Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
Study NCT ID:
NCT06118008
Status:
COMPLETED
Last Update Posted:
2025-08-03
First Post:
2023-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of HS-20094 in T2DM Participants
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2023-05-25', 'studyFirstSubmitQcDate': '2023-11-03', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug', 'timeFrame': 'From Baseline to Day 57.', 'description': 'A summary of AEs and SAEs, AE leading to study discontinuation, AE severity and relation with study drug will be reported in the reported adverse events module'}, {'measure': 'The number of participants with changes of laboratory tests blood routine, urine routine, blood biochemistry, coagulation function', 'timeFrame': 'From Baseline to Day 57'}, {'measure': 'The changes ECG examination assessed by PR, R-R, QRS and QTcF', 'timeFrame': 'From Baseline to Day 57', 'description': '12-lead electrocardiogram (ECG) parameters'}, {'measure': 'The changes in Blood pressure', 'timeFrame': 'From Baseline to Day 57', 'description': 'Vital signs'}, {'measure': 'Pulse rate', 'timeFrame': 'From Baseline to Day 57', 'description': 'Vital signs'}, {'measure': 'Respiratory rate', 'timeFrame': 'From Baseline to Day 57', 'description': 'Vital signs'}, {'measure': 'Temperature', 'timeFrame': 'From Baseline to Day 57', 'description': 'Vital signs'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Cmax of HS-20094', 'timeFrame': 'Baseline to Day 57', 'description': 'PK: Cmax of HS-20094'}, {'measure': 'Pharmacokinetics (PK): Tmax of HS-20094', 'timeFrame': 'Baseline to Day 57', 'description': 'PK: Tmax of HS-20094'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094', 'timeFrame': 'Baseline to Day 57', 'description': 'PK: AUC of HS-20094'}, {'measure': 'Pharmacodynamics (PD): HbA1c', 'timeFrame': 'Baseline to Day 29', 'description': 'PD: change of HbA1c'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This is a randomized, placebo and active-control, multiple-dose, phase IIa trial. Patients were randomly assigned to receive HS-20094 (12 patients), placebo (3 patients), or active control drug Semaglutide injection (3 patients) in a 4:1:1 ratio to each of four dose cohorts of 5 mg, 10 mg, 15 mg, and 20 mg. HS-20094 and placebo were administered in a double-blind design by subcutaneous injection once a week for a total of four times, and the dose was gradually increased weekly (2.5-2.5-5-5 mg, 5-510-10 mg, 5-10-15-15 mg, 5-10-15-20 mg). The active control drug semaglutide was administered by open-label, titrated subcutaneous injection once a week for a total of four times, and the dose was increased gradually every week until 1.0 mg (0.25-0.5-0.5-1.0 mg). The primary study objective was to 1) Evaluate the safety and tolerability of multiple subcutaneous injections of HS-20094 in subjects with type 2 diabetes mellitus (T2DM) with or without overweight or obesity;2) Evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of multiple subcutaneous injections of HS-20094.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects,20-65 years of age at the time of signing informed consent.\n* Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit.\n* Treated with conventional lifestyle intervention and stable treatment with metformin ( ≥ 1000 mg/day) at least 3 months prior to screening HbA1c 7.5-10%(both inclusive)at screening visit.\n\nExclusion Criteria:\n\n* A history of type 1 diabetes, specific diabetes, or secondary diabetes.\n* Presence of-clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit.\n* Acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening.\n* A history of grade 2 hypoglycemia(blood glucose 3.0 mmol/L)or grade 3 hypoglycemia(hypoglycemia with a serious event of consciousness and/or physical alteration requiring assistance from another person for recovery)within 6 months before screening.\n* Diabetid ketoacidosis or hyperosmolar coma or lactic acidosis requiring hospitalization occurred within 6 months before screening.\n* Severe infection such as diabetic foot infection, pneumonia, or sepsis within 30 days before screening.\n* Uncontrollable hypertension.\n* History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.\n* Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.\n* Pregnant or lactating woman.\n* In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results."}, 'identificationModule': {'nctId': 'NCT06118008', 'briefTitle': 'A Study of HS-20094 in T2DM Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Hansoh Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multiple-dose, Randomized, Double-blind, Placebo and Positive Controlled Phase IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20094 in Subjects With Type 2 Diabetes.', 'orgStudyIdInfo': {'id': 'HS-20094-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HS-20094 5mg', 'description': 'Drug: HS-20094 Administrated by subcutaneous injection\n\nDrug: Placebo Administrated by subcutaneous injection\n\nDrug: Semaglutide Administrated by subcutaneous injection', 'interventionNames': ['Drug: HS-20094 5mg']}, {'type': 'EXPERIMENTAL', 'label': 'HS-20094 10mg', 'description': 'Drug: HS-20094 Administrated by subcutaneous injection\n\nDrug: Placebo Administrated by subcutaneous injection\n\nDrug: Semaglutide Administrated by subcutaneous injection', 'interventionNames': ['Drug: HS-20094 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'HS-20094 15mg', 'description': 'Drug: HS-20094 Administrated by subcutaneous injection\n\nDrug: Placebo Administrated by subcutaneous injection\n\nDrug: Semaglutide Administrated by subcutaneous injection', 'interventionNames': ['Drug: HS-20094 15mg']}, {'type': 'EXPERIMENTAL', 'label': 'HS-20094 20mg', 'description': 'Drug: HS-20094 Administrated by subcutaneous injection\n\nDrug: Placebo Administrated by subcutaneous injection\n\nDrug: Semaglutide Administrated by subcutaneous injection', 'interventionNames': ['Drug: HS-20094 20mg']}], 'interventions': [{'name': 'HS-20094 5mg', 'type': 'DRUG', 'otherNames': ['HS-20094 injection 5mg'], 'description': 'Administrated by subcutaneous injection', 'armGroupLabels': ['HS-20094 5mg']}, {'name': 'HS-20094 10mg', 'type': 'DRUG', 'otherNames': ['HS-20094 injection 10mg'], 'description': 'Administrated by subcutaneous injection', 'armGroupLabels': ['HS-20094 10mg']}, {'name': 'HS-20094 15mg', 'type': 'DRUG', 'otherNames': ['HS-20094 injection 15mg'], 'description': 'Administrated by subcutaneous injection', 'armGroupLabels': ['HS-20094 15mg']}, {'name': 'HS-20094 20mg', 'type': 'DRUG', 'otherNames': ['HS-20094 injection 20mg'], 'description': 'Administrated by subcutaneous injection', 'armGroupLabels': ['HS-20094 20mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Hansoh Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}