Trial · NCT04321031
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Proportion of Participants Achieving Resolution of NASH Without Worsening/Improvement of Fibrosis by >=1 Stage Without Worsening of NASH/Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48:Bayesian Dose Response Model (BDRM) | Week 48 | BKS: scaling for fibrosis (0=none,1=perisinusoidal/ periportal,2=perisinusoidal, portal/ periportal,3=bridging,4=cirrhosis; higher scores=more DA). Full analysis set (FAS):all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID). | Proportion of participants | MEAN |
| PRIMARY | Number of Participants Achieving Resolution of NASH Without Worsening or Improvement in Fibrosis by >= 1 Stage Without Worsening of NASH or Both Based on Assessment by Sponsor-Identified Central Pathologist at Week 48: Logistic Regression Model | Week 48 | BKS: scaling for fibrosis (0= none, 1= perisinusoidal/ periportal, 2= perisinusoidal, portal/periportal, 3= bridging, 4= cirrhosis; higher scores= more disease activity). Logistic Regression model included treatment and baseline F2/F3 as factors. Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for the primary endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Liver Fat at Week 48: Bayesian Dose Response Model | Baseline, Week 48 | Full analysis set: all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID). Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Liver Fat at Week 48: Pairwise Comparisons With Analysis of Covariance (ANCOVA) | Baseline, Week 48 | Full analysis set: all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Proportion of Participants Achieving Resolution of NASH, Without Worsening of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model | Week 48 | FAS included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID). | Proportion of participants | MEAN |
| SECONDARY | Number of Participants Achieving Resolution of NASH, Without Worsening of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model | Week 48 | Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Proportion of Participants Achieving Improvement in Fibrosis by >=1 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model | Week 48 | Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID). | Proportion of participants | MEAN |
| SECONDARY | Number of Participants Achieving Improvement in Fibrosis by >=1 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model | Week 48 | Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Proportion of Participants Achieving Improvement in Fibrosis by >=2 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model | Week 48 | Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID). | Proportion of participants | MEAN |
| SECONDARY | Number of Participants Achieving Improvement in Fibrosis by >=2 Stage, Without Worsening of NASH Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model | Week 48 | Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Proportion of Participants Achieving Improvement of >=2 Points in Total NAS, Without Progression of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Bayesian Dose Response Model | Week 48 | Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. This outcome measure was not planned to be analyzed in combination arms (DGAT2i/PF-06865571 150 mg BID + ACCi/PF-05221304 5 mg BID and DGAT2i/PF-06865571 300 mg BID + ACCi/PF-05221304 10 mg BID). | Proportion of participants | MEAN |
| SECONDARY | Number of Participants Achieving Improvement of >=2 Points in Total NAS Without Progression of Fibrosis Based on Assessment by Sponsor-Identified Central Pathologist(s) at Week 48: Pairwise Comparisons With Logistic Regression Model | Week 48 | Full analysis set included all randomized participants who took at least 1 dose of investigational product who had provided baseline data for primary endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks) | Safety population included all participants who took at least 1 dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities | From first dose of study drug (Day 1) up to 4 weeks after last dose of study drug (maximum up to approximately 52 weeks) | Safety population included all participants who took at least 1 dose of investigational product. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Vital Signs | From first dose of study drug (Day 1) upto Week 48 (maximum up to approximately 50 weeks) | Safety population included all participants who took at least 1 dose of investigational product. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECG) Parameters | From first dose of study drug (Day 1) upto Week 48 (maximum up to approximately 50 weeks) | Safety population included all participants who took at least 1 dose of investigational product. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04321031/outcomes