NCT05813795

Brief Summary

The aim of the study is to evaluate the efficacy and safety of XW003 versus placebo in adults with overweight or obesity

Trial Health

87
On Track

Trial Health Score

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

Enrollment
664

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 20, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

April 5, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

April 30, 2025

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

March 20, 2023

Last Update Submit

April 28, 2025

Conditions

Weight Management

Keywords

Weight managementoverweightobesityglucagon-like peptide-1 (GLP-1)ecnoglutideXW003

Outcome Measures

Primary Outcomes (2)

  • Percent change in body weight from baseline

    Week 40

  • Proportion of subjects with weight loss ≥5% from baseline

    Week 40

Secondary Outcomes (4)

  • Percent and absolute body weight change from baseline

    Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48

  • Proportion of subjects with weight loss ≥ 5%, 10%, 15% from baseline

    Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48

  • Change from baseline in BMI

    Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48

  • Change from baseline in waist and hip circumferences

    Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48

Study Arms (6)

C1- XW003 Low Dosage

EXPERIMENTAL

XW003 with low dosage once weekly

Drug: Ecnoglutide Low Dosage

C1-Placebo

PLACEBO COMPARATOR

Matched Placebo once weekly

Drug: Placebo

C2- XW003 Medium Dosage

EXPERIMENTAL

XW003 with medium dosage once weekly

Drug: Ecnoglutide Medium Dosage

C2-Placebo

PLACEBO COMPARATOR

Matched Placebo once weekly

Drug: Placebo

C3- XW003 High Dosage

EXPERIMENTAL

XW003 with high dosage once weekly

Drug: Ecnoglutide High Dosage

C3-Placebo

PLACEBO COMPARATOR

Matched Placebo once weekly

Drug: Placebo

Interventions

Ecnoglutide Low DosageDRUG

Subcutaneous Injection

Also known as: XW003
C1- XW003 Low Dosage
Ecnoglutide Medium DosageDRUG

Subcutaneous Injection

Also known as: XW003
C2- XW003 Medium Dosage
Ecnoglutide High DosageDRUG

Subcutaneous Injection

Also known as: XW003
C3- XW003 High Dosage
PlaceboDRUG

Subcutaneous Injection with matched volume

C1-PlaceboC2-PlaceboC3-Placebo

Eligibility Criteria

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

You may qualify if:

  • Male or female, 18-75 years old, inclusive;
  • BMI between 24.0 to 28.0 kg/m2 with at least one comorbidity, including prediabetes, hypertension, hyperlipidemia, fatty liver , obstructive sleep apnea syndrome, etc.; or BMI ≥ 28 kg/m2 with or without comorbidities.
  • Weight change of no more than 5% (based on self-report), with diet and exercise alone, within 3 months before screening.
  • Willing and able to maintain stable diet and exercise during the study period.

You may not qualify if:

  • Obesity induced by endocrine diseases such as hypothyroidism, Cushing Syndrome, etc.
  • History of bariatric surgery (except liposuction \>1 year ago) or planned bariatric surgery during the study period.
  • Within 3 months before screening, history of using the following drugs or treatments:
  • Any approved or unapproved weight-loss drugs or Chinese herbs or health products that affect body weight.
  • Any hypoglycemic medication.
  • Any medication that may cause significant weight gain, including systemic glucocorticoid treatment, tricyclic anti-depressants, anti-epileptic and antipsychotics.
  • Any investigational drug, vaccine, or medical device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

  • Ji L, Gao L, Xue H, Tian J, Wang K, Jiang H, Huang C, Lian Q, Yuan M, Gao G, Lu Y, Han J, Fu W, Wang H, Zhang Y, Shi X, Wen B, Shi B, Hu W, Guo T, Xing Y, Li Y, Li Q, Zheng Q, Yang M, Ning J, Guo M, Li Y, Pan H. Efficacy and safety of a biased GLP-1 receptor agonist ecnoglutide in adults with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2025 Sep;13(9):777-789. doi: 10.1016/S2213-8587(25)00141-X. Epub 2025 Jun 21.

    PMID: 40555243DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition 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 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 14, 2023

Study Start

April 5, 2023

Primary Completion

June 20, 2024

Study Completion

October 10, 2024

Last Updated

April 30, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)