Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-31 @ 3:53 AM
Study NCT ID:
NCT04048135
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2019-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bio89-100-002@89bio.com', 'phone': '1-858-261-8838', 'title': 'Clinical Director', 'organization': '89bio, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected after dosing to end of study (up to 113 days for Part 1 and up to 162 days for Part 2).', 'description': 'The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis.\n\nMedDRA version 23.0 was used for Part 1 and MedDRA version 23.1 was used for Part 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 7, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 8, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Part 1: Placebo QW or Q2W', 'description': 'Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 8, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part 2: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 18, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Bundle Branch Block Left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Thyroid Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Eye Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Abdominal Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Change of Bowel Habit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Epigastric Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Frequent Bowel Movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Gastrointestinal Sounds Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Swollen Tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Injection Site Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 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{'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Pulmonary Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Drug Eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0 and 23.1'}], 'seriousEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Number of Participants With Treatment-emergent Adverse Event (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG006', 'title': 'Part 1: Placebo QW or Q2W', 'description': 'Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 113 days', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were defined as AEs occurring at or after the first dose date and time, through study termination, or existing prior to the time of and worsening after the time of the first dose of investigational product. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis.'}, {'type': 'PRIMARY', 'title': 'Part 2: Number of Participants With TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 162 days', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were defined as AEs occurring at or after the first dose date and time, through study termination, or existing prior to the time of and worsening after the time of the first dose of investigational product. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set included all enrolled participants in Part 2 who received at least 1 dose of study intervention.'}, {'type': 'PRIMARY', 'title': 'Part 1: Maximum Observed Serum Concentration (Cmax) of Pegozafermin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '156'}, {'value': '439', 'groupId': 'OG001', 'lowerLimit': '238', 'upperLimit': '852'}, {'value': '901', 'groupId': 'OG002', 'lowerLimit': '200', 'upperLimit': '1281'}, {'value': '1166', 'groupId': 'OG003', 'lowerLimit': '566', 'upperLimit': '2243'}, {'value': '649', 'groupId': 'OG004', 'lowerLimit': '160', 'upperLimit': '1300'}, {'value': '1674', 'groupId': 'OG005', 'lowerLimit': '1300', 'upperLimit': '2791'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose and up to 168 hours postdose on Day 29', 'unitOfMeasure': 'ng/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis set included all randomized participants who received at least 1 dose of study intervention and had at least 1 on-study PK measurement.'}, {'type': 'PRIMARY', 'title': 'Part 1: Area Under the Serum Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Pegozafermin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}], 'classes': [{'categories': [{'measurements': [{'value': '11879', 'groupId': 'OG000', 'lowerLimit': '7350', 'upperLimit': '17778'}, {'value': '42576', 'groupId': 'OG001', 'lowerLimit': '24394', 'upperLimit': '70300'}, {'value': '95765', 'groupId': 'OG002', 'lowerLimit': '24822', 'upperLimit': '138904'}, {'value': '112632', 'groupId': 'OG003', 'lowerLimit': '57880', 'upperLimit': '231937'}, {'value': '78761', 'groupId': 'OG004', 'lowerLimit': '20520', 'upperLimit': '155994'}, {'value': '209436', 'groupId': 'OG005', 'lowerLimit': '153404', 'upperLimit': '287414'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose and up to 168 hours postdose on Day 29', 'unitOfMeasure': 'ng*hour/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis set included all randomized participants who received at least 1 dose of study intervention and had at least 1 on-study PK measurement.'