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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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

36

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国
        • 招聘中
        • Beijing Chaoyang Hospital, Capital Medical University
        • 接触：
          • Guang Wang
    • Hubei
      • Wuhan、Hubei、中国
        • 尚未招聘
        • Wuhan Central Hospital
        • 接触：
          • Weihua Wang
        • 接触：
          • Zhongjing Wang
    • Liaoning
      • Shenyang、Liaoning、中国
        • 尚未招聘
        • Shengjing Hospital, China Medical University
        • 接触：
          • Xiaoguang Shi
    • Shandong
      • Jinan、Shandong、中国
        • 尚未招聘
        • Qilu Hospital, Shandong University
        • 接触：
          • Xinguo Hou
        • 接触：
          • Shuwen Yu
      • Jinan、Shandong、中国
        • 招聘中
        • Qilu Second Hospital, Shandong University
        • 接触：
          • Shuang Liang
        • 接触：
          • Deqing Sun

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Efsubaglutide Alfa 5 mg QW
Efsubaglutide Alfa, 5 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
药品：Efsubaglutide Alfa 5 mg QW
Efsubaglutide Alfa Injection Subcutaneous injection
实验性的：Efsubaglutide Alfa 10 mg QW
Efsubaglutide Alfa, 10 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
药品：Efsubaglutide Alfa 10 mg QW
Efsubaglutide Alfa Injection Subcutaneous injection
实验性的：Efsubaglutide Alfa 20 mg QW
Efsubaglutide Alfa, 20 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
药品：Efsubaglutide Alfa 20 mg QW
Efsubaglutide Alfa Injection Subcutaneous injection
安慰剂比较：Efsubaglutide Alfa placebo
Efsubaglutide Alfa placebo, once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
药品：Efsubaglutide Alfa placebo
Efsubaglutide Alfa placebo Injection Subcutaneous injection

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Safety and tolerability: incidence of TEAEs, SAEs, and AESI
大体时间：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
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
Change in body mass index (BMI) from baseline (absolute and percentage)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：Week 12
Change in waist circumference from baseline at Week 12
Week 12
Change in hip circumference from baseline
大体时间：Week 12
Change in hip circumference from baseline at Week 12
Week 12
Change in waist-to-hip ratio (WHR) from baseline
大体时间：Week 12
Change in waist-to-hip ratio (WHR) from baseline at Week 12
Week 12
Change in waist-to-height ratio from baseline
大体时间：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
大体时间：Week 12
Week 12
Change in systolic blood pressure and diastolic blood pressure from baseline
大体时间：Week 12
Week 12
Change in lipid levels(TC、HDL-C、LDL-C、TG) from baseline
大体时间：Week 12
Week 12
Change in fasting blood glucose from baseline
大体时间：Week 12
Week 12
Change in HbA1c from baseline
大体时间：Week 12
Week 12
Change in fasting insulin from baseline
大体时间：Week 12
Week 12
Change in blood uric acid from baseline
大体时间：Week 12
Week 12
The correlation between Efsubaglutide Alfa Cmax, ss and BMI
大体时间：Throughout the study (up to Week 18)
Throughout the study (up to Week 18)
The correlation between Efsubaglutide Alfa AUC0-168h, ss and BMI
大体时间：Throughout the study (up to Week 18)
Throughout the study (up to Week 18)
Incidence, titer, and persistence of anti-drug antibodies (ADA)
大体时间：Throughout the study (up to Week 18)
Throughout the study (up to Week 18)
Incidence, titer, and persistence of neutralizing antibodies
大体时间：Throughout the study (up to Week 18)
Throughout the study (up to Week 18)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月16日

初级完成 (估计的)

2027年4月30日

研究完成 (估计的)

2027年8月31日

研究注册日期

首次提交

2026年6月29日

首先提交符合 QC 标准的

2026年7月3日

首次发布 (实际的)

2026年7月9日

研究记录更新

最后更新发布 (实际的)

2026年7月30日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • YN012Y-Ib-W102

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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