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Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents

29. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

36

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Efsubaglutide Alfa 5 mg QW
Efsubaglutide Alfa, 5 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
Medicin: Efsubaglutide Alfa 5 mg QW
Efsubaglutide Alfa Injection Subcutaneous injection
Eksperimentel: Efsubaglutide Alfa 10 mg QW
Efsubaglutide Alfa, 10 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
Medicin: Efsubaglutide Alfa 10 mg QW
Efsubaglutide Alfa Injection Subcutaneous injection
Eksperimentel: Efsubaglutide Alfa 20 mg QW
Efsubaglutide Alfa, 20 mg once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
Medicin: Efsubaglutide Alfa 20 mg QW
Efsubaglutide Alfa Injection Subcutaneous injection
Placebo komparator: Efsubaglutide Alfa placebo
Efsubaglutide Alfa placebo, once weekly，12 weeks Solution for injection in pre-filled auto-injector pen
Medicin: Efsubaglutide Alfa placebo
Efsubaglutide Alfa placebo Injection Subcutaneous injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety and tolerability: incidence of TEAEs, SAEs, and AESI
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. juli 2026

Primær færdiggørelse (Anslået)

30. april 2027

Studieafslutning (Anslået)

31. august 2027

Datoer for studieregistrering

Først indsendt

29. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • YN012Y-Ib-W102

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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