}, {'type': 'PRIMARY', 'title': 'Part 1: Time to Peak Serum Concentration (Tmax) of Pegozafermin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '72.0'}, {'value': '48.0', 'groupId': 'OG001', 'lowerLimit': '18.6', 'upperLimit': '58.8'}, {'value': '48.0', 'groupId': 'OG002', 'lowerLimit': '34.7', 'upperLimit': '72.1'}, {'value': '48.1', 'groupId': 'OG003', 'lowerLimit': '46.3', 'upperLimit': '63.4'}, {'value': '72.0', 'groupId': 'OG004', 'lowerLimit': '47.5', 'upperLimit': '95.2'}, {'value': '48.0', 'groupId': 'OG005', 'lowerLimit': '45.2', 'upperLimit': '71.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose and up to 168 hours postdose on Day 29', 'unitOfMeasure': 'hr', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis set included all randomized participants who received at least 1 dose of study intervention and had at least 1 on-study PK measurement.'}, {'type': 'PRIMARY', 'title': 'Part 1: Terminal Elimination Half-life (t1/2) of Pegozafermin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '54.0', 'upperLimit': '75.3'}, {'value': '46.3', 'groupId': 'OG001', 'lowerLimit': '36.1', 'upperLimit': '67.7'}, {'value': '68.1', 'groupId': 'OG002', 'lowerLimit': '50.8', 'upperLimit': '114.0'}, {'value': '53.0', 'groupId': 'OG003', 'lowerLimit': '27.9', 'upperLimit': '62.2'}, {'value': '54.4', 'groupId': 'OG004', 'lowerLimit': '45.5', 'upperLimit': '70.4'}, {'value': '53.2', 'groupId': 'OG005', 'lowerLimit': '37.4', 'upperLimit': '62.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose and up to 168 hours postdose on Day 29', 'unitOfMeasure': 'hr', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis set included all randomized participants who received at least 1 dose of study intervention and had at least 1 on-study PK measurement.'}, {'type': 'PRIMARY', 'title': 'Part 2: Number of Participants With at Least a 2-point Improvement in NAFLD Activity Score (NAS) With at Least a 1-point Improvement in Ballooning or Lobular Inflammation, and no Worsening of Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 141', 'description': 'NAS was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranges from of 0 to 8, with higher scores indicating worse disease severity.\n\nWorsening of fibrosis was defined as progression of fibrosis ≥1 stage in NASH Clinical Research Network (CRN) fibrosis score.\n\nNASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Histology Biopsy Analysis Set included all enrolled participants who received at least 1 dose of study intervention and who had both baseline (screening or eligible historical) and post-baseline biopsies.'}, {'type': 'SECONDARY', 'title': 'Part 1: Number of Participants With a Positive Anti-Drug Antibodies (ADA) Response to Pegozafermin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG006', 'title': 'Part 1: Placebo QW or Q2W', 'description': 'Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 113 days', 'description': 'Number of participants with anti-pegozafermin antibodies (ADA) with status as ADA positive has been reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis set included all randomized participants who received at least 1 dose of study intervention. Arm groups were based upon the actual treatment received for the purpose of safety analysis.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percent Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG006', 'title': 'Part 1: Placebo QW or Q2W', 'description': 'Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG007', 'title': 'Part 2: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.19', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '2.47', 'spread': '0.79', 'groupId': 'OG002'}, {'value': '-0.80', 'spread': '0.86', 'groupId': 'OG003'}, {'value': '2.11', 'spread': '0.69', 'groupId': 'OG004'}, {'value': '2.64', 'spread': '0.86', 'groupId': 'OG005'}, {'value': '1.38', 'spread': '0.59', 'groupId': 'OG006'}, {'value': '-3.10', 'spread': '0.83', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Part 1: Baseline, Day 85; Part 2: Baseline, Day 141', 'description': 'Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM).', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis set included all randomized participants who received at least 1 dose of study intervention and who had measurable post-baseline PD data in Parts 1 and 2. