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Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents
Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents
RecruitingPhase 1
Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Conditions: Adolescence Obesity
Interventions: Efsubaglutide Alfa 5 mg QW, Efsubaglutide Alfa 10 mg QW, Efsubaglutide Alfa 20 mg QW, Efsubaglutide Alfa placebo
Countries: China
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.
Eligibility overview
Sex: ALL
Age: 12 Years to 17 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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.
Locations (5)
- Beijing, Beijing Municipality, China
- Wuhan, Hubei, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Jinan, Shandong, China