Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:51 AM
Study NCT ID:
NCT07387094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-04
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-12-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-28', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-01-28', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Apnea-Hypopnea Index (AHI)', 'timeFrame': 'at week 48'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in AHI', 'timeFrame': 'at week 48'}, {'measure': 'Percentage of Participants With ≥50% AHI Reduction From Baseline', 'timeFrame': 'at week 48'}, {'measure': 'Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10', 'timeFrame': 'at week 48'}, {'measure': 'Percent Change From Baseline in Body Weight', 'timeFrame': 'at week 48'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['XW003', 'Ecnoglutide', 'Obesity', 'OSA', 'GLP-1'], 'conditions': ['OSA - Obstructive Sleep Apnea', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the efficacy and safety of XW003 injections in obese participants with OSA but not receiving PAP', 'detailedDescription': 'In this Phase III 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 placebo, including a dose-escalation period, for up to 48 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Body mass index (BMI) ≥ 28.0 kg/m2;\n2. The results of PSG meet the diagnosis criteria of OSA and with an AHI ≥15 at screening;\n3. Participants must not have used PAP for at least 4 weeks prior to screening and not use PAP during the study;\n4. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.\n\nExclusion Criteria:\n\n1. History of endocrine disorders which have significant impact on body weight;\n2. Diagnosis of diabetes (except gestational diabetes), ketoacidosis or hypertonic state/coma;\n3. HbA1c ≥6.5% at screening;\n4. Fasting blood glucose ≥7.0 mmol/L or 2-hour blood glucose ≥11.1 mmol/L after oral glucose tolerance test (OGTT) at screening; participants with FBG ≥6.1 mmol/L but \\<7.0 mmol/L require OGTT;\n5. Have diagnosis of Cheyne Stokes Respiration, or diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%;\n6. Respiratory and neuromuscular diseases that could interfere with the results of the trial;\n7. Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia;\n8. Change of body weight \\>5% within 3 months prior to screening (self-reported);\n9. Have a prior or planned surgical treatment for obesity (except liposuction or abdominoplasty if performed more than 1 year prior to screening);\n10. Have received any medication for body weight loss and blood glucose lowering or medication that could lead to significant body weight increase, within 3 months prior to screening.'}, 'identificationModule': {'nctId': 'NCT07387094', 'briefTitle': 'A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hangzhou Sciwind Biosciences Co., Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy and Safety of XW003 Injections in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy', 'orgStudyIdInfo': {'id': 'SCW0502-5031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XW003 Injection', 'description': 'once weekly', 'interventionNames': ['Drug: XW003 injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'once weekly', 'interventionNames': ['Drug: placebo with matching volume']}], 'interventions': [{'name': 'XW003 injection', 'type': 'DRUG', 'description': 'subcutaneous injection', 'armGroupLabels': ['XW003 Injection']}, {'name': 'placebo with matching volume', 'type': 'DRUG', 'description': 'subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', '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'}}}}