ClinicalTrials.gg
Not yet recruitingNCT07836270Updated Sep 23, 2026

A Study of Ecnoglutide Injection in Overweight or Obese Chinese Adolescents

A Phase 3 interventional study of Ecnoglutide Injection and placebo with matching volume in Adolescents With Obesity and Adolescents With Overweight & Weight-related Comorbidities, sponsored by Hangzhou Sciwind Biosciences Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Hangzhou Sciwind Biosciences Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
192
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study summary

The aim of the study is to evaluate the safety and efficacy of Ecnoglutide injection in overweight or obese Chinese adolescents

Read the detailed description

In this study, eligible participants will be randomized into one of the three cohorts in a 3:1 ratio to receive either once-weekly subcutaneous Ecnoglutide injection or placebo, for up to 52 weeks

02

Conditions studied

  • Adolescents With Obesity
  • Adolescents With Overweight & Weight-related Comorbidities

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Keywords

  • Weight management
  • ecnoglutide
  • adolescent
  • obesity
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 192 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Hangzhou Sciwind Biosciences Co., Ltd. is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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. At screening, the meets the obesity criteria specified in 'WS/T586-2018 Screening for Overweight and Obesity in School-Aged Children and Adolescents', or it meets the overweight criteria and is accompanied by at least one weight-related comorbidity: hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea syndrome, etc.
  2. Participant with body weight loss \<5% by diet and exercise for at least 3 months before screening (per self, parental/legal report).

Exclusion criteria

Exclusion Criteria:

  1. Pre-adolescent participants (Tanner phase 1);
  2. History of receiving weight loss surgery or plan to undergo weight loss surgery during the study period (excluding acupuncture-based weight loss, liposuction, or abdominal fat removal procedures conducted more than 1 year prior to screening);
  3. Known secondary obesity, including but not limited to that resulting from: hypercortisolism (e.g. Cushing's syndrome), pituitary or hypothalamic lesions, or monogenic obesity, etc.;
  4. Diagnosis with any type of diabetes;
  5. History of acute or chronic pancreatitis, history of gallbladder disease or pancreatic injury;
  6. History of using any approved or unapproved drugs for weight loss, antidiabetic drugs, long-term systemic (more than 14 days), within 3 months prior to screening;
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
192 participants (estimated)

Study arms

  • Experimental
    Ecnoglutide Injection Dose 1

    once weekly

    Drug: Ecnoglutide Injection

  • Experimental
    Ecnoglutide Injection Dose 2

    once weekly

    Drug: Ecnoglutide Injection

  • Experimental
    Ecnoglutide Injection Dose 3

    once weekly

    Drug: Ecnoglutide Injection

  • Placebo comparator
    placebo

    once weekly

    Drug: placebo with matching volume

Interventions

06

What researchers measure

Primary outcomes

  1. Percent change in Body Mass Index (BMI)

    Time frame: Baseline, week 40

Secondary outcomes

  1. Percentage of participants with ≥5% of BMI reduction

    Time frame: Baseline, week 40 and week 52

  2. Change in BMI

    Include percent change and absolute change

    Time frame: Baseline, week 52

  3. Percentage of participants with ≥10% of BMI reduction

    Time frame: Baseline, week 52

  4. Percentage of participants with ≥15% of BMI reduction

    Time frame: Baseline, week 52

  5. Percentage of participants with ≥20% of BMI reduction

    Time frame: Baseline, week 52

  6. Change in body weight

    Include percent change and absolute change

    Time frame: Baseline, week 52

  7. Change in Glycated Hemoglobin (HbA1c)

    Time frame: Baseline, week 52

  8. Change in Fasting Plasma Glucose (FPG)

    Time frame: Baseline, week 52

  9. Change in Fasting Insulin

    Time frame: Baseline, week 52

  10. Change in Homeostasis Model Assessment 2 - Insulin Resistance (HOMA2-IR)

    Time frame: Baseline, week 52

  11. Change in Homeostasis Model Assessment 2 - Beta Cell Function (HOMA2-β)

    Time frame: Baseline, week 52

  12. Change in lipid profile

    Include triglycerides, LDL-C, HDL-C, total cholesterol

    Time frame: Baseline, week 52

  13. Change in liver enzymes

    Include alanine aminotransferase, aspartate aminotransferase and gamma-glutamyl transferase

    Time frame: Baseline, week 52

  14. Adverse events

    Incidence and severity

    Time frame: From week1 to week 57

  15. Trough concentration of ecnoglutide

    Time frame: From baseline to week 57 (EOS)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07836270
Lead sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
Responsible party
Sponsor
First posted
Sep 23, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Jun 8, 2028 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Sep 23, 2026

Study contacts

Yao Li
Contact
ra@sciwindbio.com
010-67889255
Junfen Fu, Dr
principal investigator · The Children's Hospital of Zhejiang University School of Medicine

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ecnoglutide

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