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

Last updated: April 28, 2025
Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Diabetes Prevention

Weight Loss

Obesity

Treatment

Ecnoglutide Low Dosage

Ecnoglutide Medium Dosage

Ecnoglutide High Dosage

Clinical Study ID

NCT05813795
SCW0502-1131
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 exercisealone, within 3 months before screening.

  4. Willing and able to maintain stable diet and exercise during the study period.

Exclusion

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 bariatricsurgery during the study period.

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

  4. Any approved or unapproved weight-loss drugs or Chinese herbs or healthproducts that affect body weight.

  5. Any hypoglycemic medication.

  6. Any medication that may cause significant weight gain, including systemicglucocorticoid treatment, tricyclic anti-depressants, anti-epileptic andantipsychotics.

  7. Any investigational drug, vaccine, or medical device.

Study Design

Total Participants: 664
Treatment Group(s): 4
Primary Treatment: Ecnoglutide Low Dosage
Phase: 3
Study Start date:
April 05, 2023
Estimated Completion Date:
October 10, 2024

Study 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.

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing
    China

    Site Not Available

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