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percent Change From Baseline in Triglycerides, High Density Lipoprotein (HDL) Cholesterol (c), Non-HDLc, LDLc, Hemoglobin (HbA1C), Alanine Transaminase, Aspartate Aminotransferase, N-terminal Propeptide of Type III Collagen (Pro-C3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG006', 'title': 'Part 1: Placebo QW or Q2W', 'description': 'Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG007', 'title': 'Part 2: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.'}], 'classes': [{'title': 'Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-22.74', 'spread': '11.53', 'groupId': 'OG000'}, {'value': '-23.95', 'spread': '7.74', 'groupId': 'OG001'}, {'value': '-17.71', 'spread': '8.20', 'groupId': 'OG002'}, {'value': '-27.63', 'spread': '9.66', 'groupId': 'OG003'}, {'value': '-28.49', 'spread': '8.62', 'groupId': 'OG004'}, {'value': '-20.71', 'spread': '9.74', 'groupId': 'OG005'}, {'value': '-2.21', 'spread': '6.23', 'groupId': 'OG006'}, {'value': '-25.30', 'spread': '5.66', 'groupId': 'OG007'}]}]}, {'title': 'HDLc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '18.17', 'spread': '5.43', 'groupId': 'OG000'}, {'value': '11.19', 'spread': '3.68', 'groupId': 'OG001'}, {'value': '9.20', 'spread': '3.92', 'groupId': 'OG002'}, {'value': '2.90', 'spread': '4.50', 'groupId': 'OG003'}, {'value': '20.10', 'spread': '3.73', 'groupId': 'OG004'}, {'value': '9.79', 'spread': '4.56', 'groupId': 'OG005'}, {'value': '1.96', 'spread': '2.97', 'groupId': 'OG006'}, {'value': '22.65', 'spread': '5.58', 'groupId': 'OG007'}]}]}, {'title': 'Non HDLc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-6.31', 'spread': '6.45', 'groupId': 'OG000'}, {'value': '-13.87', 'spread': '4.61', 'groupId': 'OG001'}, {'value': '-1.92', 'spread': '4.74', 'groupId': 'OG002'}, {'value': '-16.32', 'spread': '5.51', 'groupId': 'OG003'}, {'value': '-7.75', 'spread': '4.38', 'groupId': 'OG004'}, {'value': '-6.34', 'spread': '5.39', 'groupId': 'OG005'}, {'value': '1.18', 'spread': '3.56', 'groupId': 'OG006'}, {'value': '-17.12', 'spread': '3.53', 'groupId': 'OG007'}]}]}, {'title': 'LDLc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-6.17', 'spread': '7.38', 'groupId': 'OG000'}, {'value': '-13.45', 'spread': '5.29', 'groupId': 'OG001'}, {'value': '2.59', 'spread': '5.41', 'groupId': 'OG002'}, {'value': '-16.46', 'spread': '6.34', 'groupId': 'OG003'}, {'value': '-5.02', 'spread': '5.06', 'groupId': 'OG004'}, {'value': '-4.11', 'spread': '6.20', 'groupId': 'OG005'}, {'value': '1.15', 'spread': '4.08', 'groupId': 'OG006'}, {'value': '-12.36', 'spread': '4.80', 'groupId': 'OG007'}]}]}, {'title': 'HbA1C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '7.36', 'spread': '4.05', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '2.84', 'groupId': 'OG001'}, {'value': '3.05', 'spread': '2.99', 'groupId': 'OG002'}, {'value': '-3.66', 'spread': '3.42', 'groupId': 'OG003'}, {'value': '-1.85', 'spread': '2.60', 'groupId': 'OG004'}, {'value': '6.89', 'spread': '3.43', 'groupId': 'OG005'}, {'value': '0.61', 'spread': '2.28', 'groupId': 'OG006'}, {'value': '-7.23', 'spread': '1.66', 'groupId': 'OG007'}]}]}, {'title': 'Alanine Transaminase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-16.87', 'spread': '10.62', 'groupId': 'OG000'}, {'value': '-26.65', 'spread': '6.99', 'groupId': 'OG001'}, {'value': '-26.73', 'spread': '7.40', 'groupId': 'OG002'}, {'value': '-43.69', 'spread': '8.55', 'groupId': 'OG003'}, {'value': '-18.83', 'spread': '6.38', 'groupId': 'OG004'}, {'value': '-39.84', 'spread': '8.42', 'groupId': 'OG005'}, {'value': '-4.18', 'spread': '5.47', 'groupId': 'OG006'}, {'value': '-45.80', 'spread': '3.86', 'groupId': 'OG007'}]}]}, {'title': 'Aspartate Aminotransferase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-29.36', 'spread': '9.47', 'groupId': 'OG000'}, {'value': '-19.90', 'spread': '6.15', 'groupId': 'OG001'}, {'value': '-15.10', 'spread': '6.52', 'groupId': 'OG002'}, {'value': '-37.88', 'spread': '7.52', 'groupId': 'OG003'}, {'value': '-11.41', 'spread': '5.63', 'groupId': 'OG004'}, {'value': '-25.32', 'spread': '7.43', 'groupId': 'OG005'}, {'value': '-4.40', 'spread': '4.85', 'groupId': 'OG006'}, {'value': '-47.28', 'spread': '3.54', 'groupId': 'OG007'}]}]}, {'title': 'Pro-C3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-19.71', 'spread': '14.53', 'groupId': 'OG000'}, {'value': '-18.79', 'spread': '9.02', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '9.38', 'groupId': 'OG002'}, {'value': '-27.67', 'spread': '11.20', 'groupId': 'OG003'}, {'value': '-11.18', 'spread': '8.19', 'groupId': 'OG004'}, {'value': '-12.76', 'spread': '11.22', 'groupId': 'OG005'}, {'value': '3.26', 'spread': '7.02', 'groupId': 'OG006'}, {'value': '-19.52', 'spread': '3.28', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Part 1: Baseline, Day 92; Part 2: Baseline, Day 141', 'description': 'LS Mean was calculated using MMRM.