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CompletedNCT02554877Updated Aug 7, 2017Results posted

A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On Metformin

A Phase 2 interventional study of PF-06291874 and Placebo in Type 2 Diabetes Mellitus, sponsored by Pfizer. Completed at 38 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-08-07.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether PF-06291874 is effective in the treatment T2DM

Read the detailed description

This will be a randomized, double blind, stratified, placebo controlled, parallel group study conducted in T2DM subjects receiving background metformin therapy. Subjects will complete screening procedures to determine eligibility, followed by an 8 week metformin stabilization period prior to randomization. In addition, subjects taking other OADs, in combination with metformin, will undergo a washout during this period, in which non metformin OAD medications will be temporarily discontinued for the duration of the trial. Following confirmation of study eligibility criteria at randomization, subjects will be stratified into 2 groups based on the use of concomitant statin therapy. Each stratum will be randomized across treatment groups, such that the number of subjects taking concomitant statin therapy and those not taking statin therapy will be approximately balanced across treatment groups.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 206 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males or non-childbearing potential females between the ages of 18 (or the minimum country specific age of consent if >18) and 70 years, inclusive, at the screening visit (V1) with the diagnosis of T2DM;Female subjects who are not of childbearing potential
  2. Subjects who have been on a stable dose of metformin either alone or in combination with one additional acceptable OAD
  3. HbA1c at the Screen Visit (V1), as assessed by study specific central laboratory, is 7-11% if on metformin monotherapy; is 6.5-9.5% if on dual combination therapy (metformin plus 1)

Exclusion criteria

Exclusion Criteria:

  1. Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;
  2. Fasting plasma glucose levels >270 mg/dL (15.0 mmol/L) at the screening and run in visit, (as assessed by study specific central laboratory) confirmed by a single repeat, if deemed necessary
  3. History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class III IV heart failure, or transient ischemic attack within 6 months of screening;
  4. Any medical condition possibly affecting study drug absorption (eg, gastrectomy or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency
  5. Subjects with a creatinine clearance \<60 mL/min as determined by the Cockcroft Gault equation (listed below) using serum creatinine measured at screening, confirmed via a single repeat, if deemed necessary
  6. Subject with a positive result for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Ab) or hepatitis C virus (HCV) antibodies
  7. Screening seated systolic blood pressure >160 mm Hg and/or diastolic blood pressure >105 mm Hg after at least a 5 minute rest. Blood pressure determined as the mean of triplicate measurements collected with approximately 2 minutes of rest between measurements
  8. Screening supine 12 lead ECG demonstrating a corrected QT (QTc) >470 msec; or a QRS interval >120 msec. If QTc exceeds 470 msec or QRS exceeds 120 msec, the ECG may be repeated 2 more times with an interval of 2-4 minutes between each measurement and the mean of the 3 values used to determine the subject's eligibility
  9. Subjects with an arm circumference >52 cm measured at the midpoint of the length of the upper arm;
  10. History (within the last 6 months) of regular alcohol consumption exceeding 14 drinks per week for men and 7 drinks a week for women. (1 drink = 5 ounces of wine (150 mL) or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor);
  11. Treatment with thiazolidinediones (TZDs), or subcutaneously administered anti diabetic agents (eg, insulin, exenatide, liraglutide, pramlintide) within 6 weeks prior to V1;
  12. Subjects with a known hypersensitivity or intolerance to a glucagon receptor antagonist, or known prior participation in a trial involving PF 06291874;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
206 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    PF-06291874, 30 mg

    Drug: PF-06291874

  • Experimental
    PF-06291874, 60 mg

    Drug: PF-06291874

  • Experimental
    PF-06291874, 100 mg

    Drug: PF-06291874

Interventions

  • DrugPF-06291874

    study drug to be given as an oral tablet at 30, 60 or 100 mg

  • DrugPlacebo

    oral tablet

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo

    HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study.

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Change From Baseline in HbA1c (%) at Weeks 2, 4, and 8

    HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study. n represented the available number of participants for analysis at post-baseline days.

    Time frame: Baseline, Weeks 2, 4, 8

  2. Change From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12

    Fasting plasma glucose response changed from baseline at Weeks 2,4,8 and 12. Baseline was defined as the average of the measurements obtained during Day 14 visit window and Day 1 pre-dose measurement. n represented the available number of participants for analysis at post-baseline days.

