Trial · NCT03776175
A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.
NCT03776175, Phase 2, Completed, Pfizer; results first posted 2020-09-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease. Trials, record NCT03776175. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03776175
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.
- NCT number
- NCT03776175
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 99 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Non-Alcoholic Fatty Liver Disease (NAFLD)
- Interventions
- PF-05221304 Monotherapy, PF-06865571 Monotherapy, Placebo, PF-05221304 and PF-06865571 Combination
- First posted
- 2018-12-14
- Last updated
- 2020-09-23
- Results first posted
- 2020-09-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42 | Baseline, Day 42 | Magnetic resonance imaging proton density fat fraction (MRI-PDFF) technique is an established method that enables quantification of fat content in the liver. It measures the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF = PDFFs for (Segment I + Segment II + Segment III + Segment IVa + Segment IVb + Segment V + Segment VI + Segment VII + Segment VIII) divided by total number of segments assessed. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 35 days from last dose of study drug or early termination: (maximum up to Day 77) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included all serious and non-serious adverse events. |
| Secondary | Number of Participants With Laboratory Abnormalities | Baseline up to 35 days last from dose of study drug or early termination (maximum up to Day 77) | Clinical chemistry: Bilirubin (milligram per deciliter \[mg/dL\]), direct bilirubin (mg/dL)\>3.0\*upper limit of normal (ULN), alanine aminotransferase international units per liter (U/L), aspartate aminotransferase (U/L), alkaline phosphatase (U/L), gamma glutamyl transferase (U/L)\>5.0\*ULN, urea nitrogen (mg/dL)\>2.0\*ULN, low density lipoprotein direct endpoint measure (mg/dL)\>1.5\*ULN, triglycerides (mg/dL)\>2.0\*ULN, creatinine based estimated glomerular filtration rate by modification of diet in renal disease equation and cystatin based eGFR by chronic kidney disease epidemiology collaboration equation (C \<60 milliliter per minute per 1.73 square of meter), very low density lipoprotein (millimoles per liter), Cholesterol \>2.0\*ULN. |
| Secondary | Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Blood Pressure | Baseline, Post-last dose of study drug (up to Day 42) | Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate. |
| Secondary | Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Pulse Rate | Baseline, Post- last dose of study drug (up to Day 42) | Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate. |
| Secondary | Number of Participants Meeting Pre-Specified Electrocardiogram (ECG) Criteria | Baseline up to 35 days last dose of study drug or early termination (maximum up to Day 77) | ECG criteria included: 1) PR interval (milliseconds \[msec\]): baseline greater than (\>) 200 msec and maximum increase from baseline greater than or equal to (\>=) 25 percent (%) or baseline less than or equal to (\<=) 200 msec and maximum increase from baseline \>=50%; 2) QRS interval (msec): maximum increase from baseline \>=50%; 3) QT interval corrected using Fridericia's formula (QTcF): a) change from baseline \>30 msec and \<=60 msec, b) change from baseline \>60 msec. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42 | Baseline, Day 42 | Full analysis set population included all randomized participants who received at least 1 dose of investigational product and participants were assigned to the randomized treatment regardless of what treatment was received. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 35 days from last dose of study drug or early termination: (maximum up to Day 77) | Safety analysis population included all participants who received at least 1 dose of investigational product post-randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Abnormalities | Baseline up to 35 days last from dose of study drug or early termination (maximum up to Day 77) | Safety analysis population included all participants who received at least 1 dose of investigational product. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for laboratory abnormalities. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Blood Pressure | Baseline, Post-last dose of study drug (up to Day 42) | Safety analysis population included all participants who received at least 1 dose of investigational product post-randomization. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | millimeter of mercury | MEAN |
| SECONDARY | Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Pulse Rate | Baseline, Post- last dose of study drug (up to Day 42) | Safety analysis population included all participants who received at least 1 dose of investigational product post-randomization. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | beats per minute | MEAN |
| SECONDARY | Number of Participants Meeting Pre-Specified Electrocardiogram (ECG) Criteria | Baseline up to 35 days last dose of study drug or early termination (maximum up to Day 77) | Safety analysis population included all participants who received at least 1 dose of investigational product post-randomization. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42 | Placebo | 8.14 | 90% Confidence Interval -8.56 to 27.89 | percent change | |
| Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42 | PF-05221304 15mg + Placebo | -40.01 | 90% Confidence Interval -47.00 to -32.09 | percent change | |
| Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42 | PF-06865571 300 mg + Placebo | -30.14 | 90% Confidence Interval -37.97 to -21.33 | percent change | |
| Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42 | PF-05221304 15 mg + PF-06865571 300 mg | -40.13 | 90% Confidence Interval -46.58 to -32.90 | percent change | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | Participants With AEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | PF-05221304 15mg + Placebo | Participants With AEs | 10 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | PF-06865571 300 mg + Placebo | Participants With AEs | 10 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | PF-05221304 15 mg + PF-06865571 300 mg | Participants With AEs | 10 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | Participants With SAEs | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | PF-05221304 15mg + Placebo | Participants With SAEs | 0 | Participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (42 Days) | STARTED | Placebo | 14 | |
| Treatment Period (42 Days) | STARTED | PF-05221304 15mg + Placebo | 29 | |
| Treatment Period (42 Days) | STARTED | PF-06865571 300 mg + Placebo | 28 | |
| Treatment Period (42 Days) | STARTED | PF-05221304 15 mg + PF-06865571 300 mg | 28 | |
| Treatment Period (42 Days) | Treated | Placebo | 14 | |
| Treatment Period (42 Days) | Treated | PF-05221304 15mg + Placebo | 29 | |
| Treatment Period (42 Days) | Treated | PF-06865571 300 mg + Placebo | 28 | |
| Treatment Period (42 Days) | Treated | PF-05221304 15 mg + PF-06865571 300 mg | 28 | |
| Treatment Period (42 Days) | COMPLETED | Placebo | 13 | |
| Treatment Period (42 Days) | COMPLETED | PF-05221304 15mg + Placebo | 22 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 14 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-05221304 15mg + Placebo | 0 | 29 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-06865571 300 mg + Placebo | 1 | 28 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-05221304 |15mg Q12H + |PF-06865571 |300mg Q12H | 0 | 28 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 14 | |
| other | Constipation | Gastrointestinal disorders | PF-05221304 15mg + Placebo | 1 | 29 | |
| other | Constipation | Gastrointestinal disorders | PF-06865571 300 mg + Placebo | 1 | 28 | |
| other | Constipation | Gastrointestinal disorders | PF-05221304 |15mg Q12H + |PF-06865571 |300mg Q12H | 0 | 28 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 14 | |
| other | Diarrhoea | Gastrointestinal disorders | PF-05221304 15mg + Placebo | 1 | 29 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 14 |
| Total, all-cause mortality | PF-05221304 15mg + Placebo | 0 | 29 |
| Total, all-cause mortality | PF-06865571 300 mg + Placebo | 0 | 28 |
| Total, all-cause mortality | PF-05221304 |15mg Q12H + |PF-06865571 |300mg Q12H | 0 | 28 |
| Total, other adverse events | Placebo | 3 | 14 |
| Total, other adverse events | PF-05221304 15mg + Placebo | 6 | 29 |
| Total, other adverse events | PF-06865571 300 mg + Placebo | 6 | 28 |
| Total, other adverse events | PF-05221304 |15mg Q12H + |PF-06865571 |300mg Q12H | 1 | 28 |
| Total, serious adverse events | Placebo | 0 | 14 |
| Total, serious adverse events | PF-05221304 15mg + Placebo | 0 | 29 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34635855 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03776175
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