Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 3:13 AM
Study NCT ID:
NCT07352969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Finding Study of IBI3016 in Mild to Moderate Hypertensive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 352}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2029-03-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2026-01-13', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in SBP by OBPM', 'timeFrame': 'From baseline through month 3', 'description': 'Change from baseline at Month 3 in systolic blood pressure (SBP) by office blood pressure measurement (OBPM)'}], 'secondaryOutcomes': [{'measure': 'Change in Mean 24hr SBP by ABPM', 'timeFrame': 'From baseline through month 3', 'description': 'Change from baseline at Month 3 in mean 24hr SBP by ambulatory blood pressure measurement (ABPM)'}, {'measure': 'Change in SBP and DBP by OBPM', 'timeFrame': 'From baseline through month 6', 'description': 'Change from baseline through month 6 in SBP and diastolic blood pressure (DBP) by OBPM'}, {'measure': 'Change in Mean 24hr, mean daytime, mean nighttime SBP and DBP by ABPM', 'timeFrame': 'Change from baseline through month 6 in Mean 24hr, mean daytime, mean nighttime SBP and DBP by OBPM', 'description': 'From baseline through month 6'}, {'measure': 'Percentage Change in AGT by blood test', 'timeFrame': 'From baseline through month 24', 'description': 'Percentage Change from baseline through month 24 in Angiotensinogen (AGT) by blood test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety and tolerability of IBI3016 or placebo, given subcutaneously, every 3 or 6 months, at different dose levels in patients with mild to moderate hypertension', 'detailedDescription': 'Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and pharmacodynamics of IBI3016 in patients with mild to moderate hypertension. Multiple doses of IBI3016 will be tested against placebo, administered as subcutaneous injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent.\n2. Males or females aged 18 to 75 years.\n3. Diagnosis of primary hypertension without anti-HTN medication or with one anti-HTN medication\n4. Mean sitting SBP ≥140 mmHg and \\< 170 mmHg measured by OBPM.\n5. Participants able to understand and comply with study procedures.\n\nExclusion Criteria:\n\n1. Known history of secondary hypertension.\n2. Orthostatic hypotension.\n3. Laboratory parameter assessments outside of range at screening：\n\n * Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \\> 2× Upper Limit of Normal (ULN)\n * Total Bilirubin \\> 1.5× ULN\n * International Normalized Ratio (INR) \\> 2.0\n * Serum Potassium \\> 5 mg/L\n * Estimated Glomerular Filtration Rate (eGFR) ≤ 45 mL/min/1.73m²\n * QTcF \\> 480 ms\n4. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.\n5. Current or history of intolerance to ACEi and/or ARBs.\n6. Acute myocardial infarction (AMI), unstable angina, percutaneous coronary intervention (PCI) , coronary artery bypass graft (CABG), ischemic or hemorrhagic stroke, transient ischemic attack, or clinically significant cardiac arrhythmias within 6 months prior to screening. Any history of congestive heart failure.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT07352969', 'briefTitle': 'A Dose Finding Study of IBI3016 in Mild to Moderate Hypertensive Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovent Biologics (Suzhou) Co. Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multicenter, 24 Months Treatment Duration, Dose Finding Study, to Evaluate Efficacy, Safety and Pharmacodynamics of IBI3016 in Mild to Moderate Hypertensive Patients', 'orgStudyIdInfo': {'id': 'CIBI3016A201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IBI3016 dose 4', 'description': 'subcutaneous injection', 'interventionNames': ['Drug: IBI3016']}, {'type': 'EXPERIMENTAL', 'label': 'IBI3016 dose 1', 'description': 'subcutaneous injection', 'interventionNames': ['Drug: IBI3016']}, {'type': 'EXPERIMENTAL', 'label': 'IBI3016 dose 2', 'description': 'subcutaneous injection', 'interventionNames': ['Drug: IBI3016']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'subcutaneous injection', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'IBI3016 dose 3', 'description': 'subcutaneous injection', 'interventionNames': ['Drug: IBI3016']}, {'type': 'EXPERIMENTAL', 'label': 'IBI3016 dose 5', 'description': 'subcutaneous injection', 'interventionNames': ['Drug: IBI3016']}], 'interventions': [{'name': 'IBI3016', 'type': 'DRUG', 'description': 'Solution of Injection', 'armGroupLabels': ['IBI3016 dose 1', 'IBI3016 dose 2', 'IBI3016 dose 3', 'IBI3016 dose 4', 'IBI3016 dose 5']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '0.9% sodium chloride saline solution', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Jun Cai', 'role': 'CONTACT', 'email': 'caijun7879@126.com', 'phone': '010-81992130'}, {'name': 'Jun Cai', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Anzhen Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jinling Fan', 'role': 'CONTACT', 'email': 'jinling.fan@innoventbio.com', 'phone': '0512-69566088'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovent Biologics (Suzhou) Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}