Adolescents With ObesityPhase 3NCT07836270
A Study of Ecnoglutide Injection in Overweight or Obese Chinese Adolescents
A Phase 3 study testing Ecnoglutide Injection in people with Adolescents With Obesity and Adolescents With Overweight & Weight-related Comorbidities, run by Hangzhou Sciwind Biosciences Co., Ltd. at 1 site in China.
Trial summary
The aim of the study is to evaluate the safety and efficacy of Ecnoglutide injection in overweight or obese Chinese adolescents Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Adolescents With Obesity, Adolescents With Overweight & Weight-related Comorbidities
- What is being tested?
- Ecnoglutide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2026to 30 Sep 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- At screening, the BMI 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.
- Participant with body weight loss <5% by diet and exercise for at least 3 months before screening (per self, parental/legal report).
Who cannot join
- Pre-adolescent participants (Tanner phase 1);
- 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);
- 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.;
- Diagnosis with any type of diabetes;
- History of acute or chronic pancreatitis, history of gallbladder disease or pancreatic injury;
- History of using any approved or unapproved drugs for weight loss, antidiabetic drugs, long-term systemic glucocorticoids (more than 14 days), within 3 months prior to screening;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Junfen Fu, Dr, +86-13777457849, ra@sciwindbio.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Safety and Efficacy of Ecnoglutide Injection in Overweight or Obese Chinese Adolescents (SLIMMER-YOUNG)
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
- Being tested
- Ecnoglutide Injection, placebo with matching volume
- Keywords
- Weight management, ecnoglutide, adolescent, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecnoglutide InjectionDrug
Subcutaneous injection
placebo with matching volumeDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Ecnoglutide Injection Dose 1 | Experimental | once weekly Receives: Drug: Ecnoglutide Injection |
| Ecnoglutide Injection Dose 2 | Experimental | once weekly Receives: Drug: Ecnoglutide Injection |
| Ecnoglutide Injection Dose 3 | Experimental | once weekly Receives: Drug: Ecnoglutide Injection |
| placebo | Placebo comparator | once weekly Receives: Drug: placebo with matching volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in Body Mass Index (BMI)
Measured: Baseline, week 40
Secondary outcomes (15)
Percentage of participants with ≥5% of BMI reduction
Measured: Baseline, week 40 and week 52
Change in BMI
Include percent change and absolute change
Measured: Baseline, week 52
Percentage of participants with ≥10% of BMI reduction
Measured: Baseline, week 52
Percentage of participants with ≥15% of BMI reduction
Measured: Baseline, week 52
Percentage of participants with ≥20% of BMI reduction
Measured: Baseline, week 52
Change in body weight
Include percent change and absolute change
Measured: Baseline, week 52
Change in Glycated Hemoglobin (HbA1c)
Measured: Baseline, week 52
Change in Fasting Plasma Glucose (FPG)
Measured: Baseline, week 52
Change in Fasting Insulin
Measured: Baseline, week 52
Change in Homeostasis Model Assessment 2 - Insulin Resistance (HOMA2-IR)
Measured: Baseline, week 52
Change in Homeostasis Model Assessment 2 - Beta Cell Function (HOMA2-β)
Measured: Baseline, week 52
Change in lipid profile
Include triglycerides, LDL-C, HDL-C, total cholesterol
Measured: Baseline, week 52
Change in liver enzymes
Include alanine aminotransferase, aspartate aminotransferase and gamma-glutamyl transferase
Measured: Baseline, week 52
Adverse events
Incidence and severity
Measured: From week1 to week 57
Trough concentration of ecnoglutide
Measured: From baseline to week 57 (EOS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start31 Oct 2026 (estimated)
- Primary completion8 Jun 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescents With ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junfen Fu, Dr, Principal investigator, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836270
- Sponsor's protocol ID
- SCW0502-1132
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No