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

25. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 201508
        • Rekruttering
        • Zhongshan Hospital, Fudan University
        • Kontakt:
        • Ledende efterforsker:
          • Jingjing JIANG, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Free Androgen Index Over 24 Weeks of Treatment
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the Number of Spontaneous Menstrual Cycles During the 24-Week Treatment Period Compared With the 24-Week Pre-treatment Period
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai Zhongshan Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

25. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B2025-709R

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-delingstidsramme

After publication.

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med PCOS (polycystisk ovariesyndrom)

Kliniske forsøg med GLP-1/FGF21 dual agonist (HEC88473)

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Betingelser

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