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CompletedPhase 1

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

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

NCT IDNCT07143227
Org study IDSCW0502-1111

Timeline

Milestones

Study start2025-08-25actual
Study first posted2025-08-27actual
Primary completion2026-04-18actual
Study completion2026-04-18actual
Last update posted2026-05-20actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years
Maximum age18 Years
SexAll
Healthy volunteersAccepted

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

Safety / tolerability / PK
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change of body weight from baseline

Time frame:week 20

Body weight, absolute change (kg)

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Number and severity of adverse events

Time frame:week 20

Treatment-emergent AEs (any)

descriptive

Secondary/protocol endpoint

Plasma concentrations of XW003

Time frame:week 20

Plasma concentration (steady state)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.