    Time frame: Baseline, Weeks 2,4,8 and 12

  3. Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) <7% as Well as <6.5% at Week 12.

    HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time.

    Time frame: Week 12

  4. Number of Participants With Laboratory Test Abnormalities

    The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.

    Time frame: Baseline up to 98 days

  5. Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria

    ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): \>=140 milliseconds (msec); \>=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): \>=300 msec; \>=25 percent (%) increase when baseline \>200 msec; or increase \>=50% when baseline less than or equal to (\<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): absolute value \>=450 - \<480 msec, \>=480-\<500 msec, \>=500 msec; increase from baseline \>=30 - \<60, \>=60 msec.

    Time frame: Baseline up to Day 98

  6. Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria

    Vital signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (\>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (\<) 90 mm Hg; diastolic BP (DBP) \>=20 mm Hg change from baseline, diastolic \<50 mm Hg; 2), pulse rate \<40 or greater than (\>) 120 beats per minute (bpm).

    Time frame: Baseline up to Day 98

  7. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Hypoglycemic Adverse Events (HAEs).

    An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug; the event need not necessarily have a causal relationship with the treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reasons: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. Any events occurring following start of treatment (defined as blinded therapy, including single blind placebo administration on Day 14) or increasing in severity were counted as treatment emergent AE.

    Time frame: Baseline up to Day 119

  8. Percent Changes From Baseline for Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Weeks 2, 4, 8 and 12

    Fasting low density lipoprotein-cholesterol (LDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.

    Time frame: Baseline, Weeks 2, 4, 8 and 12

  9. Percent Changes From Baseline for Triglycerides at Weeks 2, 4, 8 and 12

    Triglycerides percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days. Triglycerides MMRM was not appropriate as the data were very skewed and not normally distributed, therefore per SAP non-parametric analysis were reported, presenting medians and CIs for medians, instead. If the data had many outliers even after the log transformation the following non parametric analysis was presented instead of the MMRM. An outlier was defined as any data point falling outside of 3.5 x standard deviations the median.

    Time frame: Baseline, Weeks 2, 4, 8 and 12

  10. Percent Changes From Baseline for Total Cholesterol at Weeks 2, 4, 8 and 12

    Total cholesterol percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.

    Time frame: Baseline, Weeks 2, 4, 8 and 12

  11. Percent Changes From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Weeks 2, 4, 8 and 12

    High density lipoprotein-cholesterol (HDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.

    Time frame: Baseline, Weeks 2, 4, 8 and 12

  12. Percent Changes From Baseline for Non-High Density Lipoprotein (HDL) Cholesterol at Weeks 2, 4, 8 and 12

    Non-HDL-C percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.

    Time frame: Baseline, Weeks 2, 4, 8 and 12

  13. Changes From Baseline in Body Weight at Weeks 2, 4, 8, and 12.

    The body weight change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.

    Time frame: Baseline, Weeks 2, 4, 8 and 12

07

Results

Posted Aug 7, 2017

Participant flow

Participant flow — Overall Study
MilestonePlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Started51515252
Completed39444645
Not completed12767
Withdrew: Adverse event2001
Withdrew: Lost to follow-up1112
Withdrew: Did not meet entrance criteria0010
Withdrew: No longer met eligibility criteria1011
Withdrew: Protocol violation3110
Withdrew: Other1303
Withdrew: Insufficient clinical response4000
Withdrew: No longer willing to participate0220

Outcome measures

PrimaryChange From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo

HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study.

Time frame:
Baseline, Week 12
Reported as:
Mean · percentage of HbA1c
Change From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo
percentage of HbA1cPlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Change From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo0.18 ± 0.834-0.68 ± 0.778-0.91 ± 0.765-0.92 ± 0.809
Statistical analysis
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = <0.0001 (Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -0.91 · 95% CI -1.34 to -0.48
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = <0.0001 (Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -1.16 · 95% CI -1.59 to -0.73
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = <0.0001 (Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -1.17 · 95% CI -1.60 to -0.74
SecondaryChange From Baseline in HbA1c (%) at Weeks 2, 4, and 8

HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study. n represented the available number of participants for analysis at post-baseline days.

Time frame:
Baseline, Weeks 2, 4, 8
Reported as:
Mean · percentage of HbA1c
Change From Baseline in HbA1c (%) at Weeks 2, 4, and 8
percentage of HbA1cPlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Week 2 HbA1c(%)Change from Baseline(n=46,48,48,47)0.10 ± 0.363-0.30 ± 0.383-0.30 ± 0.341-0.31 ± 0.260
Week 4 HbA1c(%)Change from Baseline(n=45,47,47,47)0.12 ± 0.426-0.53 ± 0.546-0.57 ± 0.444-0.49 ± 0.371
Week 8 HbA1c(%)Change from Baseline(n=40,45,47,45)0.15 ± 0.653-0.65 ± 0.617-0.90 ± 0.612-0.82 ± 0.512
Statistical analysis
  • Placebo vs PF-06291874 30 mg · ANCOVA · p = <0.0001 (Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects) · Ls mean difference from placebo: -0.39 · 95% CI -0.52 to -0.26Least squares mean (LS mean) difference from placebo adjusted for baseline values was derived from the ANCOVA model
  • Placebo vs PF-06291874 60 mg · ANCOVA · p = <0.0001 (Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects) · Ls mean difference from placebo: -0.39 · 95% CI -0.52 to -0.26LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.
  • Placebo vs PF-06291874 100 mg · ANCOVA · p = <0.0001 (Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.) · Ls mean difference from placebo: -0.44 · 95% CI -0.57 to -0.30LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.
  • Placebo vs PF-06291874 30 mg · ANCOVA · p = <0.0001 (Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.) · Ls mean difference from placebo: -0.59 · 95% CI -0.76 to -0.42LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.
  • Placebo vs PF-06291874 60 mg · ANCOVA · p = <0.0001 (Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.) · Ls mean difference from placebo: -0.63 · 95% CI -0.80 to -0.46LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.
  • Placebo vs PF-06291874 100 mg · ANCOVA · p = <0.0001 (Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.) · Ls mean difference from placebo: -0.62 · 95% CI -0.79 to -0.46LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.
  • Placebo vs PF-06291874 30 mg · ANCOVA · p = <0.0001 (Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.) · Ls mean difference from placebo: -0.71 · 95% CI -0.93 to -0.49LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model
  • Placebo vs PF-06291874 60 mg · ANCOVA · p = <0.0001 (Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects..) · Ls mean difference from placebo: -0.96 · 95% CI -1.17 to -0.74LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.
  • Placebo vs PF-06291874 100 mg · ANCOVA · p = <0.0001 (Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.) · Ls mean difference from placebo: -0.98 · 95% CI -1.20 to -0.76LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.
SecondaryChange From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12

Fasting plasma glucose response changed from baseline at Weeks 2,4,8 and 12. Baseline was defined as the average of the measurements obtained during Day 14 visit window and Day 1 pre-dose measurement. n represented the available number of participants for analysis at post-baseline days.

Time frame:
Baseline, Weeks 2,4,8 and 12
Reported as:
Mean · mg/dL
Change From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12
mg/dLPlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Week 2 Change from Baseline(n=49,48,48,47)11.0 ± 28.5-25.2 ± 26.95-32.4 ± 35.31-32.5 ± 32.26
Week 4 Change from Baseline(n=45,47,47,47)3.4 ± 29.22-26.8 ± 29.68-34.7 ± 39.15-30.9 ± 32.55
Week 8 Change from Baseline(n=39,44,47,45)-1.8 ± 42.57-19.9 ± 35.93-35.4 ± 32.5-31.8 ± 26.57
Week 12 Change from Baseline(n=39,43,46,45)-0.6 ± 31.64-18.5 ± 30.19-32.8 ± 35.24-31.9 ± 35.56
Statistical analysis
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = <0.0001 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -37.83 · 95% CI -47.96 to -27.70
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = <0.0001 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -44.85 · 95% CI -54.98 to -34.72
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = <0.0001 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -48.59 · 95% CI -58.81 to -38.37
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = <0.0001 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -30.63 · 95% CI -42.52 to -18.74
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = <0.0001 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -39.24 · 95% CI -51.13 to -27.35
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = <0.0001 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -38.30 · 95% CI -50.22 to -26.38
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.0023 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -19.47 · 95% CI -31.88 to -7.05
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = <0.0001 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -36.98 · 95% CI -49.27 to -24.69
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = <0.0001 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -35.14 · 95% CI -47.55 to -22.72
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.0014 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -19.77 · 95% CI -31.81 to -7.73
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = <0.0001 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -35.26 · 95% CI -47.17 to -23.35
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = <0.0001 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -36.44 · 95% CI -48.43 to -24.46
SecondaryPercentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) <7% as Well as <6.5% at Week 12.

HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time.

Time frame:
Week 12
Reported as:
Number · % (percentage of participants)
Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) <7% as Well as <6.5% at Week 12.
% (percentage of participants)PlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
HbA1c <6.5%5.13 (0.63 to 17.32)11.36 (3.79 to 24.56)13.04 (4.94 to 26.26)22.22 (11.20 to 37.09)
HbA1c <7%15.38 (5.86 to 30.53)29.55 (16.76 to 45.20)34.78 (21.35 to 50.25)55.56 (40.00 to 70.36)
Statistical analysis
  • Placebo vs PF-06291874 30 mg · Regression, Logistic · p = 0.0059 (P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.) · Odds ratio (or): 6.057 · 95% CI 1.68 to 21.82
  • Placebo vs PF-06291874 60 mg · Regression, Logistic · p = 0.0008 (P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.) · Odds ratio (or): 8.927 · 95% CI 2.49 to 31.96
  • Placebo vs PF-06291874 100 mg · Regression, Logistic · p = <0.0001 (P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.) · Odds ratio (or): 15.116 · 95% CI 4.34 to 52.67
  • Placebo vs PF-06291874 30 mg · Regression, Logistic · p = 0.1532 (P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.) · Odds ratio (or): 3.340 · 95% CI 0.64 to 17.47
  • Placebo vs PF-06291874 60 mg · Regression, Logistic · p = 0.0826 (P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.) · Risk ratio (rr): 4.198 · 95% CI 0.83 to 21.22
  • Placebo vs PF-06291874 100 mg · Regression, Logistic · p = 0.0272 (P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.) · Odds ratio (or): 5.588 · 95% CI 1.21 to 25.73
SecondaryNumber of Participants With Laboratory Test Abnormalities

The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.

Time frame:
Baseline up to 98 days
Reported as:
Number · participants
Number of Participants With Laboratory Test Abnormalities
participantsPlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Number of Participants With Laboratory Test Abnormalities49424038
SecondaryNumber of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria

ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): \>=140 milliseconds (msec); \>=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): \>=300 msec; \>=25 percent (%) increase when baseline \>200 msec; or increase \>=50% when baseline less than or equal to (\<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): absolute value \>=450 - \<480 msec, \>=480-\<500 msec, \>=500 msec; increase from baseline \>=30 - \<60, \>=60 msec.

Time frame:
Baseline up to Day 98
Reported as:
Number · participants
Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria
participantsPlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Maximum PR interval >=300 msec0000
Maximum QRS interval >=140 msec0001
Maximum QTcF interval 450-<480 msec4422
Maximum PR interval increase >=25%/50%0011
Maximum QRS complex increase >=50%1000
Maximum QTcF interval increase 30<=-<60 msec1035
Maximum QTcF interval increase >=60 msec0100
Maximum QTcF interval 480-<500 msec0000
Maximum QTcF interval >=500 msec0000
SecondaryNumber of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria

Vital signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (\>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (\<) 90 mm Hg; diastolic BP (DBP) \>=20 mm Hg change from baseline, diastolic \<50 mm Hg; 2), pulse rate \<40 or greater than (\>) 120 beats per minute (bpm).

Time frame:
Baseline up to Day 98
Reported as:
Number · participants
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
participantsPlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Sitting SBP <90 mm Hg1000
Sitting DBP <50mm Hg1000
Sitting Pulse Rate <40 bpm0000
Sitting Pulse Rate >120 bpm0000
Increase: Sitting SBP >=30 mm Hg0314
Increase: Sitting Systolic BP >=20 mm Hg0103
Decrease: Sitting SBP >=30 mm Hg1210
Decrease: Sitting SBP >=20 mm Hg0010
SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Hypoglycemic Adverse Events (HAEs).

An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug; the event need not necessarily have a causal relationship with the treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reasons: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. Any events occurring following start of treatment (defined as blinded therapy, including single blind placebo administration on Day 14) or increasing in severity were counted as treatment emergent AE.

Time frame:
Baseline up to Day 119
Reported as:
Number · participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Hypoglycemic Adverse Events (HAEs).
participantsPlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
AEs22201827
SAEs2102
HAEs5112
SecondaryPercent Changes From Baseline for Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Weeks 2, 4, 8 and 12

Fasting low density lipoprotein-cholesterol (LDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.

Time frame:
Baseline, Weeks 2, 4, 8 and 12
Reported as:
Mean · % (percent change)
Percent Changes From Baseline for Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Weeks 2, 4, 8 and 12
% (percent change)PlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Week 2 Percent Change from Baseline(n=49,47,48,47)0.68 ± 16.301-1.41 ± 17.832-0.64 ± 17.1542.16 ± 16.846
Week 4 Percent Change from Baseline(n=45,47,47,47)3.29 ± 18.4850.46 ± 12.752-0.62 ± 18.522-2.07 ± 15.170
Week 8 Percent Change from Baseline(n=40,45,47,45)5.31 ± 21.2442.17 ± 15.5031.32 ± 17.4481.92 ± 17.030
Week12 Percent Change from Baseline(n=39,43,46,45)0.13 ± 18.6801.77 ± 17.2784.20 ± 18.3151.16 ± 19.061
Statistical analysis
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.7618 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -1.03 · 90% CI -6.66 to 4.59
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.8489 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -0.65 · 90% CI -6.25 to 4.96
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.4699 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 2.47 · 90% CI -3.17 to 8.12
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.4979 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -2.22 · 90% CI -7.63 to 3.19
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.2927 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -3.45 · 90% CI -8.85 to 1.95
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.1430 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -4.83 · 90% CI -10.26 to 0.60
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.7373 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -1.25 · 90% CI -7.42 to 4.92
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.5075 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -2.46 · 90% CI -8.57 to 3.66
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.6295 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -1.81 · 90% CI -7.99 to 4.37
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.4266 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 3.15 · 90% CI -3.39 to 9.69
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.2038 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 4.96 · 90% CI -1.47 to 11.40
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.5592 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 2.29 · 90% CI -4.19 to 8.78
SecondaryPercent Changes From Baseline for Triglycerides at Weeks 2, 4, 8 and 12

Triglycerides percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days. Triglycerides MMRM was not appropriate as the data were very skewed and not normally distributed, therefore per SAP non-parametric analysis were reported, presenting medians and CIs for medians, instead. If the data had many outliers even after the log transformation the following non parametric analysis was presented instead of the MMRM. An outlier was defined as any data point falling outside of 3.5 x standard deviations the median.

Time frame:
Baseline, Weeks 2, 4, 8 and 12
Reported as:
Median · % (percent change)
Percent Changes From Baseline for Triglycerides at Weeks 2, 4, 8 and 12
% (percent change)PlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Week 2 Percent Change from Baseline(n=49,48,48,47)5.45 (-56.7 to 126.3)10.55 (-44.0 to 138.5)8.32 (-32.6 to 189.0)22.58 (-37.5 to 144.7)
Week 4 Percent Change from Baseline(n=44,47,47,47)3.74 (-59.0 to 224.1)6.45 (-48.2 to 121.4)6.67 (-44.8 to 169.8)1.18 (-35.7 to 107.2)
Week 8 Percent Change from Baseline(n=40,45,47,45)6.72 (-37.7 to 155.2)5.08 (-36.9 to 103.9)2.13 (-52.1 to 178.1)9.47 (-49.3 to 140.0)
Week12 Percent Change from Baseline(n=39,44,46,45)-0.72 (-38.4 to 154.0)7.13 (-47.7 to 186.7)-1.85 (-48.0 to 147.8)5.26 (-47.9 to 112.6)
Statistical analysis
  • Placebo vs PF-06291874 30 mg · Median difference (net): 5.09 · 90% CI -5.86 to 16.05
  • Placebo vs PF-06291874 60 mg · Median difference (net): 2.86 · 90% CI -9.76 to 15.48
  • Placebo vs PF-06291874 100 mg · Median difference (net): 17.13 · 90% CI 3.91 to 30.34
  • Placebo vs PF-06291874 30 mg · Median difference (net): 2.71 · 90% CI -10.80 to 16.22
  • Placebo vs PF-06291874 60 mg · Median difference (net): 2.92 · 90% CI -10.61 to 16.45
  • Placebo vs PF-06291874 100 mg · Median difference (net): -2.57 · 90% CI -15.08 to 9.94
  • Placebo vs PF-06291874 30 mg · Median difference (net): -1.63 · 90% CI -16.29 to 13.03
  • Placebo vs PF-06291874 60 mg · Median difference (net): -4.59 · 90% CI -20.40 to 11.22
  • Placebo vs PF-06291874 100 mg · Median difference (net): 2.75 · 90% CI -13.66 to 19.16
  • Placebo vs PF-06291874 30 mg · Median difference (net): 7.86 · 90% CI -3.30 to 19.02
  • Placebo vs PF-06291874 60 mg · Median difference (net): -1.13 · 90% CI -16.13 to 13.87
  • Placebo vs PF-06291874 100 mg · Median difference (net): 5.99 · 90% CI -7.07 to 19.04
SecondaryPercent Changes From Baseline for Total Cholesterol at Weeks 2, 4, 8 and 12

Total cholesterol percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.

Time frame:
Baseline, Weeks 2, 4, 8 and 12
Reported as:
Mean · % (percent change)
Percent Changes From Baseline for Total Cholesterol at Weeks 2, 4, 8 and 12
% (percent change)PlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Week 2 Percent Change from Baseline(n=49,48,48,47)0.16 ± 11.8630.39 ± 12.6061.02 ± 12.0584.05 ± 13.900
Week 4 Percent Change from Baseline(n=44,47,47,47)2.65 ± 14.6421.69 ± 8.7630.36 ± 13.7320.44 ± 11.674
Week 8 Percent Change from Baseline(n=40,45,47,45)3.30 ± 14.3541.53 ± 10.569-0.11 ± 12.6922.77 ± 10.860
Week12 Percent Change from Baseline(n=39,44,46,45)-0.87 ± 13.2382.28 ± 12.2603.00 ± 13.9522.03 ± 13.986
Statistical analysis
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.6800 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 1.04 · 90% CI -3.12 to 5.20
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.5150 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix) · Ls mean difference from placebo: 1.64 · 90% CI -2.52 to 5.80
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.0676 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix) · Ls mean difference from placebo: 4.66 · 90% CI 0.47 to 8.85
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.8021 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix) · Ls mean difference from placebo: -0.62 · 90% CI -4.73 to 3.48
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.4346 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix) · Ls mean difference from placebo: -1.95 · 90% CI -6.06 to 2.16
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.4173 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix) · Ls mean difference from placebo: -2.03 · 90% CI -6.15 to 2.09
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.7036 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix) · Ls mean difference from placebo: -0.98 · 90% CI -5.21 to 3.26
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.2993 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix) · Ls mean difference from placebo: -2.64 · 90% CI -6.84 to 1.56
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.9751 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix) · Ls mean difference from placebo: 0.08 · 90% CI -4.16 to 4.32
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.1408 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix) · Ls mean difference from placebo: 4.23 · 90% CI -0.50 to 8.96
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.0986 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix) · Ls mean difference from placebo: 4.70 · 90% CI 0.02 to 9.38
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.1851 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix) · Ls mean difference from placebo: 3.79 · 90% CI -0.92 to 8.50
SecondaryPercent Changes From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Weeks 2, 4, 8 and 12

High density lipoprotein-cholesterol (HDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.

Time frame:
Baseline, Weeks 2, 4, 8 and 12
Reported as:
Mean · % (percent change)
Percent Changes From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Weeks 2, 4, 8 and 12
% (percent change)PlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Week 2 Percent Change from Baseline(n=49,48,48,47)-0.14 ± 8.0860.08 ± 9.3452.60 ± 10.7398.13 ± 13.554
Week 4 Percent Change from Baseline(n=44,47,47,47)0.51 ± 11.3910.79 ± 10.6263.98 ± 14.2888.16 ± 11.776
Week 8 Percent Change from Baseline(n=40,45,47,45)-1.91 ± 11.7361.24 ± 10.2922.15 ± 10.7247.71 ± 13.768
Week12 Percent Change from Baseline(n=39,44,46,45)-2.62 ± 13.2373.65 ± 12.8894.51 ± 10.5987.57 ± 15.226
Statistical analysis
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.8559 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.39 · 90% CI -3.19 to 3.98
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.1729 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 2.97 · 90% CI -0.62 to 6.55
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.0002 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 8.45 · 90% CI 4.84 to 12.06
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.8837 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.37 · 90% CI -3.85 to 4.59
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.1573 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 3.62 · 90% CI -0.60 to 7.84
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.0024 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 7.88 · 90% CI 3.65 to 12.11
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.1538 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 3.59 · 90% CI -0.55 to 7.73
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.0789 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 4.39 · 90% CI 0.28 to 8.49
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = <0.0001 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 10.14 · 90% CI 5.98 to 14.30
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.0132 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 6.96 · 90% CI 2.36 to 11.56
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.0079 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 7.41 · 90% CI 2.85 to 11.96
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.0001 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 10.83 · 90% CI 6.24 to 15.42
SecondaryPercent Changes From Baseline for Non-High Density Lipoprotein (HDL) Cholesterol at Weeks 2, 4, 8 and 12

Non-HDL-C percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.

Time frame:
Baseline, Weeks 2, 4, 8 and 12
Reported as:
Mean · % (percent change)
Percent Changes From Baseline for Non-High Density Lipoprotein (HDL) Cholesterol at Weeks 2, 4, 8 and 12
% (percent change)PlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Week 2 Percent Change from Baseline(n=49,48,48,47)0.51 ± 16.1951.00 ± 16.6750.63 ± 14.8702.73 ± 18.427
Week 4 Percent Change from Baseline(n=44,47,47,47)4.18 ± 21.4861.88 ± 11.961-0.47 ± 17.972-2.40 ± 13.877
Week 8 Percent Change from Baseline(n=40,45,47,45)5.24 ± 19.2221.76 ± 14.128-0.52 ± 16.0140.88 ± 13.765
Week12 Percent Change from Baseline(n=39,44,46,45)-0.48 ± 16.7112.09 ± 16.4512.67 ± 18.098-0.25 ± 17.666
Statistical analysis
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.6597 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 1.46 · 90% CI -4.01 to 6.92
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.7583 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 1.02 · 90% CI -4.45 to 6.49
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.3516 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 3.11 · 90% CI -2.39 to 8.61
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.5877 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -1.83 · 90% CI -7.42 to 3.75
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.2016 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -4.33 · 90% CI -9.92 to 1.26
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.0568 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -6.49 · 90% CI -12.08 to -0.89
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.3827 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -2.94 · 90% CI -8.48 to 2.61
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.1126 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -5.31 · 90% CI -10.81 to 0.20
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.2160 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: -4.17 · 90% CI -9.73 to 1.38
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.3443 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 3.54 · 90% CI -2.64 to 9.72
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.3031 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 3.82 · 90% CI -2.30 to 9.94
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.8129 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.88 · 90% CI -5.27 to 7.04
SecondaryChanges From Baseline in Body Weight at Weeks 2, 4, 8, and 12.

The body weight change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.

Time frame:
Baseline, Weeks 2, 4, 8 and 12
Reported as:
Mean · kg
Changes From Baseline in Body Weight at Weeks 2, 4, 8, and 12.
kgPlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Week 2 Change from Baseline(n=49,48,48,47)-0.15 ± 1.3470.15 ± 1.234-0.15 ± 1.2530.65 ± 3.342
Week 4 Change from Baseline(n=45,47,47,47)-0.76 ± 3.3020.55 ± 1.2310.28 ± 1.2190.56 ± 2.925
Week 8 Change from Baseline(n=41,45,47,45)-0.61 ± 1.5170.44 ± 1.6940.26 ± 1.7750.55 ± 2.786
Week 12 Change from Baseline(n=39,44,46,45)-0.79 ± 1.8920.49 ± 2.1190.31 ± 2.1350.41 ± 3.216
Statistical analysis
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.4020 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.34 · 90% CI -0.33 to 1.01
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.8789 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.06 · 90% CI -0.61 to 0.73
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.0345 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.87 · 90% CI 0.19 to 1.54
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.0087 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 1.28 · 90% CI 0.48 to 2.08
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.0268 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 1.08 · 90% CI 0.28 to 1.88
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.0047 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 1.39 · 90% CI 0.58 to 2.19
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.0116 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 1.07 · 90% CI 0.38 to 1.76
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.0220 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.97 · 90% CI 0.27 to 1.66
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.0021 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 1.31 · 90% CI 0.62 to 2.01
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.0067 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 1.41 · 90% CI 0.56 to 2.26
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.0225 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 1.18 · 90% CI 0.33 to 2.02
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.0073 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 1.40 · 90% CI 0.55 to 2.25
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.2391 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.30 · 90% CI -0.12 to 0.73
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.9912 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.00 · 90% CI -0.42 to 0.43
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.1930 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.34 · 90% CI -0.09 to 0.77
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.0038 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.80 · 90% CI 0.35 to 1.25
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.0394 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.57 · 90% CI 0.12 to 1.02
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.0862 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.48 · 90% CI 0.02 to 0.93
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.0024 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 1.05 · 90% CI 0.48 to 1.61
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.0068 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.92 · 90% CI 0.37 to 1.48
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.0132 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.86 · 90% CI 0.29 to 1.42
  • Placebo vs PF-06291874 30 mg · Mixed Models Analysis · p = 0.0024 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 1.39 · 90% CI 0.65 to 2.14
  • Placebo vs PF-06291874 60 mg · Mixed Models Analysis · p = 0.0115 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 1.15 · 90% CI 0.40 to 1.89
  • Placebo vs PF-06291874 100 mg · Mixed Models Analysis · p = 0.0344 (Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.) · Ls mean difference from placebo: 0.97 · 90% CI 0.22 to 1.72

