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Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents

3 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

36

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina
        • Beijing Chaoyang Hospital, Capital Medical University
        • Contatto:
          • Guang Wang
    • Hubei
      • Wuhan, Hubei, Cina
        • Wuhan Central Hospital
        • Contatto:
          • Weihua Wang
        • Contatto:
          • Zhongjing Wang
    • Liaoning
      • Shenyang, Liaoning, Cina
        • Shengjing Hospital, China Medical University
        • Contatto:
          • Xiaoguang Shi
    • Shandong
      • Jinan, Shandong, Cina
        • Qilu Hospital, Shandong University
        • Contatto:
          • Xinguo Hou
        • Contatto:
          • Shuwen Yu
      • Jinan, Shandong, Cina
        • Qilu Second Hospital, Shandong University
        • Contatto:
          • Shuang Liang
        • Contatto:
          • Deqing Sun

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Sperimentale: 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
Sperimentale: 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
Comparatore placebo: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety and tolerability: incidence of TEAEs, SAEs, and AESI
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

10 luglio 2026

Completamento primario (Stimato)

30 aprile 2027

Completamento dello studio (Stimato)

31 agosto 2027

Date di iscrizione allo studio

Primo inviato

29 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • YN012Y-Ib-W102

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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