Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT04720534
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2021-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic 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': 'ACTUAL', 'count': 229}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2024-03-08', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-01-19', 'dispFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change from Baseline in Fasting Triglycerides (TG) at Week 24', 'timeFrame': 'Baseline, Week 24'}], 'secondaryOutcomes': [{'measure': 'Percent Change from Baseline in Fasting TG Over Time Through Week 48', 'timeFrame': 'Baseline, up to Week 48'}, {'measure': 'Percent Change from Baseline in Apolipoprotein (Apo)C-III at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Percent Change from Baseline in ApoC-III Over Time Through Week 48', 'timeFrame': 'Baseline, up to Week 48'}, {'measure': 'Percent Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Percent Change from Baseline in Fasting Non-HDL-C Over Time Through Week 48', 'timeFrame': 'Baseline, up to Week 48'}, {'measure': 'Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Percent Change from Baseline in Fasting HDL-C Over Time Through Week 48', 'timeFrame': 'Baseline, up to Week 48'}, {'measure': 'Percent Change from Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Percent Change from Baseline in Fasting Total ApoB Over Time Through Week 48', 'timeFrame': 'Baseline, up to Week 48'}, {'measure': 'Percent Change from Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Percent Change from Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Through Week 48', 'timeFrame': 'Baseline, up to Week 48'}, {'measure': 'Change from Baseline in Plasma Concentration of ARO-APOC3 Over Time Through Week 48', 'timeFrame': 'Baseline, up to Week 48'}, {'measure': 'Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) Possibly or Probably Related to Treatment', 'timeFrame': 'up to Week 48'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Hypertriglyceridemia']}, 'referencesModule': {'references': [{'pmid': '38583092', 'type': 'DERIVED', 'citation': 'Gaudet D, Pall D, Watts GF, Nicholls SJ, Rosenson RS, Modesto K, San Martin J, Hellawell J, Ballantyne CM. Plozasiran (ARO-APOC3) for Severe Hypertriglyceridemia: The SHASTA-2 Randomized Clinical Trial. JAMA Cardiol. 2024 Jul 1;9(7):620-630. doi: 10.1001/jamacardio.2024.0959.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of AROAPOC3-2001 is to evaluate the efficacy and safety of ARO-APOC3 in participants with severe hypertriglyceridemia. Participants will receive 2 subcutaneous injections of ARO-APOC3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Based on medical history, evidence of TG ≥ 500 mg/dL and ≤ 4000 mg/dL at Screening\n* Fasting TG ≥ 500 mg/dL at Screening\n* Willing to follow diet counseling per Investigator judgment based on local standard of care\n* Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception\n* Willing to provide written informed consent and to comply with study requirements\n\nExclusion Criteria:\n\n* Active pancreatitis within 12 weeks prior to first dose\n* Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study\n* Acute coronary syndrome event within 24 weeks of first dose\n* Major surgery within 12 weeks of first dose\n* Planned coronary intervention (e.g., stent placement or heart bypass) or any non-cardiac major surgical procedure throughout the study\n* Uncontrolled hypertension\n* Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)\n* Uncontrolled hypothyroidism or hyperthyroidism\n* Hemorrhagic stroke within 24 weeks of first dose\n* Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)\n\nNote: additional inclusion/exclusion criteria may apply per protocol'}, 'identificationModule': {'nctId': 'NCT04720534', 'acronym': 'SHASTA-2', 'briefTitle': 'Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arrowhead Pharmaceuticals'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Severe Hypertriglyceridemia', 'orgStudyIdInfo': {'id': 'AROAPOC3-2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARO-APOC3 10 mg, Day 1 and Week 12', 'description': '2 doses of ARO-APOC3 by subcutaneous (sc) injection', 'interventionNames': ['Drug: ARO-APOC3']}, {'type': 'EXPERIMENTAL', 'label': 'ARO-APOC3 25 mg, Day 1 and Week 12', 'description': '2 doses of ARO-APOC3 by sc injection', 'interventionNames': ['Drug: ARO-APOC3']}, {'type': 'EXPERIMENTAL', 'label': 'ARO-APOC3 50 mg, Day 1 and Week 12', 'description': '2 doses of ARO-APOC3 by sc injection', 'interventionNames': ['Drug: ARO-APOC3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, Day 1 and Week 12', 'description': 'calculated volume to match active treatment by sc injection', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ARO-APOC3', 'type': 'DRUG', 'description': '2 doses of ARO-APOC3 by subcutaneous (sc) injection', 'armGroupLabels': ['ARO-APOC3 10 mg, Day 1 and Week 12', 'ARO-APOC3 25 mg, Day 1 and Week 12', 'ARO-APOC3 50 mg, Day 1 and Week 12']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'calculated volume to match active treatment by sc injection', 'armGroupLabels': ['Placebo, Day 1 and Week 12']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Research Site 2', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92292', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Research Site 4', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '33434', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 5', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 6', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 10', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 9', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 11', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 8', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33166', 'city': 'Miami Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 12', 'geoPoint': {'lat': 25.82232, 'lon': -80.2895}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 14', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '30338', 'city': 'Dunwoody', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site 16', 'geoPoint': {'lat': 33.94621, 'lon': -84.33465}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site 17', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Research Site 18', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site 20', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Research Site 21', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '59901', 'city': 'Kalispell', 'state': 'Montana', 'country': 'United States', 'facility': 'Research Site 22', 'geoPoint': {'lat': 48.19579, 'lon': -114.31291}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Research Site 23', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89121', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Research Site 24', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11106', 