Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-09 @ 12:33 PM
Study NCT ID:
NCT07060456
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-06-22', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'from baseline to Week 40', 'description': 'Change in HbA1c after 40 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects reaching HbA1<7.0%', 'timeFrame': 'from baseline to Week 40', 'description': 'Proportion of subjects reaching HbA1\\<7.0% after 40 weeks of treatment.'}, {'measure': 'Proportion of subjects reaching HbA1≤6.5%', 'timeFrame': 'from baseline to Week 40', 'description': 'Proportion of subjects reaching HbA1≤6.5% after 40 weeks of treatment.'}, {'measure': 'Change in FPG', 'timeFrame': 'from baseline to Week 40', 'description': 'Change in FPG after 40 weeks of treatment.'}, {'measure': 'Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score', 'timeFrame': 'From baseline to Week 40', 'description': 'Change from baseline in DTSQs after 40 weeks of treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, able and willing to provide a written informed consent\n2. Diagnosed with type 2 diabetes ≥ 90 days；\n3. On stable once-daily dose of basal insulin alone or in combination with metformin and/or SGLT2 inhibitor ≥ 90 days;\n4. HbA1c was 7.5%\\~11.0% (both inclusive);\n5. Body Mass Index (BMI) ≥22 kg/m2 at screening.\n\nExclusion Criteria:\n\n1. A history of type 1 diabetes, specific diabetes, or secondary diabetes;\n2. Have a history of severe hypoglycemia within t180 days prior to screening;\n3. History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening；\n4. Have a history of malignancy within 5 years;\n5. Known or suspected allergy or intolerance to the investigational medicinal products or related products;\n6. Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 90 days;\n7. Any conditions that the Investigator judges might not be suitable to participate in the trial.'}, 'identificationModule': {'nctId': 'NCT07060456', 'briefTitle': 'Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fujian Shengdi Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.', 'orgStudyIdInfo': {'id': 'HRS9531-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A: HRS9531-low dose', 'interventionNames': ['Drug: HRS9531']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group B: HRS9531-high dose', 'interventionNames': ['Drug: HRS9531']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment group C', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HRS9531', 'type': 'DRUG', 'description': 'HRS9531-low dose', 'armGroupLabels': ['Treatment group A: HRS9531-low dose']}, {'name': 'HRS9531', 'type': 'DRUG', 'description': 'HRS9531-high dose', 'armGroupLabels': ['Treatment group B: HRS9531-high dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Treatment group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Linong JI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Perking University Peoples' Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hong Chen', 'role': 'CONTACT', 'email': 'hong.chen@hengrui.com', 'phone': '+86-0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Shengdi Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}