Efficacy of a GLP-1/FGF21 Dual Agonist for Treating PCOS
2026年5月25日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
30
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jingjing JIANG, MD, PhD
- 電話番号：86-021-64041990
- メール：jiang.jingjing@zs-hospital.sh.cn
研究場所
-
-
Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、201508
- 募集
- Zhongshan hospital, Fudan university
-
コンタクト：
- Jingjing JIANG, MD, PhD
- 電話番号：86-021-64041990
- メール：jiang.jingjing@zs-hospital.sh.cn
-
主任研究者：
- Jingjing JIANG, MD, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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:
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).
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Free Androgen Index Over 24 Weeks of Treatment
時間枠：Baseline to Week 24 (assessed at scheduled follow-up visits).
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Longitudinal changes in free androgen index from baseline at each scheduled follow-up visit during the 24-week treatment period.
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Baseline to Week 24 (assessed at scheduled follow-up visits).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in the Number of Spontaneous Menstrual Cycles During the 24-Week Treatment Period Compared With the 24-Week Pre-treatment Period
時間枠：24 weeks before treatment initiation to 24 weeks after treatment initiation.
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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.
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24 weeks before treatment initiation to 24 weeks after treatment initiation.
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Change From Baseline in Bilateral Antral Follicle Count (Diameter <10 mm) at Week 24
時間枠：Baseline to Week 24.
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Change from baseline in the total number of antral follicles with a diameter <10 mm in both ovaries after 24 weeks of treatment.
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Baseline to Week 24.
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Change From Baseline in Bilateral Ovarian Volume at Week 24
時間枠：Baseline to Week 24.
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Change from baseline in the total ovarian volume of both ovaries after 24 weeks of treatment.
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Baseline to Week 24.
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Change From Baseline in Serum AMH at Week 24
時間枠：Baseline to Week 24.
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Change from baseline in serum levels of anti-Müllerian hormone (AMH) after 24 weeks of treatment.
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Baseline to Week 24.
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Change From Baseline in Serum Total Testosterone at Week 24
時間枠：Baseline to Week 24.
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Change from baseline in serum levels of total testosterone after 24 weeks of treatment.
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Baseline to Week 24.
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Change From Baseline in Serum DHEA-S at Week 24
時間枠：Baseline to Week 24.
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Change from baseline in serum levels of dehydroepiandrosterone sulfate (DHEA-S) after 24 weeks of treatment.
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Baseline to Week 24.
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Change From Baseline in Serum SHBG at Week 24
時間枠：Baseline to Week 24.
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Change from baseline in serum levels of sex hormone-binding globulin (SHBG) after 24 weeks of treatment.
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Baseline to Week 24.
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Change From Baseline in HOMA IR Index at Week 24
時間枠：Baseline to Week 24.
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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.
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Baseline to Week 24.
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Change From Baseline in Lipid Profile at Week 24
時間枠：Baseline to Week 24.
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Change from baseline in serum lipid profile after 24 weeks of treatment.
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Baseline to Week 24.
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Change From Baseline in Body Weight at Week 24
時間枠：Baseline to Week 24.
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Change from baseline in body weight after 24 weeks of treatment.
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Baseline to Week 24.
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Change From Baseline in Waist Circumference at Week 24
時間枠：Baseline to Week 24.
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Change from baseline in waist circumference after 24 weeks of treatment.
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Baseline to Week 24.
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Change From Baseline in Quality of Life Assessed by SF-36 at Week 24
時間枠：Baseline to Week 24.
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Change from baseline in quality of life evaluated using the Short Form-36 (SF-36) after 24 weeks of treatment.
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Baseline to Week 24.
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Change From Baseline in Quality of Life Assessed by PCOSQ at Week 24
時間枠：Baseline to Week 24.
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Change from baseline in quality of life evaluated using the Polycystic Ovary Syndrome Questionnaire (PCOSQ) after 24 weeks of treatment.
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Baseline to Week 24.
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Incidence and Severity of Adverse Events During the 24-Week Treatment Period
時間枠：Baseline to Week 24.
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Assessment of the incidence, type, and severity of adverse events occurring during the 24-week treatment period.
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Baseline to Week 24.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2027年12月1日
試験登録日
最初に提出
2026年5月4日
QC基準を満たした最初の提出物
2026年5月25日
最初の投稿 (実際)
2026年5月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月29日
QC基準を満たした最後の更新が送信されました
2026年5月25日
最終確認日
2026年1月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- B2025-709R
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD 共有時間枠
After publication.
IPD 共有アクセス基準
IPD and supporting information will be available to researchers upon reasonable request (e.g., with a practical and meaningful research proposal).
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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