Clinical trial
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)
Name
SCW0502-1131
Description
The aim of the study is to evaluate the efficacy and safety of XW003 versus placebo in adults with overweight or obesity
Trial arms
Trial start
2023-04-05
Estimated PCD
2025-01-22
Trial end
2025-01-22
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Ecnoglutide Low Dosage
Subcutaneous Injection
Arms:
C1- XW003 Low Dosage
Other names:
XW003
Ecnoglutide Medium Dosage
Subcutaneous Injection
Arms:
C2- XW003 Medium Dosage
Other names:
XW003
Ecnoglutide High Dosage
Subcutaneous Injection
Arms:
C3- XW003 High Dosage
Other names:
XW003
Placebo
Subcutaneous Injection with matched volume
Arms:
C1-Placebo, C2-Placebo, C3-Placebo
Size
664
Primary endpoint
Percent change in body weight from baseline
Week 40
Proportion of subjects with weight loss ≥5% from baseline
Week 40
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 664, 'type': 'ACTUAL'}}
Updated at
2023-07-17
1 organization
2 products
1 indication
Product
EcnoglutideIndication
Weight ManagementOrganization
Hangzhou Sciwind BiosciencesProduct
Placebo