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Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents

2026年7月29日 更新者：Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

A Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of Efsubaglutide Alfa in Chinese Adolescents With Obesity

This is a Phase Ib, randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Efsubaglutide Alfa Injection following multiple-dose administration in Chinese adolescent participants with obesity.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

The prevalence of obesity in adolescents is rising and threatening physiological and psychological health. Different from adults with obesity, there is still no approved drug to manage the obesity in adolescents, In order to provide the therapeutical option earlier, the weight-reduction study in obese adolescents is planned. The primary objective of this Phase Ib study is to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of multiple doses of Efsubaglutide Alfa at different dose levels in Chinese adolescent participants with obesity. The secondary objectives include the evaluations of the pharmacodynamic (PD) effects, PK-PD relationship , and immunogenicity of multiple doses of Efsubaglutide Alfa at different dose levels. This randomized, double-blind, placebo-controlled, parallel-group study will enroll a total of 36 adolescent participants aged 12 to 17 years with obesity . 36 participants will be randomized in a 3:1 ratio to receive Efsubaglutide Alfa or placebo administered subcutaneously once weekly (QW) for up to 12 weeks. Safety will be monitored throughout the study by assessment of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESI), laboratory parameters, vital signs, and 12-lead electrocardiograms.

研究の種類

介入

入学 (推定)

36

段階

  • フェーズ 1

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

研究場所

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国
        • 募集
        • Beijing Chaoyang Hospital, Capital Medical University
        • コンタクト：
          • Guang Wang
    • Hubei
      • Wuhan、Hubei、中国
        • まだ募集していません
        • Wuhan Central Hospital
        • コンタクト：
          • Weihua Wang
        • コンタクト：
          • Zhongjing Wang
    • Liaoning
      • Shenyang、Liaoning、中国
        • まだ募集していません
        • Shengjing Hospital, China Medical University
        • コンタクト：
          • Xiaoguang Shi
    • Shandong
      • Jinan、Shandong、中国
        • まだ募集していません
        • Qilu Hospital, Shandong University
        • コンタクト：
          • Xinguo Hou
        • コンタクト：
          • Shuwen Yu
      • Jinan、Shandong、中国
        • 募集
        • Qilu Second Hospital, Shandong University
        • コンタクト：
          • Shuang Liang
        • コンタクト：
          • Deqing Sun

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

  • 子

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • 1. Informed consent must be obtained from the participant's parent or legally authorized representative and assent from the adolescent participant before any study-related procedures.
  • 2. Adolescent participants aged ≥12 years and <18 years (at the time of informed consent).
  • 3. At screening, meet the obesity criteria defined in "WS/T586-2018 Screening for Overweight and Obesity among School-age Children and Adolescents".
  • 4. Before screening, have been on dietary and exercise control alone for at least 3 months with <5.0% reduction in body mass index (based on self-report or report by parent or legally authorized representative).
  • 5.Must be willing to follow the diet and exercise guidance and able to maintain such stable diet and exercise lifestyle during the study period.
  • 6. Female participants of childbearing potential must have a negative serum pregnancy test at screening.
  • 7. Able to understand all study procedures, willing to strictly comply with the study protocol, complete the study visits as scheduled, and finish the study.

Exclusion Criteria:

  • 1. Pre-pubertal participants (Tanner Stage I).
  • 2. History of severe allergic reactions or suspected allergy to study drug or its ingredients.
  • 3. Pregnant or lactating women; men or women of childbearing potential planning pregnancy or unwilling to use highly effective contraception throughout the study.
  • 4. Use of weight-affecting medications before screening.
  • 5. Known monogenic obesity, obesity caused by other diseases or medications,
  • 6. Previously diagnosed Type 1 diabetes, Type 2 diabetes, or special types of diabetes;
  • 7. history of severe hypoglycemia or recurrent symptomatic hypoglycemia (≥2 times within half a year).
  • 8. Clinically significant gastric emptying abnormalities, severe chronic gastrointestinal diseases, long-term use of medications directly affecting gastrointestinal motility, or gastrointestinal surgery within 6 months prior to screening, deemed unsuitable for the study by the investigator.
  • 9. History of malignancy within 5 years prior to screening, excluding clinically cured cervical intraepithelial neoplasia, squamous cell carcinoma, or basal cell carcinoma within 5 years.
  • 10. Major surgery within 6 months prior to screening, or planned surgery during the study that may affect study completion or compliance;
  • 11. history of bariatric surgery or planned bariatric surgery during the study (e.g., gastric bypass, gastric banding).
  • 12. History of acute or chronic pancreatitis, symptomatic gallbladder disease at screening, history of pancreatic injury, or other high-risk factors for pancreatitis; or amylase or lipase >2.0×ULN at screening.
  • 13. Known or suspected drug/substance abuse at screening; positive HBsAg;
  • 14. Positive HCV antibody with HCV RNA above the lower limit of detection; positive HIV antibody; positive Tp-Ab.
  • 15. Currently receiving or received chronic (>14 days) systemic glucocorticoid therapy within 3 months prior to screening, or evidence of severe active autoimmune disease that may require systemic glucocorticoid therapy within the next 12 months as judged by the investigator.
  • 16. History of hyperthyroidism or hypothyroidism, or TSH <1.0×LLN, or TSH >1.5×ULN, or history of medullary thyroid carcinoma.
  • 17. Serum calcitonin ≥50 ng/L (pg/mL) at screening; ALT >3.0×ULN, or AST >3.0×ULN, or total bilirubin >2.0×ULN; eGFR <60 mL/min/1.73 m² at screening; fasting triglycerides ≥5.64 mmol/L (500 mg/dL).
  • 18. Blood donation and/or blood loss ≥400 mL or bone marrow donation within 3 months prior to screening, or presence of hemoglobinopathy, hemolytic anemia, sickle cell anemia, or hemoglobin <118 g/L (ages 12-<13 years), <129 g/L (males ≥13 years), or <114 g/L (females ≥13 years).
  • 19. Participation in vaccine or medical device clinical trials within 3 months prior to screening, or any drug clinical trial within less than 3 months or 5 half-lives (whichever is longer).
  • 20. History of moderate to severe depression, anxiety disorder, or severe psychiatric illness.
  • 21. Any other condition that, in the opinion of the investigator, may affect the participant's safety or compliance with the study protocol.

