Efsubaglutide Alfa injections in teenagers living with obesity

Trial details

Who runs it

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Trial code

NCT07693426

Record updated

30 July 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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: 4. Use of weight-affecting medications before screening; 6. Previously diagnosed Type 1 diabetes, Type 2 diabetes, or special types of diabetes; 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; 10. Major surgery within 6 months prior to screening, or planned surgery during the study that may affect study completion or compliance; 13. Known or suspected drug/substance abuse at screening; positive HBsAg; 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; 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); 2. History of severe allergic reactions or suspected allergy to study drug or its ingredients; 5. Known monogenic obesity, obesity caused by other diseases or medications,; 7. history of severe hypoglycemia or recurrent symptomatic hypoglycemia (≥2 times within half a year); 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; 11. history of bariatric surgery or planned bariatric surgery during the study (e.g., gastric bypass, gastric banding); 14. Positive HCV antibody with HCV RNA above the lower limit of detection; positive HIV antibody; positive Tp-Ab; 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; 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; 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); 1. Pre-pubertal participants (Tanner Stage I); 3. Pregnant or lactating women; men or women of childbearing potential planning pregnancy or unwilling to use highly effective contraception throughout the study.

ClinicalTrials.gov NCT07693426