Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT07139535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-24
First Post:
2025-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of RAY1225 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-17', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-08-17', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline,36 Week', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving an HbA1c Target Value of <7%', 'timeFrame': 'Baseline,36 Week'}, {'measure': 'Percentage of Participants With HbA1c Target Value of <6.5%', 'timeFrame': 'Baseline,36 Week'}, {'measure': 'Mean change in fasting serum glucose', 'timeFrame': 'Baseline,36 Week'}, {'measure': 'Proportion of patients who achieved weight loss of >5%, >10%, and >15% from baseline', 'timeFrame': 'Baseline,36 Week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['T2DM']}, 'descriptionModule': {'briefSummary': 'The goal for this study is to evaluate the efficacy and safety of RAY1225 versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Have been diagnosed with type 2 diabetes mellitus (T2DM)\n2. Having received only dietary and exercise therapy and never taken any antihyperglycemic medications before screening; OR Having taken no antihyperglycemic medications within the 12 weeks before screening and, prior to that, having received only oral antihyperglycemic drugs in a regimen of no more than two concomitant agents.\n3. Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening\n4. Be of stable weight (±5%) for at least 12 weeks before screening\n\nExclusion Criteria:\n\n1. Have type 1 diabetes mellitus\n2. Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;\n3. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;\n4. Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose \\<3.0 mmol/L) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;\n5. History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;\n6. Receipt of blood transfusion within 12 weeks prior to screening, or blood donation/loss ≥400 mL within 12 weeks prior to screening, or blood donation/loss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.);\n7. Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.)."}, 'identificationModule': {'nctId': 'NCT07139535', 'briefTitle': 'A Study of RAY1225 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong Raynovent Biotech Co., Ltd'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of RAY1225 Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone', 'orgStudyIdInfo': {'id': 'RAY1225-24-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3mg RAY1225', 'description': 'Participants received 3 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.', 'interventionNames': ['Drug: RAY1225']}, {'type': 'EXPERIMENTAL', 'label': '6mg RAY1225', 'description': 'Participants received 6 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.', 'interventionNames': ['Drug: RAY1225']}, {'type': 'EXPERIMENTAL', 'label': '9mg RAY1225', 'description': 'Participants received 9 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.', 'interventionNames': ['Drug: RAY1225']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo as subcutaneous injection once every two week.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'RAY1225', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['3mg RAY1225', '6mg RAY1225', '9mg RAY1225']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijingcun', 'state': 'Hebei', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 41.26103, 'lon': 119.10946}}], 'centralContacts': [{'name': 'JI professor', 'role': 'CONTACT', 'email': 'iao@pkuph.edu.cn', 'phone': '88326666'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Raynovent Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}