RecruitingAdolescence Obesity
Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents
Eligible age
12–17 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Source: ClinicalTrials.gov · NCT07693426 · last updated 2026-07-30