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：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Efsubaglutide Alfa 5 mg QW
Efsubaglutide Alfa, 5 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
薬：Efsubaglutide Alfa 5 mg QW
Efsubaglutide Alfa Injection Subcutaneous injection
実験的：Efsubaglutide Alfa 10 mg QW
Efsubaglutide Alfa, 10 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
薬：Efsubaglutide Alfa 10 mg QW
Efsubaglutide Alfa Injection Subcutaneous injection
実験的：Efsubaglutide Alfa 20 mg QW
Efsubaglutide Alfa, 20 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
薬：Efsubaglutide Alfa 20 mg QW
Efsubaglutide Alfa Injection Subcutaneous injection
プラセボコンパレーター：Efsubaglutide Alfa placebo
Efsubaglutide Alfa placebo, once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
薬：Efsubaglutide Alfa placebo
Efsubaglutide Alfa placebo Injection Subcutaneous injection

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
Safety and tolerability: incidence of TEAEs, SAEs, and AESI
時間枠：Throughout the study (up to Week 18)
Safety and tolerability assessed by monitoring treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESI) throughout the study
Throughout the study (up to Week 18)
Pharmacokinetic (PK) characteristics at steady state following multiple doses
時間枠：Throughout the study (up to Week 18)
PK parameters including plasma drug concentrations at steady state following multiple-dose administration of Efsubaglutide Alfa
Throughout the study (up to Week 18)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in body mass index (BMI) from baseline (absolute and percentage)
時間枠：Week 12
Change in BMI from baseline at Week 12, measured as absolute value and percentage change
Week 12
Change in BMI from baseline over time (absolute and percentage)
時間枠：Weeks 4, 8, and 12
Change in BMI from baseline at Weeks 4, 8, and 12, measured as absolute value and percentage change
Weeks 4, 8, and 12
Change in fasting body weight from baseline (absolute and percentage)
時間枠：Week 12
Change in fasting body weight from baseline at Week 12, measured as absolute value and percentage change
Week 12
Change in fasting body weight from baseline over time (absolute and percentage)
時間枠：Weeks 4, 8, and 12
Change in fasting body weight from baseline at Weeks 4, 8, and 12, measured as absolute value and percentage change
Weeks 4, 8, and 12
Change in waist circumference from baseline
時間枠：Week 12
Change in waist circumference from baseline at Week 12
Week 12
Change in hip circumference from baseline
時間枠：Week 12
Change in hip circumference from baseline at Week 12
Week 12
Change in waist-to-hip ratio (WHR) from baseline
時間枠：Week 12
Change in waist-to-hip ratio (WHR) from baseline at Week 12
Week 12
Change in waist-to-height ratio from baseline
時間枠：Week 12
Change in waist-to-height ratio from baseline at Week 12
Week 12
Proportion of participants achieving ≥5%, ≥10%, and ≥15% reduction in BMI and/or fasting body weight from baseline
時間枠：Week 12
Week 12
Change in systolic blood pressure and diastolic blood pressure from baseline
時間枠：Week 12
Week 12
Change in lipid levels(TC、HDL-C、LDL-C、TG) from baseline
時間枠：Week 12
Week 12
Change in fasting blood glucose from baseline
時間枠：Week 12
Week 12
Change in HbA1c from baseline
時間枠：Week 12
Week 12
Change in fasting insulin from baseline
時間枠：Week 12
Week 12
Change in blood uric acid from baseline
時間枠：Week 12
Week 12
The correlation between Efsubaglutide Alfa Cmax, ss and BMI
時間枠：Throughout the study (up to Week 18)
Throughout the study (up to Week 18)
The correlation between Efsubaglutide Alfa AUC0-168h, ss and BMI
時間枠：Throughout the study (up to Week 18)
Throughout the study (up to Week 18)
Incidence, titer, and persistence of anti-drug antibodies (ADA)
時間枠：Throughout the study (up to Week 18)
Throughout the study (up to Week 18)
Incidence, titer, and persistence of neutralizing antibodies
時間枠：Throughout the study (up to Week 18)
Throughout the study (up to Week 18)

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。

スポンサー

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

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 (実際)

2026年7月16日

一次修了 (推定)

2027年4月30日

研究の完了 (推定)

2027年8月31日

試験登録日

最初に提出

2026年6月29日

QC基準を満たした最初の提出物

2026年7月3日

最初の投稿 (実際)

2026年7月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月30日

QC基準を満たした最後の更新が送信されました

2026年7月29日

最終確認日

2026年7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

  • YN012Y-Ib-W102

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?

いいえ

医薬品およびデバイス情報、研究文書

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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