Status:
RECRUITING
A Study of XW003 Injection in Chinese Adolescents With Obesity
Lead Sponsor:
Hangzhou Sciwind Biosciences Co., Ltd.
Conditions:
Obese Adolescents
Obesity
Eligibility:
All Genders
12-18 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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;
- 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
- Pre-adolescent participants (Tanner phase I);
- 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.;
- Have used any weight-loss drugs, hypoglycemic drugs, or drugs that may cause significant weight gain within 3 months prior to screening;
- Diagnosis with any type of diabetes;
- History of acute or chronic pancreatitis, history of gallbladder disease or pancreatic injury
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT07143227
Start Date
August 25 2025
End Date
December 31 2026
Last Update
September 12 2025
Active Locations (1)
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1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012