A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity

Phase 3

Completed

• Conditions: Weight Management
• Interventions: Drug: Ecnoglutide Medium Dosage; Drug: Placebo; Drug: Ecnoglutide Low Dosage; Drug: Ecnoglutide High Dosage

• Registration Number: NCT05813795
• Lead Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

Brief Summary

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

Detailed Description

In this Phase 3 study, eligible participants will be randomized into three cohorts in a 3:1:3:1:3:1 ratio to receive once-weekly subcutaneous XW003 (low, medium, or high dosage) or volume-matching placebo for 48 weeks, including a dose-escalation period.

Study Timeline

• Study First Submitted: 2023-03-20
• Study Start: 2023-04-05
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-14
• Primary Completion: 2024-06-20
• Status Verified: 2024-07
• Study Completion: 2024-10-10
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 664

Inclusion Criteria

1. Male or female, 18-75 years old, inclusive;
2. 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.
3. Weight change of no more than 5% (based on self-report), with diet and exercise alone, within 3 months before screening.
4. Willing and able to maintain stable diet and exercise during the study period.

Exclusion Criteria

1. Obesity induced by endocrine diseases such as hypothyroidism, Cushing Syndrome, etc.

2. History of bariatric surgery (except liposuction >1 year ago) or planned bariatric surgery during the study period.

3. Within 3 months before screening, history of using the following drugs or treatments:

   1. Any approved or unapproved weight-loss drugs or Chinese herbs or health products that affect body weight.
   2. Any hypoglycemic medication.
   3. Any medication that may cause significant weight gain, including systemic glucocorticoid treatment, tricyclic anti-depressants, anti-epileptic and antipsychotics.
   4. Any investigational drug, vaccine, or medical device.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C2- XW003 Medium Dosage	Ecnoglutide Medium Dosage	XW003 with medium dosage once weekly
C2-Placebo	Placebo	Matched Placebo once weekly
C1- XW003 Low Dosage	Ecnoglutide Low Dosage	XW003 with low dosage once weekly
C1-Placebo	Placebo	Matched Placebo once weekly
C3- XW003 High Dosage	Ecnoglutide High Dosage	XW003 with high dosage once weekly
C3-Placebo	Placebo	Matched Placebo once weekly

Primary Outcome Measures

Name	Time	Method
Percent change in body weight from baseline	Week 40
Proportion of subjects with weight loss ≥5% from baseline	Week 40

Secondary Outcome Measures

Name	Time	Method
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	height will be only measured at baseline
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
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

Trial Locations

Locations (1)

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