Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT04447820
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2020-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CTGResults@KowaUS.com', 'phone': '919-433-1600', 'title': 'Director, Clinical Operations', 'organization': 'Kowa Research Institute, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '28 Days', 'description': '1. The Safety Analysis Set was defined as all randomized participants who received at least 1 dose of the randomized study drug.\n2. Treatment-emergent AEs (TEAEs) were defined as AEs that occurred for the first time after the first dose of study drug or existed prior to the first dose and worsened during the Treatment Period.', 'eventGroups': [{'id': 'EG000', 'title': 'K-877-IR', 'description': 'K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'K-877-ER Dose A', 'description': 'K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 1, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'K-877-ER Dose B', 'description': 'K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 5, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Estimated Percentage Change in Fasting Triglyceride(s) (TG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877-IR', 'description': 'K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28.'}, {'id': 'OG001', 'title': 'K-877-ER Dose A', 'description': 'K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28.'}, {'id': 'OG002', 'title': 'K-877-ER Dose B', 'description': 'K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '-41.57', 'spread': '3.295', 'groupId': 'OG000'}, {'value': '-36.79', 'spread': '3.319', 'groupId': 'OG001'}, {'value': '-38.94', 'spread': '3.553', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3084', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Model for repeated measures (MMRM)', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.'}, {'pValue': '0.5930', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Mixed Model for repeated measures (MMRM)', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Day 28', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-Protocol Set (PPS) was defined as all patients in the Full Analysis Set without any major protocol deviations and who had baseline and Day 28 fasting serum TG measurements.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline to Day 28 in Total Cholesterol (TC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877-IR', 'description': 'K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28.'}, {'id': 'OG001', 'title': 'K-877-ER Dose A', 'description': 'K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28.'}, {'id': 'OG002', 'title': 'K-877-ER Dose B', 'description': 'K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.07', 'spread': '15.417', 'groupId': 'OG000'}, {'value': '-8.68', 'spread': '13.266', 'groupId': 'OG001'}, {'value': '0.28', 'spread': '18.100', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9788', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.'}, {'pValue': '0.1314', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline to Day 28 in Low-density Lipoprotein Cholesterol (LDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877-IR', 'description': 'K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28.'}, {'id': 'OG001', 'title': 'K-877-ER Dose A', 'description': 'K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28.'}, {'id': 'OG002', 'title': 'K-877-ER Dose B', 'description': 'K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.56', 'spread': '28.586', 'groupId': 'OG000'}, {'value': '-2.16', 'spread': '21.394', 'groupId': 'OG001'}, {'value': '22.71', 'spread': '64.420', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.8840', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'MMRM analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.'}, {'pValue': '0.1202', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'MMRM analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline to Day 28 in High-density Lipoprotein Cholesterol (HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877-IR', 'description': 'K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28.'}, {'id': 'OG001', 'title': 'K-877-ER Dose A', 'description': 'K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28.'}, {'id': 'OG002', 'title': 'K-877-ER Dose B', 'description': 'K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.22', 'spread': '27.335', 'groupId': 'OG000'}, {'value': '15.39', 'spread': '18.190', 'groupId': 'OG001'}, {'value': '20.04', 'spread': '24.370', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9353', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.'}, {'pValue': '0.3099', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline to Day 28 in Remnant Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877-IR', 'description': 'K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28.'}, {'id': 'OG001', 'title': 'K-877-ER Dose A', 'description': 'K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28.'}, {'id': 'OG002', 'title': 'K-877-ER Dose B', 'description': 'K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.85', 'spread': '32.467', 'groupId': 'OG000'}, {'value': '-30.08', 'spread': '25.394', 'groupId': 'OG001'}, {'value': '-32.34', 'spread': '24.761', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2098', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.'