Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}, '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': 1205}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-10-30', 'studyFirstSubmitQcDate': '2025-10-30', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change from Baseline in Maximum Walking Distance', 'timeFrame': 'Baseline, Week 52', 'description': 'On a constant load treadmill test'}], 'secondaryOutcomes': [{'measure': 'Percent Change from Baseline in Pain Free Walking Distance', 'timeFrame': 'Baseline, Week 52', 'description': 'On a constant load treadmill test'}, {'measure': 'Change from Baseline in Vascular Quality of Life (VascuQoL-6) Questionnaire Score', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Change from Baseline in 6 Minute Walk Test Distance (meters)', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Change from Baseline in Systolic Blood Pressure (mmHg)', 'timeFrame': 'Baseline, Week 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/663317', 'label': 'Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease (ATTAIN-PAD)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have symptomatic PAD with intermittent claudication of Fontaine Stage II\n* Have an Ankle Brachial Index (ABI) of 0.9 or less\n\nExclusion Criteria:\n\n* Have a body mass index (BMI) less than 23 kilogram per square meter (kg/m2)\n* Have Hemoglobin A1c (HbA1c) greater than 10%\n* Have walking ability limited by conditions other than PAD\n* Have a planned lower limb surgery or any other surgery affecting walking ability\n* Had peripheral revascularization procedure within 90 days prior to the day of screening or planning to undergo peripheral revascularization during the clinical trial\n* Had stroke, transient ischemic attack, myocardial infarction, coronary or carotid revascularization, or hospitalization for unstable angina pectoris within 60 days prior to screening\n* Have heart failure presently classified as being in New York Heart Association class III - IV'}, 'identificationModule': {'nctId': 'NCT07223593', 'acronym': 'ATTAIN-PAD', 'briefTitle': 'Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Peripheral Artery Disease: A Randomized, Double-Blind, Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '27632'}, 'secondaryIdInfos': [{'id': '2025-523283-21-00', 'type': 'CTIS'}, {'id': 'J2A-MC-GZPR', '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': 'Participants will receive placebo orally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Orforglipron', 'type': 'DRUG', 'otherNames': ['LY3502970'], 'description': 'Administered orally', 'armGroupLabels': ['Orforglipron']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher DeGroat', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Vincent's Birmingham Hospital", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85297', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '602-214-0886'}, {'name': 'Nabil Dib, MD, Msc,', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mercy Gilbert Medical Center', 'geoPoint': 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'Taoyuan District', 'status': 'NOT_YET_RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Pao-Hsien Chu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chang Gung Medical Foundation-Linkou Branch', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Patrick Coughlin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Leeds General Infirmary', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'W6 8RF', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Alun Davies', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Imperial College Healthcare NHS Trust, Charing Cross Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'Pl6 8DH', 'city': 'Plymouth', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'role': 'CONTACT', 'phone': '01752431822'}, {'name': 'Devender Mittapalli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'ST4 6QG', 'city': 'Stoke-on-Trent', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Arun Pherwani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Stoke University Hospital', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'zip': 'SA2 8PP', 'city': 'Swansea', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'role': 'CONTACT', 'phone': '07710641345'}, {'name': 'Stephen Bain', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Swansea University', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}, {'zip': 'SO30 3JB', 'city': 'West End', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Sarah Brewster', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Moorgreen Hospital', 'geoPoint': {'lat': 51.51235, 'lon': -0.14358}}], 'centralContacts': [{'name': 'Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or', 'role': 'CONTACT', 'email': 'LillyTrials@Lilly.com', 'phone': '317-615-4559'}, {'name': 'Physicians interested in becoming principal investigators please contact', 'role': 'CONTACT', 'email': 'clinical_inquiry_hub@lilly.com'}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. 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