A Study of XW003 Injection in Chinese Adolescents With Obesity

Sciwind Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Obesity; Obese Adolescents

Treatments: Drug: placebo with matching volume; Drug: XW003 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07143227

SCW0502-1111

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 4 patient groups, including a placebo group

XW003 Dose 1

Experimental group

Description:

once weekly

Treatment:

Drug: XW003 injection

XW003 Dose 2

Experimental group

Description:

once weekly

Treatment:

Drug: XW003 injection

XW003 Dose 3

Experimental group

Description:

once weekly

Treatment:

Drug: XW003 injection

placebo

Placebo Comparator group

Description:

once weekly

Treatment:

Drug: placebo with matching volume