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

A Phase 3, Multi-center, Randomized, Double-Blind and Placebo-controlled Study to Evaluate the Efficacy and Safety of XW003 in Adults With Overweight or Obesity (SLIMMER)

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

Study Overview

• Status: Completed
• Conditions: Weight Management
• Intervention / Treatment: Drug: Placebo; Drug: Ecnoglutide Low Dosage; Drug: Ecnoglutide Medium Dosage; Drug: Ecnoglutide High Dosage

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 Type: Interventional
• Enrollment (Actual): 664
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: C1-Placebo; Matched Placebo once weekly	Drug: Placebo; Subcutaneous Injection with matched volume
Placebo Comparator: C2-Placebo; Matched Placebo once weekly	Drug: Placebo; Subcutaneous Injection with matched volume
Experimental: C1- XW003 Low Dosage; XW003 with low dosage once weekly	Drug: Ecnoglutide Low Dosage; Subcutaneous Injection; Other Names: XW003
Experimental: C2- XW003 Medium Dosage; XW003 with medium dosage once weekly	Drug: Ecnoglutide Medium Dosage; Subcutaneous Injection; Other Names: XW003
Experimental: C3- XW003 High Dosage; XW003 with high dosage once weekly	Drug: Ecnoglutide High Dosage; Subcutaneous Injection; Other Names: XW003
Placebo Comparator: C3-Placebo; Matched Placebo once weekly	Drug: Placebo; Subcutaneous Injection with matched volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in body weight from baseline	Week 40
Proportion of subjects with weight loss ≥5% from baseline	Week 40

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	height will be only measured at 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 waist and hip circumferences		Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48

Collaborators and Investigators

• Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
• Investigators: Principal Investigator: Linong Ji, Dr, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2023
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): October 10, 2024

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: obesity; overweight; Weight management; glucagon-like peptide-1 (GLP-1); XW003; ecnoglutide
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: SCW0502-1131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No