condivisione IPD

After publication.

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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