RecruitingPhase 1

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

Lead sponsor

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Asset

Efsubaglutide Alfa

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight

Eligibility highlights

•Age 12-17

Primary endpoints

•Safety and tolerability•Pharmacokinetic (PK) characteristics at steady state following multiple doses

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07693426

Org study IDYN012Y-Ib-W102

Timeline

Milestones

Study first posted2026-07-09actual

Study start2026-07-16actual

Last update posted2026-07-30actual

Primary completion2027-04-30estimated

Study completion2027-08-31estimated

Assets

Investigational agents

Efsubaglutide Alfa

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age12 Years

Maximum age17 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

10 endpoints

Secondary/protocol endpoint

Change in body mass index (BMI) from baseline (absolute and percentage)

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI from baseline over time (absolute and percentage)

Time frame:Weeks 4, 8, and 12

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting body weight from baseline (absolute and percentage)

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting body weight from baseline over time (absolute and percentage)

Time frame:Weeks 4, 8, and 12

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference from baseline

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in waist-to-hip ratio (WHR) from baseline

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in waist-to-height ratio from baseline

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Proportion of participants achieving ≥5%, ≥10%, and ≥15% reduction in BMI and/or fasting body weight from baseline

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

The correlation between Efsubaglutide Alfa Cmax, ss and BMI

Time frame:Throughout the study (up to Week 18)

concentration, descriptive

Secondary/protocol endpoint

The correlation between Efsubaglutide Alfa AUC0-168h, ss and BMI

Time frame:Throughout the study (up to Week 18)

descriptive

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change in fasting blood glucose from baseline

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in HbA1c from baseline

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting insulin from baseline

Time frame:Week 12

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Change in systolic blood pressure and diastolic blood pressure from baseline

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in lipid levels(TC、HDL-C、LDL-C、TG) from baseline

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change in blood uric acid from baseline

Time frame:Week 12

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Safety and tolerability: incidence of TEAEs, SAEs, and AESI

Time frame:Throughout the study (up to Week 18)

event count, event

Primary/protocol endpoint

Pharmacokinetic (PK) characteristics at steady state following multiple doses

Time frame:Throughout the study (up to Week 18)

descriptive

Secondary/protocol endpoint

Incidence, titer, and persistence of anti-drug antibodies (ADA)

Time frame:Throughout the study (up to Week 18)

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change in hip circumference from baseline

Time frame:Week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Incidence, titer, and persistence of neutralizing antibodies

Time frame:Throughout the study (up to Week 18)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.