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

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Weight Management

Intervention / Treatment
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* Drug: Ecnoglutide Low Dosage
* Drug: Ecnoglutide Medium Dosage
* Drug: Ecnoglutide High Dosage
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight management, overweight, obesity, glucagon-like peptide-1 (GLP-1), ecnoglutide, XW003