Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT04073368
Status:
COMPLETED
Last Update Posted:
2021-07-06
First Post:
2019-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720464', 'term': 'leucine, isoleucine, valine, arginine, glutamine, and N-acetylcysteine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@axcellahealth.com', 'phone': '8573202200', 'title': 'Margaret Koziel, MD', 'organization': 'Axcella Health, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through the Follow-up Visit / Week 18 will be considered treatment-emergent AEs', 'eventGroups': [{'id': 'EG000', 'title': 'AXA1957 High Dose', 'description': 'AXA1957 20.3g\n\nAXA1957: Amino acids, food study', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 10, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'AXA1957 Low Dose', 'description': 'AXA1957 13.5g\n\nAXA1957: Amino acids, food study', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 8, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'AXA1125', 'description': 'AXA1125 24g\n\nAXA1125: Amino acids, food study', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 13, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo 24g\n\nPlacebo: Amino acids, food study', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'laryngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Incidence of Study Product Emergent Adverse Events (AEs) and Any Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AXA1957 High Dose', 'description': 'AXA1957 20.3g\n\nAXA1957: Amino acids, food study'}, {'id': 'OG001', 'title': 'AXA1957 Low Dose', 'description': 'AXA1957 13.5g\n\nAXA1957: Amino acids, food study'}, {'id': 'OG002', 'title': 'AXA1125', 'description': 'AXA1125 24g\n\nAXA1125: Amino acids, food study'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo 24g\n\nPlacebo: Amino acids, food study'}], 'classes': [{'title': 'Any Product Related Product-Emergent AEs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to week 16', 'description': 'Subjects received AXA1125 at 24 g twice daily ( BID), AXA1957 at 20.3 g BID or 13.5 g BID with Product related AEs and any SAEs up to 16 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects received AXA1125 at 24 g BID, AXA1957 at 20.3 g BID or 13.5 g BID, or placebo for up to 16 weeks.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Liver Fat as Assessed by MRI- Proton Density Fat Fraction (PDFF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AXA1957 High Dose', 'description': 'AXA1957 20.3g\n\nAXA1957: Amino acids, food study'}, {'id': 'OG001', 'title': 'AXA1957 Low Dose', 'description': 'AXA1957 13.5g\n\nAXA1957: Amino acids, food study'}, {'id': 'OG002', 'title': 'AXA1125', 'description': 'AXA1125 24g\n\nAXA1125: Amino acids, food study'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo 24g\n\nPlacebo: Amino acids, food study'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.12', 'spread': '24.904', 'groupId': 'OG000'}, {'value': '-20.29', 'spread': '23.064', 'groupId': 'OG001'}, {'value': '-22.88', 'spread': '23.040', 'groupId': 'OG002'}, {'value': '-5.74', 'spread': '20.425', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 16', 'description': 'Relative Changes From Baseline in MRI-PDFF at Week 16 in Overall Subjects (Safety Analysis Population)', 'unitOfMeasure': 'percentage of change of MRI_PDFF', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Relative Changes From Baseline in MRI-PDFF at Week 16 in Overall Subjects (Safety Analysis Population)'}, {'type': 'SECONDARY', 'title': 'Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AXA1957 High Dose', 'description': 'AXA1957 20.3g\n\nAXA1957: Amino acids, food study'}, {'id': 'OG001', 'title': 'AXA1957 Low Dose', 'description': 'AXA1957 13.5g\n\nAXA1957: Amino acids, food study'}, {'id': 'OG002', 'title': 'AXA1125', 'description': 'AXA1125 24g\n\nAXA1125: Amino acids, food study'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo 24g\n\nPlacebo: Amino acids, food study'}], 'classes': [{'categories': [{'measurements': [{'value': '8.421', 'spread': '34.5866', 'groupId': 'OG000'}, {'value': '1.445', 'spread': '3.6396', 'groupId': 'OG001'}, {'value': '-4.369', 'spread': '16.8680', 'groupId': 'OG002'}, {'value': '0.720', 'spread': '4.7074', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 16', 'description': 'Absolute Changes From Baseline in HOMA-IR at Week 16 in Overall Subjects (Safety Analysis Population)', 'unitOfMeasure': 'percentage of change of HOM-IR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Absolute Changes From Baseline in HOMA-IR at Week 16 in Overall Subjects (Safety Analysis Population)'}, {'type': 'SECONDARY', 'title': 'Change in Glucose Homeostasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AXA1957 High Dose', 'description': 'AXA1957 20.3g\n\nAXA1957: Amino acids, food study'}, {'id': 