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis set included all randomized participants who received at least 1 dose of study intervention and who had measurable post-baseline PD data in Parts 1 and 2. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part 1: Percent Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Day 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG006', 'title': 'Part 1: Placebo QW or Q2W', 'description': 'Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.37', 'spread': '51.30', 'groupId': 'OG000'}, {'value': '7.40', 'spread': '30.62', 'groupId': 'OG001'}, {'value': '37.07', 'spread': '20.87', 'groupId': 'OG002'}, {'value': '-41.42', 'spread': '19.48', 'groupId': 'OG003'}, {'value': '-4.57', 'spread': '15.57', 'groupId': 'OG004'}, {'value': '-41.11', 'spread': '23.39', 'groupId': 'OG005'}, {'value': '-0.09', 'spread': '15.72', 'groupId': 'OG006'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 92', 'description': 'LS Mean was calculated using MMRM. HOMA-IR value was calculated by multiplying fasting Glucose (mg/dL) with fasting Insulin (uIU/ml) and then dividing by 405.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis set included all randomized participants who received at least 1 dose of investigational product and who had measurable post-baseline PD data in Part 1. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part 1: Percent Change From Baseline in Adiponectin at Day 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85'}, {'id': 'OG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85'}, {'id': 'OG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85'}, {'id': 'OG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85'}, {'id': 'OG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85'}, {'id': 'OG006', 'title': 'Part 1: Placebo QW or Q2W', 'description': 'Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.65', 'spread': '14.48', 'groupId': 'OG000'}, {'value': '25.46', 'spread': '9.88', 'groupId': 'OG001'}, {'value': '29.09', 'spread': '10.47', 'groupId': 'OG002'}, {'value': '60.85', 'spread': '12.00', 'groupId': 'OG003'}, {'value': '23.11', 'spread': '9.07', 'groupId': 'OG004'}, {'value': '24.14', 'spread': '12.10', 'groupId': 'OG005'}, {'value': '-4.25', 'spread': '7.80', 'groupId': 'OG006'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 92', 'description': 'LS Mean was calculated using MMRM.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis set included all randomized participants who received at least 1 dose of investigational product and who had measurable post-baseline PD data in Part 1. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part 1: Percent Change From Baseline in Free Fatty Acid at Day 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG006', 'title': 'Part 1: Placebo QW or Q2W', 'description': 'Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.70', 'spread': '24.68', 'groupId': 'OG000'}, {'value': '50.20', 'spread': '21.05', 'groupId': 'OG001'}, {'value': '27.08', 'spread': '17.76', 'groupId': 'OG002'}, {'value': '51.58', 'spread': '22.08', 'groupId': 'OG003'}, {'value': '43.85', 'spread': '18.17', 'groupId': 'OG004'}, {'value': '56.12', 'spread': '20.81', 'groupId': 'OG005'}, {'value': '20.91', 'spread': '13.96', 'groupId': 'OG006'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 92', 'description': 'LS Mean was calculated using MMRM.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis set included all randomized participants who received at least 1 dose of study intervention and who had measurable post-baseline PD data in Part 1. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part 1: Percent Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR) at Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG006', 'title': 'Part 1: Placebo QW or Q2W', 'description': 'Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.12', 'spread': '61.71', 'groupId': 'OG000'}, {'value': '82.00', 'spread': '59.79', 'groupId': 'OG001'}, {'value': '3.28', 'spread': '60.01', 'groupId': 'OG002'}, {'value': '78.40', 'spread': '46.41', 'groupId': 'OG003'}, {'value': '-25.96', 'spread': '42.75', 'groupId': 'OG004'}, {'value': '-10.36', 'spread': '50.33', 'groupId': 'OG005'}, {'value': '-15.82', 'spread': '32.62', 'groupId': 'OG006'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 50', 'description': 'LS Mean was calculated using MMRM. Adipo-IR was derived from fasting insulin and free fatty acid.