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A Study of XW003 Injection in Chinese Adolescents With Obesity
A Randomized, Double-blind, Placebo-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of XW003 Injection in Chinese Adolescents With Obesity
Lead sponsor
Asset
Ecnoglutide (XW003)
GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
48
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI 586-2018
Primary endpoint
•Treatment-emergent AEs (any)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. At the time of screening, BMI meets the obesity criteria specified in WS/T586-2018 'screening for overweight and obesity among school-aged children and adolescents', and weight ≥55 kg;
2. At the time of screening, the decrease of body mass index less than 5% after diet and exercise control alone for at least 12 weeks (as reported by participants or parents or legal guardians);
Exclusion criteria
1. Pre-adolescent participants (Tanner phase I);
2. Obesity caused by secondary diseases or medications, including: elevated cortisol hormone (e.g. Cushing's syndrome), damage to the pituitary gland and hypothalamus, reduced dosage/discontinuation of weight-loss drugs or monogenic obesity, etc.;
3. Have used any weight-loss drugs, hypoglycemic drugs, or drugs that may cause significant weight gain within 3 months prior to screening;
4. Diagnosis with any type of diabetes;
5. History of acute or chronic pancreatitis, history of gallbladder disease or pancreatic injury
Endpoints (3)
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
1 endpointChange of body weight from baseline
Time frame:week 20
Body weight, absolute change (kg)
change from baseline, improvement
Safety / tolerability / PK
2 endpointsNumber and severity of adverse events
Time frame:week 20
Treatment-emergent AEs (any)
descriptive
Plasma concentrations of XW003
Time frame:week 20
Plasma concentration (steady state)
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 July 1, 2026 snapshot.