}, {'pValue': '0.3688', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'unitOfMeasure': 'Percentage Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline to Day 28 in Non-HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877-IR', 'description': 'K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28.'}, {'id': 'OG001', 'title': 'K-877-ER Dose A', 'description': 'K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28.'}, {'id': 'OG002', 'title': 'K-877-ER Dose B', 'description': 'K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.04', 'spread': '21.704', 'groupId': 'OG000'}, {'value': '-11.12', 'spread': '18.847', 'groupId': 'OG001'}, {'value': '-3.74', 'spread': '21.394', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5647', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.'}, {'pValue': '0.2170', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline to Day 28 in Free Fatty Acid (FFAs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877-IR', 'description': 'K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28.'}, {'id': 'OG001', 'title': 'K-877-ER Dose A', 'description': 'K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28.'}, {'id': 'OG002', 'title': 'K-877-ER Dose B', 'description': 'K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.35', 'spread': '45.110', 'groupId': 'OG000'}, {'value': '-17.17', 'spread': '25.430', 'groupId': 'OG001'}, {'value': '-10.22', 'spread': '40.436', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2562', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.'}, {'pValue': '0.4268', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 28', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'K-877 PK Parameters Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877-IR', 'description': 'K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28.'}, {'id': 'OG001', 'title': 'K-877-ER Dose A', 'description': 'K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28.'}, {'id': 'OG002', 'title': 'K-877-ER Dose B', 'description': 'K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.061', 'spread': '63.9', 'groupId': 'OG000'}, {'value': '2.746', 'spread': '85.2', 'groupId': 'OG001'}, {'value': '5.433', 'spread': '61.2', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28', 'description': 'Observed maximum measured plasma concentration (Cmax)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set included all patients from the Safety Analysis Set who had at least 1 PK sample.'}, {'type': 'SECONDARY', 'title': 'K-877 PK Parameters AUC (Tau)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'K-877-IR', 'description': 'K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28.'}, {'id': 'OG001', 'title': 'K-877-ER Dose A', 'description': 'K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28.'}, {'id': 'OG002', 'title': 'K-877-ER Dose B', 'description': 'K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.239', 'spread': '43.1', 'groupId': 'OG000'}, {'value': '22.566', 'spread': '71.3', 'groupId': 'OG001'}, {'value': '41.611', 'spread': '44.1', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28', 'unitOfMeasure': 'h-ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set included all patients from the Safety Analysis Set who had at least 1 PK sample.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'K-877-IR', 'description': 'K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28.'}, {'id': 'FG001', 'title': 'K-877-ER Dose A', 'description': 'K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28.'}, {'id': 'FG002', 'title': 'K-877-ER Dose B', 'description': 'K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'The Screening Period occurred no more than 70 days and no less than 7 days prior to the first dose of study drug. The up to 10-week Screening Period allowed for a 6-week washout period, if needed, followed by an up to 4-week Qualification Period that was used to assess patient eligibility. Prior to treatment on Day 1, eligible patients were randomized in a 1:1:1 ratio to 1 of 3 treatment groups. Randomization was stratified by sex, statin use, and PK assessment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'K-877-IR', 'description': 'K-877 Immediate release (IR) tablet orally twice daily (BID) from day 1 through 28.'}, {'id': 'BG001', 'title': 'K-877-ER Dose A', 'description': 'K-877 Extended release (ER) tablet (Dose A) orally once daily (QD) from day 1 through 28.'}, {'id': 'BG002', 'title': 'K-877-ER Dose B', 'description': 'K-877 Extended release (ER) tablets (Dose B) orally once daily (QD) from day 1 through 28.