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis set included all randomized participants who received at least 1 dose of study intervention and who had measurable post-baseline PD data in Part 1. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percent Change From Baseline in Liver Fat as Assessed Via Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG006', 'title': 'Part 1: Placebo QW or Q2W', 'description': 'Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'OG007', 'title': 'Part 2: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.94', 'spread': '11.01', 'groupId': 'OG000'}, {'value': '-49.62', 'spread': '7.73', 'groupId': 'OG001'}, {'value': '-36.11', 'spread': '8.14', 'groupId': 'OG002'}, {'value': '-60.39', 'spread': '9.40', 'groupId': 'OG003'}, {'value': '-43.19', 'spread': '6.99', 'groupId': 'OG004'}, {'value': '-50.39', 'spread': '9.07', 'groupId': 'OG005'}, {'value': '9.77', 'spread': '6.04', 'groupId': 'OG006'}, {'value': '-64.69', 'spread': '3.38', 'groupId': 'OG007'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Part 1: Baseline, Day 92; Part 2: Baseline, Day 141', 'description': 'LS Mean was calculated using MMRM.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis set included all randomized participants who received at least 1 dose of study intervention and who had measurable post-baseline PD data in Parts 1 and 2. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part 2: Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of NASH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 141', 'description': 'Fibrosis improvement was defined as ≥1-stage decrease in NASH CRN fibrosis score.\n\nWorsening of NASH was defined as increase ≥1 point in NAS for ballooning or inflammation.\n\nNASH CRN Fibrosis was staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Histology Biopsy Analysis Set included all enrolled participants who received at least 1 dose of study intervention and who had both baseline (screening or eligible historical) and post-baseline biopsies.'}, {'type': 'SECONDARY', 'title': 'Part 2: Number of Participants With NASH Resolution Without Worsening of Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 141', 'description': 'Resolution of NASH included the total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1).\n\nWorsening of fibrosis was defined as progression of fibrosis ≥1 stage in NASH CRN fibrosis score.\n\nNASH CRN Fibrosis was staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Histology Biopsy Analysis Set included all enrolled participants who received at least 1 dose of study intervention and who had both baseline (screening or eligible historical) and post-baseline biopsies.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: Pegozafermin 3 Milligrams (mg) Weekly (QW)', 'description': 'Participants were administered 3 mg of pegozafermin QW, via subcutaneous (SC) injection, starting on Day 1 through Day 85.'}, {'id': 'FG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'FG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'FG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'FG004', 'title': 'Part 1: Pegozafermin 18 mg Every 2 Weeks (Q2W)', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'FG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'FG006', 'title': 'Part 1: Placebo QW or Q2W', 'description': 'Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'FG007', 'title': 'Part 2: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '19'}, {'groupId': 'FG007', 'numSubjects': '20'}]}, {'type': 'Received 1 Dose of Study Drug', 'comment': 'Randomized Analysis Set. Arm groups were based upon planned treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '19'}, {'groupId': 'FG007', 'numSubjects': '20'}]}, {'type': 'Safety Analysis Set', 'comment': 'Arm groups were based upon the actual treatment received for the purpose of safety analysis.', 'achievements': [{'comment': 'One participant was randomized to the placebo group but received a single dose of pegozafermin 3 mg instead.', 'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'comment': 'One participant was randomized to the placebo group but received a single dose of pegozafermin 3 mg instead.', 'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '101', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: Pegozafermin 3 mg QW', 'description': 'Participants were administered 3 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'BG001', 'title': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'BG002', 'title': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'BG003', 'title': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'BG004', 'title': 'Part 1: Pegozafermin 18 mg Q2W', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'BG005', 'title': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'BG006', 'title': 'Part 1: Placebo QW or Q2W', 'description': 'Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.'