Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-06 @ 5:21 AM
Study NCT ID:
NCT06948435
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729680', 'term': 'orforglipron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 487}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-04-21', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in office Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline to Week 36'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP', 'timeFrame': 'Baseline to Week 36'}, {'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Baseline to Week 36'}, {'measure': 'Percent Change from Baseline in Triglycerides', 'timeFrame': 'Baseline to Week 36'}, {'measure': 'Percent Change from Baseline in non-HDL Cholesterol', 'timeFrame': 'Baseline to Week 36'}, {'measure': 'Percent Change from Baseline in hsCRP Concentration (mg/L)', 'timeFrame': 'Baseline to Week 48'}, {'measure': 'Change in office SBP in Randomized Withdrawal Population', 'timeFrame': 'Week 48 to Week 60'}, {'measure': 'Pharmacokinetics (PK): Steady-State Area Under the Concentration Curve (AUC) of Orforglipron', 'timeFrame': 'Baseline to Week 36'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Overweight or Obesity']}, 'descriptionModule': {'briefSummary': 'GZL1 is an independent study conducted under the GZPL master protocol. GZL1 will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* refer to the GZPL master protocol for screening eligibility.\n\nExclusion Criteria:\n\n* refer to the GZPL master protocol for screening eligibility.'}, 'identificationModule': {'nctId': 'NCT06948435', 'briefTitle': 'A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Hypertension and Obesity or Overweight: Randomized, Double-Blind, Placebo-Controlled Trials (ATTAIN-HYPERTENSION)', 'orgStudyIdInfo': {'id': '27359'}, 'secondaryIdInfos': [{'id': 'J2A-MC-GZL1', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'J2A-MC-GZPL', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orforglipron', 'description': 'Participants will receive orforglipron orally.', 'interventionNames': ['Drug: Orforglipron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administered placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Orforglipron', 'type': 'DRUG', 'otherNames': ['LY3502970'], 'description': 'Administered orally', 'armGroupLabels': ['Orforglipron']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo administered.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph Lillo, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Elite Clinical Studies, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91723', 'city': 'Covina', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Fahed Bitar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Valley Clinical Trials, Inc.', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Chow', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Valley Clinical Trials, Inc.', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph Soufer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chase Medical Research, LLC', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '33434', 'city': 'Boca Raton', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Hafran', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Excel Medical Clinical Trials', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33510', 'city': 'Brandon', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Parenkumar Patel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Care Access - 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