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Statin Use', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'TG at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '278.72', 'spread': '53.316', 'groupId': 'BG000'}, {'value': '294.88', 'spread': '61.949', 'groupId': 'BG001'}, {'value': '307.35', 'spread': '73.575', 'groupId': 'BG002'}, {'value': '293.65', 'spread': '63.915', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Full Analysis Set (FAS) was defined as all randomized patients who took at least 1 dose of study drug and had a baseline fasting TG assessment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-28', 'size': 5235690, 'label': 'Study Protocol: Ver: 1.0', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-30T11:53', 'hasProtocol': True}, {'date': '2020-09-17', 'size': 5522310, 'label': 'Study Protocol: Ver: 2.0', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-30T11:55', 'hasProtocol': True}, {'date': '2020-08-21', 'size': 1250639, 'label': 'Statistical Analysis Plan: Ver 1.0', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-30T11:56', 'hasProtocol': False}, {'date': '2020-11-23', 'size': 750545, 'label': 'Statistical Analysis Plan: Ver 2.0', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-30T11:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-11', 'dispFirstSubmitDate': '2021-12-01', 'completionDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2020-06-19', 'dispFirstSubmitQcDate': '2021-12-01', 'resultsFirstSubmitDate': '2023-11-30', 'studyFirstSubmitQcDate': '2020-06-24', 'dispFirstPostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-30', 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated Percentage Change in Fasting Triglyceride(s) (TG)', 'timeFrame': 'Baseline to Day 28'}], 'secondaryOutcomes': [{'measure': 'Percentage Change From Baseline to Day 28 in Total Cholesterol (TC)', 'timeFrame': 'Baseline to Day 28'}, {'measure': 'Percentage Change From Baseline to Day 28 in Low-density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'Baseline to Day 28'}, {'measure': 'Percentage Change From Baseline to Day 28 in High-density Lipoprotein Cholesterol (HDL-C)', 'timeFrame': 'Baseline to Day 28'}, {'measure': 'Percentage Change From Baseline to Day 28 in Remnant Cholesterol', 'timeFrame': 'Baseline to Day 28'}, {'measure': 'Percentage Change From Baseline to Day 28 in Non-HDL-C', 'timeFrame': 'Baseline to Day 28'}, {'measure': 'Percentage Change From Baseline to Day 28 in Free Fatty Acid (FFAs)', 'timeFrame': 'Baseline to Day 28'}, {'measure': 'K-877 PK Parameters Cmax', 'timeFrame': 'Day 28', 'description': 'Observed maximum measured plasma concentration (Cmax)'}, {'measure': 'K-877 PK Parameters AUC (Tau)', 'timeFrame': 'Day 28'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'A study to evaluate the efficacy of K-877 extended release (ER) once daily (QD) compared to K-877 immediate release (IR) twice daily (BID).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide written informed consent before any study-specific evaluation is performed\n* At screening, have a mean fasting TG level of ≥180 mg/dL and \\<550 mg/dL; at subsequent Qualification Period visits confirm fasting TG level of ≥200 mg/dL and \\<500 mg/dL\n* Able to meet all inclusion criteria outlined in clinical study protocol\n\nExclusion Criteria:\n\n* Require lipid-altering treatments other than study drugs, statins, ezetimibe, or PCSK9 inhibitors during the study\n* Known hypersensitivity or intolerance to fibrates or peroxisome proliferator-activated receptor alpha agonists\n* Meet any other exclusion criteria outlined in clinical study protocol'}, 'identificationModule': {'nctId': 'NCT04447820', 'briefTitle': 'Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kowa Research Institute, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Open-Label, 4-Week Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Once Daily Treatment Compared to K-877-IR Twice Daily Treatment in Adult Patients With Fasting Triglyceride Levels', 'orgStudyIdInfo': {'id': 'K-877-ER-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'K-877-ER Dose A', 'description': 'K-877-ER dose A administered once daily', 'interventionNames': ['Drug: K-877-ER (Dose A)']}, {'type': 'EXPERIMENTAL', 'label': 'K-877-ER Dose B', 'description': 'K-877-ER dose B administered once daily', 'interventionNames': ['Drug: K-877-ER (Dose B)']}, {'type': 'EXPERIMENTAL', 'label': 'K-877-IR', 'description': 'K-877-IR administered twice daily.', 'interventionNames': ['Drug: K-877-IR']}], 'interventions': [{'name': 'K-877-ER (Dose A)', 'type': 'DRUG', 'description': 'Dose A Oral Administration', 'armGroupLabels': ['K-877-ER Dose A']}, {'name': 'K-877-ER (Dose B)', 'type': 'DRUG', 'description': 'Dose B Oral Administration', 'armGroupLabels': ['K-877-ER Dose B']}, {'name': 'K-877-IR', 'type': 'DRUG', 'description': 'K-877-IR Oral Administration', 'armGroupLabels': ['K-877-IR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Progressive Medical Research', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Columbus Regional Health', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Prism Research', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Diabetes and Endocrinology Consultants, P.C.', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Medpace Clinical Pharmacology, LLC', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Aventiv Research, Inc.', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '44262', 'city': 'Munroe Falls', 'state': 'Ohio', 'country': 'United States', 'facility': 'Summit Research Group, LLC', 'geoPoint': {'lat': 41.1445, 'lon': -81.43983}}, {'zip': '57702', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Health Concepts', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '20110', 'city': 'Manassas', 'state': 'Virginia', 'country': 'United States', 'facility': 'Manassas Clinical Research Center', 'geoPoint': {'lat': 38.75095, 'lon': -77.47527}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kowa Research Institute, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}