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Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents

29 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

36

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Porcelana
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana
        • Reclutamiento
        • Beijing Chaoyang Hospital, Capital Medical University
        • Contacto:
          • Guang Wang
    • Hubei
      • Wuhan, Hubei, Porcelana
        • Aún no reclutando
        • Wuhan Central Hospital
        • Contacto:
          • Weihua Wang
        • Contacto:
          • Zhongjing Wang
    • Liaoning
      • Shenyang, Liaoning, Porcelana
        • Aún no reclutando
        • Shengjing Hospital, China Medical University
        • Contacto:
          • Xiaoguang Shi
    • Shandong
      • Jinan, Shandong, Porcelana
        • Aún no reclutando
        • Qilu Hospital, Shandong University
        • Contacto:
          • Xinguo Hou
        • Contacto:
          • Shuwen Yu
      • Jinan, Shandong, Porcelana
        • Reclutamiento
        • Qilu Second Hospital, Shandong University
        • Contacto:
          • Shuang Liang
        • Contacto:
          • Deqing Sun

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Efsubaglutide Alfa 5 mg QW
Efsubaglutide Alfa, 5 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
Droga: Efsubaglutide Alfa 5 mg QW
Efsubaglutide Alfa Injection Subcutaneous injection
Experimental: Efsubaglutide Alfa 10 mg QW
Efsubaglutide Alfa, 10 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
Droga: Efsubaglutide Alfa 10 mg QW
Efsubaglutide Alfa Injection Subcutaneous injection
Experimental: Efsubaglutide Alfa 20 mg QW
Efsubaglutide Alfa, 20 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
Droga: Efsubaglutide Alfa 20 mg QW
Efsubaglutide Alfa Injection Subcutaneous injection
Comparador de placebos: Efsubaglutide Alfa placebo
Efsubaglutide Alfa placebo, once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
Droga: Efsubaglutide Alfa placebo
Efsubaglutide Alfa placebo Injection Subcutaneous injection

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Safety and tolerability: incidence of TEAEs, SAEs, and AESI
Periodo de tiempo: 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
Periodo de tiempo: 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)

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de julio de 2026

Finalización primaria (Estimado)

30 de abril de 2027

Finalización del estudio (Estimado)

31 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

29 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de julio de 2026

Publicado por primera vez (Actual)

9 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • YN012Y-Ib-W102

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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