'OG001', 'title': 'AXA1957 Low Dose', 'description': 'AXA1957 13.5g\n\nAXA1957: Amino acids, food study'}, {'id': 'OG002', 'title': 'AXA1125', 'description': 'AXA1125 24g\n\nAXA1125: Amino acids, food study'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo 24g\n\nPlacebo: Amino acids, food study'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0138', 'spread': '0.01419', 'groupId': 'OG000'}, {'value': '.0001', 'spread': '0.00588', 'groupId': 'OG001'}, {'value': '-0.0070', 'spread': '8.008', 'groupId': 'OG002'}, {'value': '-0.0027', 'spread': '0.00874', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 16', 'description': 'Absolute Changes From Baseline in HbA1c at Week 16 in Subjects with Diabetes (Safety Analysis Population)', 'unitOfMeasure': 'change in HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Absolute Changes From Baseline in HbA1c at Week 16 in Subjects with Diabetes (Safety Analysis Population)'}, {'type': 'SECONDARY', 'title': 'Relative Change in Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AXA1957 High Dose', 'description': 'AXA1957 20.3g\n\nAXA1957: Amino acids, food study'}, {'id': 'OG001', 'title': 'AXA1957 Low Dose', 'description': 'AXA1957 13.5g\n\nAXA1957: Amino acids, food study'}, {'id': 'OG002', 'title': 'AXA1125', 'description': 'AXA1125 24g\n\nAXA1125: Amino acids, food study'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo 24g\n\nPlacebo: Amino acids, food study'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.65', 'spread': '30.163', 'groupId': 'OG000'}, {'value': '-19.19', 'spread': '30.559', 'groupId': 'OG001'}, {'value': '-21.86', 'spread': '25.991', 'groupId': 'OG002'}, {'value': '-7.20', 'spread': '36.483', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 16', 'description': 'Relative Changes From Baseline in ALT at Week 16 in Overall Subjects (Safety Analysis Population)', 'unitOfMeasure': 'percentage change of ALT', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Relative Changes From Baseline in ALT at Week 16 in Overall Subjects (Safety Analysis Population)'}, {'type': 'SECONDARY', 'title': 'Change in Aspartate Aminotransferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AXA1957 High Dose', 'description': 'AXA1957 20.3g\n\nAXA1957: Amino acids, food study'}, {'id': 'OG001', 'title': 'AXA1957 Low Dose', 'description': 'AXA1957 13.5g\n\nAXA1957: Amino acids, food study'}, {'id': 'OG002', 'title': 'AXA1125', 'description': 'AXA1125 24g\n\nAXA1125: Amino acids, food study'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo 24g\n\nPlacebo: Amino acids, food study'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.40', 'spread': '30.898', 'groupId': 'OG000'}, {'value': '-17.02', 'spread': '30.898', 'groupId': 'OG001'}, {'value': '-16.76', 'spread': '27.908', 'groupId': 'OG002'}, {'value': '-7.49', 'spread': '40.499', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'Relative Changes From Baseline in AST at Week 16 in Overall Subjects (Safety Analysis Population)', 'unitOfMeasure': 'percentage of AST from basline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Relative Changes From Baseline in AST at Week 16 in Overall Subjects (Safety Analysis Population)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AXA1957 High Dose', 'description': 'AXA1957 20.3g\n\nAXA1957: Amino acids, food study'}, {'id': 'FG001', 'title': 'AXA1957 Low Dose', 'description': 'AXA1957 13.5g\n\nAXA1957: Amino acids, food study'}, {'id': 'FG002', 'title': 'AXA1125', 'description': 'AXA1125 24g\n\nAXA1125: Amino acids, food study'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo 24g\n\nPlacebo: Amino acids, food study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '112 subjects signed consent and randomized. Ten subjects screen failed prior to day 1 dosing ( after signing consent) and the number of participants who started the study is 102 subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'AXA1957 High Dose', 'description': 'AXA1957 20.3g\n\nAXA1957: Amino acids, food study'}, {'id': 'BG001', 'title': 'AXA1957 Low Dose', 'description': 'AXA1957 13.5g\n\nAXA1957: Amino acids, food study'}, {'id': 'BG002', 'title': 'AXA1125', 'description': 'AXA1125 24g\n\nAXA1125: Amino acids, food study'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo 24g\n\nPlacebo: Amino acids, food study'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.1', 'spread': '12.79', 'groupId': 'BG000'}, {'value': '49.6', 'spread': '10.74', 'groupId': 'BG001'}, {'value': '49.2', 'spread': '12.79', 'groupId': 'BG002'}, {'value': '53.2', 'spread': '9.62', 'groupId': 'BG003'}, {'value': '50.2', 'spread': '11.77', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}, {'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'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type 2 diabetes mellitus status (T2DM)', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This is the safety analysis population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-01', 'size': 879086, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-14T11:20', 'hasProtocol': True}, {'date': '2020-03-09', 'size': 494291, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-14T11:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-01', 'studyFirstSubmitDate': '2019-08-27', 'resultsFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2019-08-27', 'lastUpdatePostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-30', 'studyFirstPostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Incidence of Study Product Emergent Adverse Events (AEs) and Any Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline to week 16', 'description': 'Subjects received AXA1125 at 24 g twice daily ( BID), AXA1957 at 20.3 g BID or 13.5 g BID with Product related AEs and any SAEs up to 16 weeks'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Liver Fat as Assessed by MRI- Proton Density Fat Fraction (PDFF)', 'timeFrame': 'Baseline to week 16', 'description': 'Relative Changes From Baseline in MRI-PDFF at Week 16 in Overall Subjects (Safety Analysis Population)'}, {'measure': 'Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)', 'timeFrame': 'Baseline to week 16', 'description': 'Absolute Changes From Baseline in HOMA-IR at Week 16 in Overall Subjects (Safety Analysis Population)'}, {'measure': 'Change in Glucose Homeostasis', 'timeFrame': 'Baseline to week 16', 'description': 'Absolute Changes From Baseline in HbA1c at Week 16 in Subjects with Diabetes (Safety Analysis Population)'}, {'measure': 'Relative Change in Alanine Aminotransferase (ALT)', 'timeFrame': 'Baseline to week 16', 'description': 'Relative Changes From Baseline in ALT at Week 16 in Overall Subjects (Safety Analysis Population)'}, {'measure': 'Change in Aspartate Aminotransferase (AST)', 'timeFrame': 'Baseline to Week 16', 'description': 'Relative Changes From Baseline in AST at Week 16 in Overall Subjects (Safety Analysis Population)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NAFLD']}, 'referencesModule': {'references': [{'pmid': '34382947', 'type': 'DERIVED', 'citation': 'Harrison SA, Baum SJ, Gunn NT, Younes ZH, Kohli A, Patil R, Koziel MJ, Chera H, Zhao J, Chakravarthy MV. Safety, Tolerability, and Biologic Activity of AXA1125 and AXA1957 in Subjects With Nonalcoholic Fatty Liver Disease. Am J Gastroenterol. 2021 Dec 1;116(12):2399-2409. doi: 10.14309/ajg.0000000000001375.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, single blind study to determine whether AXA1125 or AXA1957, novel compositions of amino acids, are safe and well tolerated. Subjects have non-alcoholic fatty liver disease (NAFLD) and the study will also examine liver biology using blood tests and magnetic resonance imaging (MRI).', 'detailedDescription': 'This was a 16-week, single-blind, randomized, placebo-controlled food study of the safety and tolerability of AXA1125 and AXA1957 in subjects with NAFLD.\n\nSubjects signed an informed consent form and were screened for eligibility, per the inclusion and exclusion criteria below, up to 6 weeks before the start of the administration period. Subjects were randomized as soon as eligibility was confirmed.\n\nEligible subjects were randomized in a 2:2:2:1 ratio to receive either AXA1125 24 g twice daily (BID), AXA1957 20.3 g BID, AXA1957 13.5 g BID, or placebo 24 g BID. Randomization occurred via an interactive web response system after eligibility was confirmed and approximately 3 to 5 days prior to the Day 1 visit. Assigned study food product (AXA1125, AXA1957, or placebo) were shipped to the study site upon randomization of each subject.\n\nOnce randomization had occurred, subjects presented to the study site on Day 1 (Baseline/Visit 2) for their baseline assessments per the schedule of events. Study Day 1 was the beginning of the 16-week administration period.\n\nSubjects returned to the study site at Week 1 (Visit 3), Week 2 (Visit 4), Week 4 (Visit 5), Week 8 (Visit 6), Week 12 (Visit 7), and Week 16 (Visit 8) to receive their study food product and/or to return any unused study food product, provide blood samples for biomarker and other laboratory testing, undergo liver imaging, and complete other study safety assessments per the schedule of events.\n\nThe Safety Follow-up Visit, which occurred approximately 2 weeks after the last visit in the administration period (ie, after the Week 16 visit or at the time of early termination), was the End of Study Visit (Visit 9).\n\nThere were 9 study visits in total, including the Screening and Follow-up Visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Willing to participate in the study and provide written informed consent.\n* Male and female adults aged \\> 18 years.