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

Sponsor

Hangzhou Sciwind Biosciences Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05813795

Collaborator

(none)

660

Enrollment

Location

Arms

21.4

Anticipated Duration (Months)

30.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Weight Management	Drug: Ecnoglutide Low Dosage Drug: Ecnoglutide Medium Dosage Drug: Ecnoglutide High Dosage Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

660 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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)

Anticipated Study Start Date :

Apr 12, 2023

Anticipated Primary Completion Date :

Jan 22, 2025

Anticipated Study Completion Date :

Jan 22, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Percent change in body weight from baseline [Week 40]
Proportion of subjects with weight loss ≥5% from baseline [Week 40]

Secondary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.