Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-30 @ 11:16 PM
Study NCT ID:
NCT05813795
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2023-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 664}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-04-12', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in body weight from baseline', 'timeFrame': 'Week 40'}, {'measure': 'Proportion of subjects with weight loss ≥5% from baseline', 'timeFrame': 'Week 40'}], 'secondaryOutcomes': [{'measure': 'Percent and absolute body weight change from baseline', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48'}, {'measure': 'Proportion of subjects with weight loss ≥ 5%, 10%, 15% from baseline', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48'}, {'measure': 'Change from baseline in BMI', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48', 'description': 'height will be only measured at baseline'}, {'measure': 'Change from baseline in waist and hip circumferences', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Weight management', 'overweight', 'obesity', 'glucagon-like peptide-1 (GLP-1)', 'ecnoglutide', 'XW003'], 'conditions': ['Weight Management']}, 'referencesModule': {'references': [{'pmid': '40555243', 'type': 'DERIVED', 'citation': 'Ji L, Gao L, Xue H, Tian J, Wang K, Jiang H, Huang C, Lian Q, Yuan M, Gao G, Lu Y, Han J, Fu W, Wang H, Zhang Y, Shi X, Wen B, Shi B, Hu W, Guo T, Xing Y, Li Y, Li Q, Zheng Q, Yang M, Ning J, Guo M, Li Y, Pan H. Efficacy and safety of a biased GLP-1 receptor agonist ecnoglutide in adults with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2025 Sep;13(9):777-789. doi: 10.1016/S2213-8587(25)00141-X. Epub 2025 Jun 21.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the efficacy and safety of XW003 versus placebo in adults with overweight or obesity', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, 18-75 years old, inclusive;\n2. 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.\n3. Weight change of no more than 5% (based on self-report), with diet and exercise alone, within 3 months before screening.\n4. Willing and able to maintain stable diet and exercise during the study period.\n\nExclusion Criteria:\n\n1. Obesity induced by endocrine diseases such as hypothyroidism, Cushing Syndrome, etc.\n2. History of bariatric surgery (except liposuction \\>1 year ago) or planned bariatric surgery during the study period.\n3. Within 3 months before screening, history of using the following drugs or treatments:\n\n 1. Any approved or unapproved weight-loss drugs or Chinese herbs or health products that affect body weight.\n 2. Any hypoglycemic medication.\n 3. Any medication that may cause significant weight gain, including systemic glucocorticoid treatment, tricyclic anti-depressants, anti-epileptic and antipsychotics.\n 4. Any investigational drug, vaccine, or medical device.'}, 'identificationModule': {'nctId': 'NCT05813795', 'briefTitle': 'A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hangzhou Sciwind Biosciences Co., Ltd.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'SCW0502-1131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C1- XW003 Low Dosage', 'description': 'XW003 with low dosage once weekly', 'interventionNames': ['Drug: Ecnoglutide Low Dosage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C1-Placebo', 'description': 'Matched Placebo once weekly', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'C2- XW003 Medium Dosage', 'description': 'XW003 with medium dosage once weekly', 'interventionNames': ['Drug: Ecnoglutide Medium Dosage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C2-Placebo', 'description': 'Matched Placebo once weekly', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'C3- XW003 High Dosage', 'description': 'XW003 with high dosage once weekly', 'interventionNames': ['Drug: Ecnoglutide High Dosage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C3-Placebo', 'description': 'Matched Placebo once weekly', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ecnoglutide Low Dosage', 'type': 'DRUG', 'otherNames': ['XW003'], 'description': 'Subcutaneous Injection', 'armGroupLabels': ['C1- XW003 Low Dosage']}, {'name': 'Ecnoglutide Medium Dosage', 'type': 'DRUG', 'otherNames': ['XW003'], 'description': 'Subcutaneous Injection', 'armGroupLabels': ['C2- XW003 Medium Dosage']}, {'name': 'Ecnoglutide High Dosage', 'type': 'DRUG', 'otherNames': ['XW003'], 'description': 'Subcutaneous Injection', 'armGroupLabels': ['C3- XW003 High Dosage']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutaneous Injection with matched volume', 'armGroupLabels': ['C1-Placebo', 'C2-Placebo', 'C3-Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Linong Ji, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangzhou Sciwind Biosciences Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}