}, {'id': 'BG007', 'title': 'Part 2: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.13', 'spread': '8.23', 'groupId': 'BG000'}, {'value': '49.50', 'spread': '11.45', 'groupId': 'BG001'}, {'value': '51.47', 'spread': '13.39', 'groupId': 'BG002'}, {'value': '51.96', 'spread': '9.83', 'groupId': 'BG003'}, {'value': '51.22', 'spread': '8.14', 'groupId': 'BG004'}, {'value': '52.46', 'spread': '8.73', 'groupId': 'BG005'}, {'value': '52.62', 'spread': '8.99', 'groupId': 'BG006'}, {'value': '58.44', 'spread': '9.07', 'groupId': 'BG007'}, {'value': '52.97', 'spread': '1.81', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}, {'value': '65', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '36', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '79', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}, {'value': '22', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '94', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population description: For Part 1, randomized analysis set included all randomized participants who received at least 1 dose of investigational product. For Part 2, Full analysis set included all enrolled participants who received at least 1 dose of investigational product.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-11', 'size': 1074915, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-04T10:00', 'hasProtocol': True}, {'date': '2020-08-21', 'size': 1281091, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-04T10:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Part 1 was blinded, Part 2 was open label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2019-08-04', 'resultsFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2019-08-06', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-04', 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of Participants With Treatment-emergent Adverse Event (TEAEs)', 'timeFrame': 'Up to 113 days', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were defined as AEs occurring at or after the first dose date and time, through study termination, or existing prior to the time of and worsening after the time of the first dose of investigational product. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Part 2: Number of Participants With TEAEs', 'timeFrame': 'Up to 162 days', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were defined as AEs occurring at or after the first dose date and time, through study termination, or existing prior to the time of and worsening after the time of the first dose of investigational product. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Part 1: Maximum Observed Serum Concentration (Cmax) of Pegozafermin', 'timeFrame': 'Predose and up to 168 hours postdose on Day 29'}, {'measure': 'Part 1: Area Under the Serum Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Pegozafermin', 'timeFrame': 'Predose and up to 168 hours postdose on Day 29'}, {'measure': 'Part 1: Time to Peak Serum Concentration (Tmax) of Pegozafermin', 'timeFrame': 'Predose and up to 168 hours postdose on Day 29'}, {'measure': 'Part 1: Terminal Elimination Half-life (t1/2) of Pegozafermin', 'timeFrame': 'Predose and up to 168 hours postdose on Day 29'}, {'measure': 'Part 2: Number of Participants With at Least a 2-point Improvement in NAFLD Activity Score (NAS) With at Least a 1-point Improvement in Ballooning or Lobular Inflammation, and no Worsening of Fibrosis', 'timeFrame': 'Day 141', 'description': 'NAS was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranges from of 0 to 8, with higher scores indicating worse disease severity.\n\nWorsening of fibrosis was defined as progression of fibrosis ≥1 stage in NASH Clinical Research Network (CRN) fibrosis score.\n\nNASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).'}], 'secondaryOutcomes': [{'measure': 'Part 1: Number of Participants With a Positive Anti-Drug Antibodies (ADA) Response to Pegozafermin', 'timeFrame': 'Up to 113 days', 'description': 'Number of participants with anti-pegozafermin antibodies (ADA) with status as ADA positive has been reported.'