A Study of XW003 Injection in Chinese Adolescents With Obesity

NCT07143227 | Active Not Recruiting Phase 1

• 1 other identifier: SCW0502-1111
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obese Adolescents; Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number and severity of adverse events

  week 20

Secondary Outcomes (2)

• Plasma concentrations of XW003

  week 20

• Change of body weight from baseline

  week 20

Study Arms (4)

XW003 Dose 1

EXPERIMENTAL

once weekly

Drug: XW003 injection

XW003 Dose 2

EXPERIMENTAL

once weekly

Drug: XW003 injection

XW003 Dose 3

EXPERIMENTAL

once weekly

Drug: XW003 injection

placebo

PLACEBO COMPARATOR

once weekly

Drug: placebo with matching volume

Interventions

placebo with matching volume DRUG

Subcutaneous injection

placebo

XW003 injection DRUG

Subcutaneous injection

XW003 Dose 1; XW003 Dose 2; XW003 Dose 3

Eligibility Criteria

• Age: 12 Years - 18 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• Hangzhou Sciwind Biosciences Co., Ltd.: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Zhao, Dr

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

• Xinguo Hou, Dr

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 27, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)