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)
Overview
- Phase
- Phase 3
- Intervention
- Ecnoglutide Medium Dosage
- Conditions
- Weight Management
- Sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
- Enrollment
- 664
- Locations
- 1
- Primary Endpoint
- Percent change in body weight from baseline
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
C2- XW003 Medium Dosage
XW003 with medium dosage once weekly
Intervention: Ecnoglutide Medium Dosage
C1- XW003 Low Dosage
XW003 with low dosage once weekly
Intervention: Ecnoglutide Low Dosage
C1-Placebo
Matched Placebo once weekly
Intervention: Placebo
C2-Placebo
Matched Placebo once weekly
Intervention: Placebo
C3- XW003 High Dosage
XW003 with high dosage once weekly
Intervention: Ecnoglutide High Dosage
C3-Placebo
Matched Placebo once weekly
Intervention: Placebo
Outcomes
Primary Outcomes
Percent change in body weight from baseline
Time Frame: Week 40
Proportion of subjects with weight loss ≥5% from baseline
Time Frame: Week 40
Secondary Outcomes
- 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)
- 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)