Clinical trial Recruiting at 2 sites Phase 1 Interventional Ages 12 to 17

Efsubaglutide Alfa Injection in Obese Adolescents

Official title: 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

Run by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. · NCT07693426 · Data updated 2026-11-12

This study tests whether Efsubaglutide Alfa can be safe and help with weight loss in adolescents aged 12 to 17 who are living with obesity.

Quick facts

PhasePhase 1
Study typeInterventional
Ages12 Years to 17 Years
SexAll
Enrollment36 (estimated)
SponsorShanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Academic / other
Locations5 sites (Beijing, Beijing Municipality and 4 other locations)
StatusRecruiting
StartedJuly 16, 2026
Main results expectedApril 30, 2027
Study endsAugust 31, 2027
Registry record updatedJuly 30, 2026
Trial IDNCT07693426 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adolescents aged 12 to 17 with obesity who have not achieved sufficient BMI reduction after 3 months of diet and exercise alone and whose guardians consent.

Probably not a fit

Participants who do not respond to treatment or who experience tolerability issues may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase Ib, randomized, double-blind, placebo-controlled study in Chinese adolescents with obesity to assess safety, tolerability, and how the drug behaves in the body (PK/PD) after multiple weekly injections. Participants are assigned to Efsubaglutide Alfa at 5, 10, or 20 mg or placebo for up to 12 weeks in a 3:1 ratio. The trial will monitor adverse events, labs, vital signs, ECGs, and immunogenicity to understand risk and potential effects on weight-related biology. The study aims to establish PK/PD relationships and inform future development in this population.

Why it matters

Potential benefit: If successful, participants could experience improvements in weight management and metabolic factors, with broader implications for adolescent obesity treatment.

How similar studies have gone: Prior GLP-1 receptor agonist studies in adults show weight loss potential, with limited data in adolescents; this program explores safety and dosing in youths, representing a relatively novel pediatric evaluation.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Beijing Chaoyang Hospital, Capital Medical University
    Beijing, Beijing Municipality, China
    Recruiting
  • Qilu Second Hospital, Shandong University
    Jinan, Shandong, China
    Recruiting
  • Wuhan Central Hospital
    Wuhan, Hubei, China
    Not yet recruiting
  • Shengjing Hospital, China Medical University
    Shenyang, Liaoning, China
    Not yet recruiting
  • Qilu Hospital, Shandong University
    Jinan, Shandong, China
    Not yet recruiting

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.