Weight Management
Conditions
Keywords
Weight management, overweight, obesity, glucagon-like peptide-1 (GLP-1), ecnoglutide, XW003
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.
Interventions
Subcutaneous Injection
DRUGEcnoglutide Medium Dosage
Subcutaneous Injection
Subcutaneous Injection
DRUGPlacebo
Subcutaneous Injection with matched volume
Sponsors
Hangzhou Sciwind Biosciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in body weight from baseline | Week 40 |
| Proportion of subjects with weight loss ≥5% from baseline | Week 40 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Outcome results
None listed