ClinicalTrials.gg
RecruitingNCT07693426Updated Jul 30, 2026

Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents

A Phase 1 interventional study of Efsubaglutide Alfa 5 mg QW and Efsubaglutide Alfa 10 mg QW in Adolescence Obesity, sponsored by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.. Recruiting at 5 sites in China. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 35 studies in Pediatric Obesity with a site in China — 16 open to participants now, 17 under way, none of them phase 3. Pediatric Obesity · China.

Planned enrollment
20th of 21
36 · median 140
Started
2026
with 3 others
Phase 1
Only one
of the 35
Primary completion
2027-04
later than 11 of 16 live
Registered
33rd of 35
by date

Among the 35 studies in Pediatric Obesity with a site in China, this one is the 20th largest by planned enrollment of the 21 interventional ones that give a count, is one of 4 that started in 2026, is the only one in phase 1, reaches primary completion later than 11 of the 16 other live ones, and was the 33rd registered.

Pediatric Obesity

1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.

Browse Pediatric Obesity studies →

Open to participants now

16 of the 35 studies in Pediatric Obesity with a site in China are open now. Recruiting first, the newest first:

10 more — sign in →

All 16 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 124 Pediatric Obesity studies recruiting now, 19 (15%) set no upper age limit and 103 (83%) stop at 75 or younger; 114 take children under 18; 69 take healthy volunteers.

This study: 12 Years to 17 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

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 the detailed description

The prevalence of obesity in adolescents is rising and threatening physiological and psychological health. Different from adults with obesity, there is still no approved drug to manage the obesity in adolescents, In order to provide the therapeutical option earlier, the weight-reduction study in obese adolescents is planned. The primary objective of this Phase Ib study is to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of multiple doses of Efsubaglutide Alfa at different dose levels in Chinese adolescent participants with obesity. The secondary objectives include the evaluations of the pharmacodynamic (PD) effects, PK-PD relationship , and immunogenicity of multiple doses of Efsubaglutide Alfa at different dose levels. This randomized, double-blind, placebo-controlled, parallel-group study will enroll a total of 36 adolescent participants aged 12 to 17 years with obesity . 36 participants will be randomized in a 3:1 ratio to receive Efsubaglutide Alfa or placebo administered subcutaneously once weekly (QW) for up to 12 weeks. Safety will be monitored throughout the study by assessment of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESI), laboratory parameters, vital signs, and 12-lead electrocardiograms.

03

Conditions studied

  • Adolescence Obesity

Keywords

  • Efsubaglutide Alfa
  • GLP-1 receptor agonist
  • Adolescent Obesity
  • weight loss
04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. 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 (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 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

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 planning pregnancy or unwilling to use highly effective 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. 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 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× at screening.
  • 13. Known or suspected drug/substance abuse at screening; positive ;
  • 14. Positive antibody with HCV RNA above the lower limit of detection; positive antibody; positive Tp-Ab.
  • 15. Currently receiving or received chronic (>14 days) systemic therapy within 3 months prior to screening, or evidence of severe active 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; >3.0×ULN, or AST >3.0×ULN, or total >2.0×ULN; \<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 \<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.
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Efsubaglutide Alfa 5 mg QW

    Efsubaglutide Alfa, 5 mg once weekly,12 weeks Solution for injection in pre-filled auto-injector pen

    Drug: Efsubaglutide Alfa 5 mg QW

  • Experimental
    Efsubaglutide Alfa 10 mg QW

    Efsubaglutide Alfa, 10 mg once weekly,12 weeks Solution for injection in pre-filled auto-injector pen

    Drug: Efsubaglutide Alfa 10 mg QW

  • Experimental
    Efsubaglutide Alfa 20 mg QW

    Efsubaglutide Alfa, 20 mg once weekly,12 weeks Solution for injection in pre-filled auto-injector pen

    Drug: Efsubaglutide Alfa 20 mg QW

  • Placebo comparator
    Efsubaglutide Alfa placebo

    Efsubaglutide Alfa placebo, once weekly,12 weeks Solution for injection in pre-filled auto-injector pen

    Drug: Efsubaglutide Alfa placebo

Interventions

06

What researchers measure

Primary outcomes

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

    Safety and tolerability assessed by monitoring treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESI) throughout the study

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

  2. Pharmacokinetic (PK) characteristics at steady state following multiple doses

    PK parameters including plasma drug concentrations at steady state following multiple-dose administration of Efsubaglutide Alfa

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

Secondary outcomes

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

    Change in BMI from baseline at Week 12, measured as absolute value and percentage change

    Time frame: Week 12

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

    Change in BMI from baseline at Weeks 4, 8, and 12, measured as absolute value and percentage change

    Time frame: Weeks 4, 8, and 12

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

    Change in fasting body weight from baseline at Week 12, measured as absolute value and percentage change

    Time frame: Week 12

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

    Change in fasting body weight from baseline at Weeks 4, 8, and 12, measured as absolute value and percentage change

    Time frame: Weeks 4, 8, and 12

  5. Change in waist circumference from baseline

    Change in waist circumference from baseline at Week 12

    Time frame: Week 12

  6. Change in hip circumference from baseline

    Change in hip circumference from baseline at Week 12

    Time frame: Week 12

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

    Change in waist-to-hip ratio (WHR) from baseline at Week 12

    Time frame: Week 12

  8. Change in waist-to-height ratio from baseline

    Change in waist-to-height ratio from baseline at Week 12

    Time frame: Week 12

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

    Time frame: Week 12

  10. Change in systolic blood pressure and diastolic blood pressure from baseline

    Time frame: Week 12

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

    Time frame: Week 12

  12. Change in fasting blood glucose from baseline

    Time frame: Week 12

  13. Change in HbA1c from baseline

    Time frame: Week 12

  14. Change in fasting insulin from baseline

    Time frame: Week 12

  15. Change in blood uric acid from baseline

    Time frame: Week 12

  16. The correlation between Efsubaglutide Alfa Cmax, ss and BMI

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

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

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

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

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

  19. Incidence, titer, and persistence of neutralizing antibodies

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

07

Study locations

2 of 5 sites recruiting
  • Beijing Chaoyang Hospital, Capital Medical University
    Beijing, Beijing Municipality, China
    Recruiting
    • Guang Wang · Contact
  • Wuhan Central Hospital
    Wuhan, Hubei, China
    Not yet recruiting
    • Weihua Wang · Contact
    • Zhongjing Wang · Contact
  • Shengjing Hospital, China Medical University
    Shenyang, Liaoning, China
    Not yet recruiting
    • Xiaoguang Shi · Contact
  • Qilu Hospital, Shandong University
    Jinan, Shandong, China
    Not yet recruiting
    • Xinguo Hou · Contact
    • Shuwen Yu · Contact
  • Qilu Second Hospital, Shandong University
    Jinan, Shandong, China
    Recruiting
    • Shuang Liang · Contact
    • Deqing Sun · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Apr 2027, 9 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2026
First posted
Jul 9, 2026
StartActual
Jul 16, 2026
Primary completionEst.
Apr 30, 2027
CompletionEst.
Aug 31, 2027
Last update
Jul 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07693426
Lead sponsor
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Responsible party
Sponsor
First posted
Jul 9, 2026
Start date
Jul 16, 2026
Primary completion
Apr 30, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Jul 30, 2026

Study contacts

QINGHUA WANG, M.D,Ph.D
Contact
dr.qwang@innogenpharm.com
+862168788225

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Efsubaglutide alfa

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