}, {'measure': 'Parts 1 and 2: Percent Change From Baseline in Body Weight', 'timeFrame': 'Part 1: Baseline, Day 85; Part 2: Baseline, Day 141', 'description': 'Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM).'}, {'measure': 'Parts 1 and 2: Percent Change From Baseline in Triglycerides, High Density Lipoprotein (HDL) Cholesterol (c), Non-HDLc, LDLc, Hemoglobin (HbA1C), Alanine Transaminase, Aspartate Aminotransferase, N-terminal Propeptide of Type III Collagen (Pro-C3)', 'timeFrame': 'Part 1: Baseline, Day 92; Part 2: Baseline, Day 141', 'description': 'LS Mean was calculated using MMRM.'}, {'measure': 'Part 1: Percent Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Day 92', 'timeFrame': 'Baseline, Day 92', 'description': 'LS Mean was calculated using MMRM. HOMA-IR value was calculated by multiplying fasting Glucose (mg/dL) with fasting Insulin (uIU/ml) and then dividing by 405.'}, {'measure': 'Part 1: Percent Change From Baseline in Adiponectin at Day 92', 'timeFrame': 'Baseline, Day 92', 'description': 'LS Mean was calculated using MMRM.'}, {'measure': 'Part 1: Percent Change From Baseline in Free Fatty Acid at Day 92', 'timeFrame': 'Baseline, Day 92', 'description': 'LS Mean was calculated using MMRM.'}, {'measure': 'Part 1: Percent Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR) at Day 50', 'timeFrame': 'Baseline, Day 50', 'description': 'LS Mean was calculated using MMRM. Adipo-IR was derived from fasting insulin and free fatty acid.'}, {'measure': 'Parts 1 and 2: Percent Change From Baseline in Liver Fat as Assessed Via Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)', 'timeFrame': 'Part 1: Baseline, Day 92; Part 2: Baseline, Day 141', 'description': 'LS Mean was calculated using MMRM.'}, {'measure': 'Part 2: Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of NASH', 'timeFrame': 'Day 141', 'description': 'Fibrosis improvement was defined as ≥1-stage decrease in NASH CRN fibrosis score.\n\nWorsening of NASH was defined as increase ≥1 point in NAS for ballooning or inflammation.\n\nNASH CRN Fibrosis was staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).'}, {'measure': 'Part 2: Number of Participants With NASH Resolution Without Worsening of Fibrosis', 'timeFrame': 'Day 141', 'description': 'Resolution of NASH included the total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1).\n\nWorsening of fibrosis was defined as progression of fibrosis ≥1 stage in NASH CRN fibrosis score.\n\nNASH CRN Fibrosis was staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NASH, NAFLD', 'Liver diseases', 'Fatty Liver', 'Metabolic diseases'], 'conditions': ['NASH']}, 'referencesModule': {'references': [{'pmid': '37718721', 'type': 'DERIVED', 'citation': 'Alkhouri N, Lazas D, Loomba R, Frias JP, Feng S, Tseng L, Balic K, Agollah GD, Kwan T, Iyer JS, Morrow L, Mansbach H, Margalit M, Harrison SA. Clinical trial: Effects of pegozafermin on the liver and on metabolic comorbidities in subjects with biopsy-confirmed nonalcoholic steatohepatitis. Aliment Pharmacol Ther. 2023 Nov;58(10):1005-1015. doi: 10.1111/apt.17709. Epub 2023 Sep 18.'}, {'pmid': '37696614', 'type': 'DERIVED', 'citation': 'Tseng CL, Balic K, Charlton RW, Margalit M, Mansbach H, Savic RM. Population Pharmacokinetics and Pharmacodynamics of Pegozafermin in Patients with Nonalcoholic Steatohepatitis. Clin Pharmacol Ther. 2023 Dec;114(6):1323-1331. doi: 10.1002/cpt.3046. Epub 2023 Oct 2.'}, {'pmid': '36521501', 'type': 'DERIVED', 'citation': 'Loomba R, Lawitz EJ, Frias JP, Ortiz-Lasanta G, Johansson L, Franey BB, Morrow L, Rosenstock M, Hartsfield CL, Chen CY, Tseng L, Charlton RW, Mansbach H, Margalit M. Safety, pharmacokinetics, and pharmacodynamics of pegozafermin in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 1b/2a multiple-ascending-dose study. Lancet Gastroenterol Hepatol. 2023 Feb;8(2):120-132. doi: 10.1016/S2468-1253(22)00347-8. Epub 2022 Dec 12.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/S2468-1253(22)00347-8', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Part 1: This is a multi-center evaluation of pegozafermin (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in participants with NASH and NAFLD at high risk of NASH, including a pre-defined number of participants with biopsy confirmed NASH and fibrosis stages F1-F3 to be enrolled.\n\nPart 2: This is a multi-center, open label evaluation of pegozafermin at 27 mg administered weekly for 20 weeks in participants with biopsy-proven NASH (NAS ≥4, fibrosis stage F2 or F3).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Participants must be 21 to 75 years of age inclusive, at the time of signing the informed consent form (ICF).