\n* Subjects must not have participated in any diet/lifestyle intervention or observational studies, or engaged in any body weight altering regimens that resulted in body weight fluctuations (i.e. body weight loss or gain by 5%) in the preceding 3 months prior to Screening.\n* A screening MRI consistent with liver inflammation and fibrosis.\n\nKey Exclusion Criteria:\n\n* Current or history of significant alcohol consumption.\n* History or presence of liver disease (other than NAFLD/NASH).\n* History or presence of cirrhosis and/or history or presence of hepatic decompensation.\n* Any diabetes other than Type 2.\n* Other poorly controlled medical condition (for example, uncontrolled hypertension with a systolic blood pressure \\> 100 mmHg).\n* Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.).\n* Unable or unwilling to adhere to contraception requirements.\n* Any contraindications to a MRI scan.\n* Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion.'}, 'identificationModule': {'nctId': 'NCT04073368', 'briefTitle': 'Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Axcella Health, Inc'}, 'officialTitle': 'A 16-Week, Single-Blind Randomized, Placebo- Controlled Food Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)', 'orgStudyIdInfo': {'id': 'AXA1125-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AXA1957 high dose', 'description': 'AXA1957 20.3g', 'interventionNames': ['Dietary Supplement: AXA1957']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AXA1957 low dose', 'description': 'AXA1957 13.5g', 'interventionNames': ['Dietary Supplement: AXA1957']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AXA1125', 'description': 'AXA1125 24g', 'interventionNames': ['Dietary Supplement: AXA1125']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo 24g', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'AXA1957', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Amino acids, food study', 'armGroupLabels': ['AXA1957 high dose', 'AXA1957 low dose']}, {'name': 'AXA1125', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Amino acids, food study', 'armGroupLabels': ['AXA1125']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Amino acids, food study', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'The Institute for Liver Health LLC', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85641', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'The Institute for Liver Health LLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '90010', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute - Wilshire', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91762', 'city': 'Montclair', 'state': 'California', 'country': 'United States', 'facility': 'Catalina Research Institute, LLC', 'geoPoint': {'lat': 34.07751, 'lon': -117.68978}}, {'zip': '91402', 'city': 'Panorama City', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute - Panorama', 'geoPoint': {'lat': 34.22473, 'lon': -118.44981}}, {'zip': '33427', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Excel Medical Clinical Trials, LLC', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '34202', 'city': 'Lakewood Rch', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Digestive Health Specialists', 'geoPoint': {'lat': 27.3863, 'lon': -82.4332}}, {'zip': '32789', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research, LLC - Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Bioclinica Research', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '39056', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Southern Therapy and Advanced Research LLC', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '64030', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City Research Institute', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '20874', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Gastro One', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '73301', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Pinnacle Clinical Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75234', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Liver Center of Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78504', 'city': 'Edinburg', 'state': 'Texas', 'country': 'United States', 'facility': 'Doctors Hospital at Renaissance, LLC', 'geoPoint': {'lat': 26.30174, 'lon': -98.16334}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Digestive Disease Consultants (TDDC) - Downtown Fort Worth', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78201', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Pinnacle Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Stephen Harrison, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pinnacle Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Axcella Health, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}