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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07143227

Enrollment

Registered

2025-08-27

Start date

2025-08-25

Completion date

2026-12-31

Last updated

2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese Adolescents, Obesity

Keywords

Weight management, obesity, XW003, ecnoglutide, glucagon-like peptide-1 (GLP-1), adolescent

Brief summary

The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XW003 injection in Chinese adolescents with obesity

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 XW003 injection or placebo, for up to 20 weeks.

Interventions

DRUGXW003 injection

Subcutaneous injection

DRUGplacebo with matching volume

Subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Number and severity of adverse events	week 20

Secondary

Measure	Time frame
Plasma concentrations of XW003	week 20
Change of body weight from baseline	week 20

Countries

China

Contacts

PRINCIPAL_INVESTIGATORWei Zhao, Dr

Qilu Hospital of Shandong University

PRINCIPAL_INVESTIGATORXinguo Hou, Dr