A Study to Compare XW003 Injection and Semaglutide Injection in Chinese Adults With Obesity (SLIMMER-UP-SWITCH)

Not Applicable

Recruiting

• Conditions: Obesity; Weight Management
• Interventions: Drug: XW003 injection; Drug: semaglutide injection

• Registration Number: NCT07073417
• Lead Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

Brief Summary

The aim of the study is to compare the efficacy and safety of XW003 injection versus semaglutide injection in Chinese adults with obesity

Detailed Description

In this Phase II study, eligible participants will be randomized into one of the two cohorts in a 1:1 ratio to receive once-weekly subcutaneous XW003 injection or semaglutide injection, including a dose-escalation period, a core treatment period and a treatment extension period, for up to 60 weeks.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Study First Posted: 2025-07-18
• Study Start: 2025-07-28
• Last Update Submitted: 2025-08-19
• Last Update Posted: 2025-08-20
• Primary Completion: 2027-02-27
• Study Completion: 2027-08-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• BMI≥30 kg/m2 at screening, waist circumference ≥90 cm for men and ≥85 cm for women.
• Weight change of less than 5% within 3 months prior to screening (self-reported).

Exclusion Criteria

• Diagnosis of obesity due to endocrine disorders or a single gene mutation, including but not limited to hypothalamic obesity, pituitary obesity, Cushing's syndrome, hypothyroidic obesity (except for those with normal thyroid function at screening and expected to remain unchanged throughout the trial period after at least 3 months of thyroid hormone replacement therapy), insulinoma, acromegaly.
• History of bariatric surgery or planning to undergo bariatric surgery or use other weight-loss drugs or devices during the trial (except acupuncture for weight loss, liposuction, or abdominal fat removal for more than one year before screening; Except the removal or expulsion of the airbag in the stomach for more than 1 year before screening.
• Diagnosis with any type of diabetes (except gestational diabetes).
• Have used any weight-loss drugs, hypoglycemic drugs, or drugs that may cause significant weight gain within 3 months prior to screening.
• History of acute or chronic pancreatitis or pancreatic injury, history of symptomatic gallbladder disease (except cholecystectomy).
• History of clinically significant gastric emptying abnormalities, such as gastroparesis or gastric outlet obstruction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
XW003	XW003 injection	once weekly
semaglutide	semaglutide injection	once weekly

Primary Outcome Measures

Name	Time	Method
Percentage change in body weight relative to baseline	week 48

Secondary Outcome Measures

Name	Time	Method
Proportions of participants with weight loss ≥5% from baseline	week 48
Proportions of participants with weight loss ≥10% from baseline	week 48
Proportions of participants with weight loss ≥15% from baseline	week 48
The change in waist circumference relative to the baseline	week 48
Changes in body mass index (BMI) relative to baseline	week 48

Trial Locations

Locations (2)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China