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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07836270
- Acronym / sponsor ID
- SCW0502-1132
- Keywords
- Weight management, ecnoglutide, adolescent, obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 8 Jun 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the safety and efficacy of Ecnoglutide injection in overweight or obese Chinese adolescents
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ecnoglutide Injection Dose 1 | Experimental | Drug: Ecnoglutide Injectiononce weekly |
| Ecnoglutide Injection Dose 2 | Experimental | Drug: Ecnoglutide Injectiononce weekly |
| Ecnoglutide Injection Dose 3 | Experimental | Drug: Ecnoglutide Injectiononce weekly |
| placebo | Placebo comparator | Drug: placebo with matching volumeonce weekly |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecnoglutide InjectionSubcutaneous injection | Drug | Ecnoglutide Injection Dose 1, Ecnoglutide Injection Dose 2, Ecnoglutide Injection Dose 3 |
| placebo with matching volumeSubcutaneous injection | Drug | placebo |
Primary outcome
Percent change in Body Mass Index (BMI)
Time frame: Baseline, week 40
15 secondary outcomes
Percentage of participants with ≥5% of BMI reduction
Time frame: Baseline, week 40 and week 52
Change in BMI
Time frame: Baseline, week 52
Percentage of participants with ≥10% of BMI reduction
Time frame: Baseline, week 52
Percentage of participants with ≥15% of BMI reduction
Time frame: Baseline, week 52
Percentage of participants with ≥20% of BMI reduction
Time frame: Baseline, week 52
Change in body weight
Time frame: Baseline, week 52
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline, week 52
Change in Fasting Plasma Glucose (FPG)
Time frame: Baseline, week 52
Change in Fasting Insulin
Time frame: Baseline, week 52
Change in Homeostasis Model Assessment 2 - Insulin Resistance (HOMA2-IR)
Time frame: Baseline, week 52
Change in Homeostasis Model Assessment 2 - Beta Cell Function (HOMA2-β)
Time frame: Baseline, week 52
Change in lipid profile
Time frame: Baseline, week 52
Change in liver enzymes
Time frame: Baseline, week 52
Adverse events
Time frame: From week1 to week 57
Trough concentration of ecnoglutide
Time frame: From baseline to week 57 (EOS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Junfen Fu, Dr principal investigator
The Children's Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao Li (010-67889255, ra@sciwindbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in Body Mass Index (BMI) (time frame: Baseline, week 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.