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

NCT ID: NCT07073417

Last Updated: 2025-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-28

Study Completion Date

2027-08-23

Brief Summary

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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

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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.

Conditions

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Obesity Weight Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XW003

once weekly

Group Type EXPERIMENTAL

XW003 injection

Intervention Type DRUG

Subcutaneous injection

semaglutide

once weekly

Group Type ACTIVE_COMPARATOR

semaglutide injection

Intervention Type DRUG

Subcutaneous injection

Interventions

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XW003 injection

Subcutaneous injection

Intervention Type DRUG

semaglutide injection

Subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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ecnoglutide

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hangzhou Sciwind Biosciences Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linong Ji, Dr

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yao Li

Role: CONTACT

(86) 010-87120826

Facility Contacts

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Linong Ji, Dr

Role: primary

(86)010-88324516

Other Identifiers

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SCW0502-1122

Identifier Type: -

Identifier Source: org_study_id

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