Obesity, Weight Management
Conditions
Keywords
Weight management, obesity, XW003, glucagon-like peptide-1 (GLP-1), ecnoglutide, semaglutide
Brief summary
The aim of the study is to compare the efficacy and safety of XW003 injection versus semaglutide injection in Chinese adults with obesity
Detailed description
In this Phase II study, eligible participants will be randomized into one of the two cohorts in a 1:1 ratio to receive once-weekly subcutaneous XW003 injection or semaglutide injection, including a dose-escalation period, a core treatment period and a treatment extension period, for up to 60 weeks.
Interventions
DRUGXW003 injection
Subcutaneous injection
Subcutaneous injection
Sponsors
Hangzhou Sciwind Biosciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* BMI≥30 kg/m2 at screening, waist circumference ≥90 cm for men and ≥85 cm for women. * Weight change of less than 5% within 3 months prior to screening (self-reported).
Exclusion criteria
* Diagnosis of obesity due to endocrine disorders or a single gene mutation, including but not limited to hypothalamic obesity, pituitary obesity, Cushing's syndrome, hypothyroidic obesity (except for those with normal thyroid function at screening and expected to remain unchanged throughout the trial period after at least 3 months of thyroid hormone replacement therapy), insulinoma, acromegaly. * History of bariatric surgery or planning to undergo bariatric surgery or use other weight-loss drugs or devices during the trial (except acupuncture for weight loss, liposuction, or abdominal fat removal for more than one year before screening; Except the removal or expulsion of the airbag in the stomach for more than 1 year before screening. * Diagnosis with any type of diabetes (except gestational diabetes). * Have used any weight-loss drugs, hypoglycemic drugs, or drugs that may cause significant weight gain within 3 months prior to screening. * History of acute or chronic pancreatitis or pancreatic injury, history of symptomatic gallbladder disease (except cholecystectomy). * History of clinically significant gastric emptying abnormalities, such as gastroparesis or gastric outlet obstruction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weight relative to baseline | week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Proportions of participants with weight loss ≥5% from baseline | week 48 |
| Proportions of participants with weight loss ≥10% from baseline | week 48 |
| Proportions of participants with weight loss ≥15% from baseline | week 48 |
| The change in waist circumference relative to the baseline | week 48 |
| Changes in body mass index (BMI) relative to baseline | week 48 |
Countries
China
Contacts
Primary ContactYao Li
Outcome results
None listed