Active — Not RecruitingPhase 1

A Study of XW003 Injection in Chinese Adolescents With Obesity

China48 participantsStarted 2025-08-25

Plain-language summary

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

Who can participate

Age range12 Years – 18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Number and severity of adverse events

Timeframe: week 20

Trial details

NCT IDNCT07143227

SponsorHangzhou Sciwind Biosciences Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Obese Adolescents trials