Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents
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
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Phase 1
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: QINGHUA WANG, M.D,Ph.D
- Telefonnummer: +862168788225
- E-Mail: dr.qwang@innogenpharm.com
Studienorte
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China
- Rekrutierung
- Beijing Chaoyang Hospital, Capital Medical University
-
Kontakt:
- Guang Wang
-
-
Hubei
-
Wuhan, Hubei, China
- Noch keine Rekrutierung
- Wuhan Central Hospital
-
Kontakt:
- Weihua Wang
-
Kontakt:
- Zhongjing Wang
-
-
Liaoning
-
Shenyang, Liaoning, China
- Noch keine Rekrutierung
- Shengjing Hospital, China Medical University
-
Kontakt:
- Xiaoguang Shi
-
-
Shandong
-
Jinan, Shandong, China
- Noch keine Rekrutierung
- Qilu Hospital, Shandong University
-
Kontakt:
- Xinguo Hou
-
Kontakt:
- Shuwen Yu
-
Jinan, Shandong, China
- Rekrutierung
- Qilu Second Hospital, Shandong University
-
Kontakt:
- Shuang Liang
-
Kontakt:
- Deqing Sun
-
-
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Experimental: Efsubaglutide Alfa 5 mg QW
Efsubaglutide Alfa, 5 mg once weekly,12 weeks Solution for injection in pre-filled auto-injector pen
|
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
|
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
|
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
|
Efsubaglutide Alfa placebo Injection Subcutaneous injection
|
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Safety and tolerability: incidence of TEAEs, SAEs, and AESI
Zeitfenster: 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
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in body mass index (BMI) from baseline (absolute and percentage)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Week 12
|
Change in waist circumference from baseline at Week 12
|
Week 12
|
|
Change in hip circumference from baseline
Zeitfenster: Week 12
|
Change in hip circumference from baseline at Week 12
|
Week 12
|
|
Change in waist-to-hip ratio (WHR) from baseline
Zeitfenster: Week 12
|
Change in waist-to-hip ratio (WHR) from baseline at Week 12
|
Week 12
|
|
Change in waist-to-height ratio from baseline
Zeitfenster: 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
Zeitfenster: Week 12
|
Week 12
|
|
|
Change in systolic blood pressure and diastolic blood pressure from baseline
Zeitfenster: Week 12
|
Week 12
|
|
|
Change in lipid levels(TC、HDL-C、LDL-C、TG) from baseline
Zeitfenster: Week 12
|
Week 12
|
|
|
Change in fasting blood glucose from baseline
Zeitfenster: Week 12
|
Week 12
|
|
|
Change in HbA1c from baseline
Zeitfenster: Week 12
|
Week 12
|
|
|
Change in fasting insulin from baseline
Zeitfenster: Week 12
|
Week 12
|
|
|
Change in blood uric acid from baseline
Zeitfenster: Week 12
|
Week 12
|
|
|
The correlation between Efsubaglutide Alfa Cmax, ss and BMI
Zeitfenster: Throughout the study (up to Week 18)
|
Throughout the study (up to Week 18)
|
|
|
The correlation between Efsubaglutide Alfa AUC0-168h, ss and BMI
Zeitfenster: Throughout the study (up to Week 18)
|
Throughout the study (up to Week 18)
|
|
|
Incidence, titer, and persistence of anti-drug antibodies (ADA)
Zeitfenster: Throughout the study (up to Week 18)
|
Throughout the study (up to Week 18)
|
|
|
Incidence, titer, and persistence of neutralizing antibodies
Zeitfenster: Throughout the study (up to Week 18)
|
Throughout the study (up to Week 18)
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- YN012Y-Ib-W102
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .