A Study of Ecnoglutide Injection in Overweight or Obese Chinese Adolescents
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)
Lead sponsor
Asset
Ecnoglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
-
Estimated enrollment
192
Study population
Obesity / overweight
Eligibility highlights
•BMI 586-2018•Age 12-17
Primary endpoint
•Body Mass Index (BMI)
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
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. 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.
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
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 glucocorticoids (more than 14 days), within 3 months prior to screening;
Endpoints (16)
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
7 endpointsPercent change in Body Mass Index (BMI)
Time frame:Baseline, week 40
percent change from baseline, improvement
Percentage of participants with ≥5% of BMI reduction
Time frame:Baseline, week 40 and week 52
threshold achievement, improvement
Change in BMI
Time frame:Baseline, week 52
change from baseline, improvement
Percentage of participants with ≥10% of BMI reduction
Time frame:Baseline, week 52
threshold achievement, improvement
Percentage of participants with ≥15% of BMI reduction
Time frame:Baseline, week 52
threshold achievement, improvement
Percentage of participants with ≥20% of BMI reduction
Time frame:Baseline, week 52
threshold achievement, improvement
Change in body weight
Time frame:Baseline, week 52
change from baseline, improvement
Glycemic / diabetes
4 endpointsChange in Glycated Hemoglobin (HbA1c)
Time frame:Baseline, week 52
change from baseline, improvement
Change in Fasting Plasma Glucose (FPG)
Time frame:Baseline, week 52
change from baseline, improvement
Change in Fasting Insulin
Time frame:Baseline, week 52
change from baseline, improvement
Change in Homeostasis Model Assessment 2 - Insulin Resistance (HOMA2-IR)
Time frame:Baseline, week 52
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointChange in lipid profile
Time frame:Baseline, week 52
change from baseline, improvement
Safety / tolerability / PK
1 endpointAdverse events
Time frame:From week1 to week 57
descriptive
Other (unclassified)
3 endpointsChange in Homeostasis Model Assessment 2 - Beta Cell Function (HOMA2-β)
Time frame:Baseline, week 52
change from baseline, improvement
Change in liver enzymes
Time frame:Baseline, week 52
change from baseline, improvement
Trough concentration of ecnoglutide
Time frame:From baseline to week 57 (EOS)
concentration, descriptive
Provenance
Sources
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.