NCT07073417

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
16mo left

Started Jul 2025

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Jul 2025Aug 2027

First Submitted

Initial submission to the registry

July 9, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

July 28, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2027

Last Updated

April 13, 2026

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

July 9, 2025

Last Update Submit

April 9, 2026

Conditions

Keywords

Weight managementobesityXW003glucagon-like peptide-1 (GLP-1)ecnoglutidesemaglutide

Outcome Measures

Primary Outcomes (1)

  • Percentage change in body weight relative to baseline

    week 48

Secondary Outcomes (5)

  • 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

Study Arms (2)

XW003

EXPERIMENTAL

once weekly

Drug: XW003 injection

semaglutide

ACTIVE COMPARATOR

once weekly

Drug: semaglutide injection

Interventions

Subcutaneous injection

Also known as: ecnoglutide
XW003

Subcutaneous injection

semaglutide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Linong Ji, Dr

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 18, 2025

Study Start

July 28, 2025

Primary Completion (Estimated)

February 27, 2027

Study Completion (Estimated)

August 23, 2027

Last Updated

April 13, 2026

Record last verified: 2025-07

Locations