Conditions: Non-alcoholic Fatty Liver Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 53
Healthy volunteers: no

Brief summary:
IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE

Detailed description:

Arms:
arm 1: None arm 2: 75 mg once daily arm 3: 300 mg once daily

Interventions: intervention 1: Placebo intervention 2: PF-06835919 Low Dose intervention 3: PF-06835919 High Dose
Intervention descriptions: intervention 1: 0 mg intervention 2: 75 mg once daily intervention 3: 300 mg once daily

Protocol document:
Prot_000.pdf: 
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090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


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090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


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090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


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090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)


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090177e190797888\Approved\Approved On: 06-Mar-2019 06:48 (GMT)

SAP_001.pdf: 
Protocol C1061003 (PF-06835919) Statistical Analysis Plan 
 
 
Page 1 
 
TMF Doc ID: 98.03 
 
 
 
 
 
PROTOCOL C1061003 
 
 
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 
3-ARM, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY, 
TOLERABILITY, AND PHARMACODYNAMICS OF 
PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS IN ADULTS WITH 
NONALCOHOLIC FATTY LIVER DISEASE 
 
 
 
STATISTICAL ANALYSIS PLAN  
(SAP) 
 
 
Version: 
1 
Date:  
07-NOV-2017 
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


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090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


Protocol C1061003 (PF-06835919) Statistical Analysis Plan 
 
 
Page 9 
 
TMF Doc ID: 98.03 
2.5.1. Adverse Events 
For serious adverse events (SAEs), the reporting period to Pfizer or its designated 
representative begins from the time that the subject provides informed consent, which is 
obtained prior to the subject’s participation in the study, ie, prior to undergoing any 
study-related procedure and/or receiving investigational product, through and including 
28 calendar days after the last administration of the investigational product. 
Similarly,the time period for collecting AEs (“active collection period”) for each subject 
begins from the time the subject provides informed consent.  The AEs occurring following 
start of the double-blind randomized treatment will be counted as treatment emergent.  The 
AEs occurring prior to the double-blind randomized treatment intake but during the 
single-blind placebo administration will be listed and summarized as baseline symptoms. 
The 3-Tier approach will not be used to summarize the AEs due to the small size of the 
study. 
2.5.2. Laboratory Data 
Safety laboratory tests will be performed as described in the protocol. 
To determine if there are any clinically significant laboratory abnormalities, the 
haematological, clinical chemistry (serum) and urinalysis safety tests will be assessed against 
the criteria specified in the sponsor reporting standards.  The assessment will take into 
account whether each subject’s baseline test result is within or outside the laboratory 
reference range for the particular laboratory parameter. 
Baseline is defined as the result closest prior to dosing at Visit 5 (Day 1).  
2.5.3. Vitals  
Seated blood pressure and pulse rate measurements will be taken at time points detailed in 
the Schedule of Activities given in the protocol.  
Baseline is defined as the result closest prior to dosing at Visit 5 (Day 1).  The following 
vital signs endpoints will be determined for each subject: 
 The maximum decrease and increase from baseline over all measurements taken post 
dose for systolic and diastolic blood pressures; 
 The maximum increase and decrease from baseline over all measurements taken post 
dose for pulse rate. 
The maximum increase from baseline will be calculated by first subtracting the baseline 
value from each post dose measurement to give the change from baseline.  The maximum of 
these values over the respective period will then be selected, except in the case where a 
subject does not show an increase.  In such an instance, the minimum decrease should be 
taken.  Similarly, the maximum decrease from baseline will be determined by selecting the 
largest negative value of the changes from baseline.  In cases where a subject does not show 
a decrease, the minimum increase should be taken. 
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Protocol C1061003 (PF-06835919) Statistical Analysis Plan 
 
 
Page 14 
 
TMF Doc ID: 98.03 
Figures 
 Whole liver PDFF - A line plot of the model-derived least square means for all 
treatment groups including the placebo group with 90% CI will be provided for 
Week 6 with dose on the X-axis; 
 Whole liver PDFF - Box and whisker plots for individual percent change from 
baseline versus treatment will be presented and overlaid with arithmetic means.  
5.1.2. Sensitivity/Robustness Analyses  
 Analysis endpoint: Whole liver PDFF; 
 Analysis time points: Week 6; 
 Analysis population: Full Analysis set; 
 Analysis methodology: Natural log-transformed individual relative change (RC) from 
baseline to Week 6 in whole liver PDFF will be analyzed using the ANCOVA.  
Log-transformed baseline will be the covariate.  The model will include natural 
log-transformed baseline whole liver PDFF, diabetes status.  Natural log-transformed 
baseline fructose excretion and its interaction with treatment will be considered to be 
included. 
Reporting Results: 
The LSMs and their 90% CI will be exponentiated to provide estimates of the RC which 
will be converted to percent change as follows: 
Percent change = 100* (RC - 1). 
The LSMs of the percent change from baseline with the 90%CIs for each treatment group 
and the LSMs of the percent change from placebo with the 90% CIs for each of the 
PF-06835919 groups and the 2-sided p-values will be presented. 
5.1.3. Supplementary Analysis 
 Analysis endpoint: 9 Segmental PDFFs; 
 Analysis time points: Week 6; 
 Analysis population: Full Analysis set; 
 Analysis methodology: Descriptive statistics. 
Reporting Results: 
 Raw data:  For each of the 9 segmental PDFFs the sample size, mean, standard 
deviation, median, minimum and maximum at baseline and Week 6 visit will be 
presented for each treatment arm; 
090177e19079788b\Approved\Approved On: 06-Mar-2019 06:54 (GMT)