\n* Evidence of steatosis by Fibroscan and magnetic resonance imaging based proton density fat fraction (MRI-PDFF)\n* NASH or NAFLD at high risk for NASH as reflected by AT LEAST ONE of the following:\n* Diagnosis of NASH with fibrosis (stages F1, F2 or F3), without cirrhosis, by percutaneous liver biopsy within 24 months prior to screening\n* Central obesity WITH type 2 diabetes mellitus (T2DM)\n* Central obesity WITH either increased alanine transaminase (ALT) and/or Fibroscan vibration-controlled transient elastography (VCTE) score ≥7 KPa.\n* Part 2 only: Biopsy-proven NASH in a liver biopsy obtained within 24 weeks of baseline with fibrosis stage F2 or F3 and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation. A small number of high risk F1 allowed.\n\nKey Exclusion Criteria:\n\n* Clinically significant disorder or a history of any illness that, in the opinion of the Investigator, might confound the results of the study, or pose additional risk to the participant by participation in the study.\n* History of type 1 diabetes.\n* Weight loss of more than 5% within 3 months prior to Day -1 or more than 10% within 6 months prior to Day -1 or planning to try to lose weight during conduct of study.\n* History of a liver disorder other than NASH or clinical suspicion of a liver disorder other than NASH\n* History of cirrhosis or evidence of cirrhosis'}, 'identificationModule': {'nctId': 'NCT04048135', 'briefTitle': 'A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH', 'organization': {'class': 'INDUSTRY', 'fullName': '89bio, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of BIO89-100 Administered Subcutaneously in Subjects With Nonalcoholic Steatohepatitis (NASH) or With Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH', 'orgStudyIdInfo': {'id': 'BIO89-100-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Pegozafermin 3 milligrams (mg) weekly (QW)', 'description': 'Participants were administered 3 mg of pegozafermin QW, via subcutaneous (SC) injection, starting on Day 1 through Day 85.', 'interventionNames': ['Drug: Pegozafermin']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Pegozafermin 9 mg QW', 'description': 'Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.', 'interventionNames': ['Drug: Pegozafermin']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Pegozafermin 18 mg QW', 'description': 'Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.', 'interventionNames': ['Drug: Pegozafermin']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.', 'interventionNames': ['Drug: Pegozafermin']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Pegozafermin 18 mg Every 2 Weeks (Q2W)', 'description': 'Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.', 'interventionNames': ['Drug: Pegozafermin']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Pegozafermin 36 mg Q2W', 'description': 'Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.', 'interventionNames': ['Drug: Pegozafermin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1: Placebo QW or Q2W', 'description': 'Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Pegozafermin 27 mg QW', 'description': 'Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.', 'interventionNames': ['Drug: Pegozafermin']}], 'interventions': [{'name': 'Pegozafermin', 'type': 'DRUG', 'otherNames': ['BIO89-100'], 'description': 'Subcutaneous injection', 'armGroupLabels': ['Part 1: Pegozafermin 18 mg Every 2 Weeks (Q2W)', 'Part 1: Pegozafermin 18 mg QW', 'Part 1: Pegozafermin 27 mg QW', 'Part 1: Pegozafermin 3 milligrams (mg) weekly (QW)', 'Part 1: Pegozafermin 36 mg Q2W', 'Part 1: Pegozafermin 9 mg QW', 'Part 2: Pegozafermin 27 mg QW']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Subcutaneous injection', 'armGroupLabels': ['Part 1: Placebo QW or Q2W']}]}, 'contactsLocationsModule': {'locations': [{'zip': 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'country': 'United States', 'facility': '89bio Clinical Study Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': '89bio Clinical Study Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76301', 'city': 'Wichita Falls', 'state': 'Texas', 'country': 'United States', 'facility': '89bio Clinical Study Site', 'geoPoint': {'lat': 33.91371, 'lon': -98.49339}}, {'zip': '00927', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': '89bio Clinical Study Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Charlton, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': '89bio, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '89bio, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ProSciento, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}