'city': 'Long Island City', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site 25', 'geoPoint': {'lat': 40.74482, 'lon': -73.94875}}, {'zip': '12553', 'city': 'New Windsor', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site 26', 'geoPoint': {'lat': 41.47676, 'lon': -74.02375}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site 27', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site 29', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Research Site 30', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45419', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site 31', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '45005', 'city': 'Franklin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site 32', 'geoPoint': {'lat': 39.55895, 'lon': -84.30411}}, {'zip': '43537', 'city': 'Maumee', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site 33', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '73135', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Research Site 34', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site 35', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site 36', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site 38', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77099', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site 39', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78249', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site 40', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '20110', 'city': 'Manassas', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site 41', 'geoPoint': {'lat': 38.75095, 'lon': -77.47527}}, {'zip': '6009', 'city': 'Perth', 'state': 'Nedlands', 'country': 'Australia', 'facility': 'Research Site 43', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Research Site 42', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '4064', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Research Site 44', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4556', 'city': 'Sippy Downs', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Research Site 45', 'geoPoint': {'lat': -26.71793, 'lon': 153.05475}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Research Site 46', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Research Site 47', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': 'L4K 4M2', 'city': 'Concord', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site 49', 'geoPoint': {'lat': 43.80011, 'lon': -79.48291}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site 50', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M4G 3E8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site 51', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G7H5H6', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site 52', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': 'J4V2G8', 'city': 'Greenfield', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site 53'}, {'zip': 'H2W2T2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site 54', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Research Site 55', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '0 4103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Research Site 56', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '6500', 'city': 'Baja', 'country': 'Hungary', 'facility': 'Research Site 57', 'geoPoint': {'lat': 46.18299, 'lon': 18.95307}}, {'zip': '6500', 'city': 'Baja', 'country': 'Hungary', 'facility': 'Research Site 58', 'geoPoint': {'lat': 46.18299, 'lon': 18.95307}}, {'zip': 'H-8230', 'city': 'Balatonföldvár', 'country': 'Hungary', 'facility': 'Research Site 59', 'geoPoint': {'lat': 46.85255, 'lon': 17.88123}}, {'zip': '5600', 'city': 'Békéscsaba', 'country': 'Hungary', 'facility': 'Research Site 60', 'geoPoint': {'lat': 46.68333, 'lon': 21.1}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Research Site 61', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '3200', 'city': 'Gyöngyös', 'country': 'Hungary', 'facility': 'Research Site 62', 'geoPoint': {'lat': 47.78257, 'lon': 19.928}}, {'zip': '2921', 'city': 'Komárom', 'country': 'Hungary', 'facility': 'Research Site 63', 'geoPoint': {'lat': 47.74318, 'lon': 18.11913}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Research Site 65', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '4405', 'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Research Site 64', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Research Site 66', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3318 AT', 'city': 'Dordrecht', 'country': 'Netherlands', 'facility': 'Research Site 67', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'zip': '08601', 'city': 'Sneek', 'country': 'Netherlands', 'facility': 'Research Site 68', 'geoPoint': {'lat': 53.03297, 'lon': 5.6589}}, {'zip': '1010', 'city': 'Grafton', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'Research Site 73', 'geoPoint': {'lat': -36.86029, 'lon': 174.76566}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Research Site 69', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '3200', 'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Research Site 70', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': '2025', 'city': 'Papatoetoe', 'country': 'New Zealand', 'facility': 'Research Site 71', 'geoPoint': {'lat': -36.9682, 'lon': 174.84019}}, {'zip': '3010', 'city': 'Rotorua', 'country': 'New Zealand', 'facility': 'Research Site 72', 'geoPoint': {'lat': -38.13874, 'lon': 176.24516}}, {'zip': '85-605', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Research Site 74', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '82-300', 'city': 'Elblag', 'country': 'Poland', 'facility': 'Research Site 75', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'zip': '81-157', 'city': 'Gdynia', 'country': 'Poland', 'facility': 'Research Site 76', 'geoPoint': {'lat': 54.51889, 'lon': 18.53188}}, {'zip': '94-048', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Research Site 83', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '32-600', 'city': 'Oświęcim', 'country': 'Poland', 'facility': 'Research Site 78', 'geoPoint': {'lat': 50.03437, 'lon': 19.21037}}, {'zip': '61-655', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Research Site 79', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '24-100', 'city': 'Puławy', 'country': 'Poland', 'facility': 'Research Site 80', 'geoPoint': {'lat': 51.41655, 'lon': 21.96939}}, {'zip': '35-055', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Research Site 81', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '05-200', 'city': 'Wołomin', 'country': 'Poland', 'facility': 'Research Site 82', 'geoPoint': {'lat': 52.34006, 'lon': 21.24207}}, {'zip': '99-100', 'city': 'Łęczyca', 'country': 'Poland', 'facility': 'Research Site 77', 'geoPoint': {'lat': 52.05959, 'lon': 19.19972}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arrowhead Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}