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Any untoward findings identified on physical examinations conducted during the active 
collection period will be captured as AEs, if those findings meet the definition of an AE.  
Data collected at screening that are used for inclusion/exclusion criteria, such as laboratory 
data, ECGs, and vital signs, will be considered source data, and will not be required to be 
reported, unless otherwise noted.  
5.6.1. Adverse Events 
Adverse events will be summarized by treatment and in accordance with current Pfizer data 
standards.  The AEs will be sorted alphabetically within a system organ class.  Summary 
tables will be provided separately for TEAEs and baseline symptoms. 
The 3-Tier approach will not be used to summarize the AEs due to the small sample size. 
5.6.2. Laboratory Data 
All planned, quantitative, standard safety laboratory data presented in Table 6 of the protocol 
and non-standard safety laboratory data that are not reported independently will be listed and 
summarized at each planned collection time point by treatment in accordance with the 
sponsor reporting standards as applicable.  Summary tables will present the number of 
observations, median, minimum and maximum.  Baseline is as defined in Section 2.5.2. 
5.6.3. Vital Signs 
Absolute values and changes from baseline in supine systolic and diastolic blood pressure 
and pulse rate will be summarized by treatment and time postdose, according to sponsor 
reporting standards.  Tables will be paged by parameter.  Baseline is as defined in  
Section 2.5.3. 
Mean changes from baseline for systolic and diastolic blood pressure and pulse rate will be 
plotted against time post doses.  On each plot there will be 1 line for each treatment, all 
treatments on the same plot including the placebo.  Corresponding individual plots of 
changes from baseline will also be produced for each treatment. 
For baseline subtracted seated systolic and diastolic blood pressure and pulse rate, the 
differences between each dose and placebo (dose – placebo) will be summarized (N, mean, 
90% CI) and plotted (mean, 90% CI) for each dose and day.  
Maximum absolute values and maximum changes from baseline for vital signs, over all 
measurements taken post dose will also be tabulated by treatment using categories as defined 
in the Appendix.  Numbers and percentages of subjects meeting the categorical criteria will 
be provided.  All planned and unplanned post dose time points will be counted in these 
categorical summaries.  All values meeting the criteria of potential clinical concern will be 
listed. 
Maximum decrease and increase from baseline for seated systolic and diastolic blood 
pressures, and maximum increase from baseline for seated pulse rate will be summarized by 
treatment, according to sponsor reporting standards. 
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Changes from baseline in vital signs will also be plotted separately against drug 
concentrations for each time point of collection (Weeks 2, 4 and 6).  These will be scatter 
plots for all observations where vital signs and drug concentration are recorded.  Placebo data 
will also be included (with drug concentration set to zero).  Different symbols will be used 
for each treatment. 
5.6.4. Electrocardiogram 
Absolute values and changes from baseline in QT, heart rate, QTcF, PR, RR and QRS will be 
summarized by treatment and day using sponsor reporting standards.  Tables will be paged 
by parameter.  Baseline is as defined in Section 2.5.4. 
Mean changes from baseline in QT, heart rate and QTcF will be plotted against time 
postdose.  On each plot there will be 1 line for each treatment, all treatments on the same plot 
including the placebo.  Corresponding individual plots of changes from baseline will also be 
produced for each treatment. 
In addition for baseline subtracted QT, heart rate and QTcF, the differences between each 
dose and placebo (dose – placebo) will be summarized (N, mean, 90% CI) and plotted 
(mean) for each dose and day (Weeks 2, 4, 6 and follow-up). 
Changes from baseline in QTcF will also be plotted separately against drug concentrations 
for each time point of collection (Weeks 2, 4 and 6).  These will be scatter plots for all 
observations where QTcF and drug concentration are recorded.  Placebo data will also be 
included (with drug concentration set to zero).  Different symbols will be used for each 
treatment. 
ECG endpoints and changes from baseline (QTcF, PR and QRS) will also be summarized 
descriptively by treatment using categories as defined in the Appendix (for QTc these 
correspond to ICH E14).  Numbers and percentages of subjects meeting the categorical 
criteria will be provided.  All planned and unplanned postdose timepoints will be counted in 
these categorical summaries.  All values meeting the criteria of potential clinical concern will 
be listed. 
Maximum absolute value (post dose) and the maximum increase from baseline for QTcF, PR 
and QRS will be summarized by treatment according to sponsor reporting standards.  
Listings of subjects with any single post dose value 500 msec will also be produced for 
QTcF.  
6. INTERIM ANALYSES 
No interim analysis will be conducted in this study. 
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7. REFERENCES  
1. 
McGill, R., John W. Tukey and W. A. Larsen. 1978. "Variations of Box Plots." 
American Statistician 32:12-16 
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8. APPENDIX 
Categorical Classes for ECG and Vital Signs  
Categories for QTcF 
QTcF (ms) 
450≤ max. <480 
480≤ max.<500 
max. ≥500 
QTcF (ms) 
increase from 
baseline 
30≤ max. <60 
max. ≥60 
 
 
Categories for PR and QRS 
PR (ms) 
max. ≥300 
 
PR (ms) increase 
from baseline 
Baseline 
>200 and max. 
≥25% increase 
Baseline ≤200 and 
max. ≥50% 
increase 
QRS (ms) 
max. ≥140 
 
QRS (ms) 
increase from 
baseline 
≥50% increase 
 
 
Categories for Vital Signs 
Systolic BP (mm Hg) 
min. <90 
 
Systolic BP (mm Hg) 
change from baseline 
max. decrease ≥30 
max. increase ≥30 
Diastolic BP (mm Hg) 
min. <50 
 
Diastolic BP (mm Hg) 
change from baseline 
max. decrease ≥20 
max. increase ≥20 
Seated pulse rate (bpm) 
min. <40 
max. >120 
 
 Measurements that fulfill these criteria are to be listed in the report. 
 
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