A Study of XW003 Injection in Chinese Adolescents With Obesity

Not Applicable

Not yet recruiting

• Conditions: Obese Adolescents; Obesity
• Interventions: Drug: XW003 injection; Drug: placebo with matching volume

• Registration Number: NCT07143227
• Lead Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-13
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study Start: 2025-08-20
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
XW003 Dose 1	XW003 injection	once weekly
XW003 Dose 2	XW003 injection	once weekly
XW003 Dose 3	XW003 injection	once weekly
placebo	placebo with matching volume	once weekly

Primary Outcome Measures

Name	Time	Method
Number and severity of adverse events	week 20

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of XW003	week 20
Change of body weight from baseline	week 20

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China