Adverse events

Collected over Baseline up to Day 119. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—2/51 (3.9%)6/51 (11.8%)
PF-06291874 30 mg—1/51 (2%)5/51 (9.8%)
PF-06291874 60 mg—0/52 (0%)2/52 (3.8%)
PF-06291874 100 mg—2/52 (3.8%)7/52 (13.5%)
Most frequent serious events
Most frequent serious events
EventPlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Cholecystitis acuteHepatobiliary disorders1/510/510/520/52
Brain neoplasm benignNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/510/510/520/52
Adjustment disorderPsychiatric disorders0/511/510/520/52
Gastritis erosiveGastrointestinal disorders0/510/510/521/52
AbscessInfections and infestations0/510/510/521/52
Most frequent other events
Most frequent other events
EventPlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mg
Urinary tract infectionInfections and infestations4/512/512/524/52
Upper respiratory tract infectionInfections and infestations3/513/510/523/52

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mgTotal
Mean56.6 ± 6.358.1 ± 6.957.1 ± 7.157.4 ± 7.957.3 ± 7
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboPF-06291874 30 mgPF-06291874 60 mgPF-06291874 100 mgTotal
Female2220242187
Male29312831119
08

Study locations

38 sites
  • Anaheim Clinical Trials, LLC
    Anaheim, California 92801, United States
  • National Research Institute
    Los Angeles, California 90057, United States
  • NRC Research Institute
    Orange, California 92868, United States
  • Sierra Clinical Research
    Roseville, California 95661, United States
  • Encompass Clinical Research
    Spring Valley, California 91978, United States
  • Empire Clinical Research
    Upland, California 91786, United States
  • Diablo Clinical Research, Inc
    Walnut Creek, California 94598, United States
  • Clinical Research of South Florida
    Coral Gables, Florida 33134, United States
  • Avail Clinical Research, LLC
    DeLand, Florida 32720, United States
  • Suncoast Research Group, Llc
    Miami, Florida 33135, United States
  • QPS-MRA, LLC (Miami Research Associates)
    South Miami, Florida 33143, United States
  • Palm Beach Research Center
    West Palm Beach, Florida 33409, United States
  • WR-Mount Vernon Clinical Research, LLC
    Sandy Springs, Georgia 30328, United States
  • East-West Medical Research Institute
    Honolulu, Hawaii 96814, United States
  • Midwest Institute for Clinical Research
    Indianapolis, Indiana 46260, United States
  • Crescent City Clinical Research Center, LLC
    Metairie, Louisiana 70006, United States
  • St. Louis Clinical Trials, LC
    St Louis, Missouri 63141, United States
  • ALAS Science Clinical Research
    Las Vegas, Nevada 89120, United States
  • Comprehensive Clinical Research
    Berlin, New Jersey 08009, United States
  • Clinilabs Inc.
    Eatontown, New Jersey 07724, United States
  • Pharmaceutical Research Associates, Inc.
    Marlton, New Jersey 08053, United States
  • TLB Research
    Trenton, New Jersey 08611, United States
  • Randolph Medical Associates
    Asheboro, North Carolina 27203, United States
  • High Point Clinical Trials Center, LLC
    High Point, North Carolina 27265, United States
  • Lillestol Research, LLC
    Fargo, North Dakota 58103, United States
  • Aventiv Research
    Columbus, Ohio 43213, United States
  • Juno Research, LLC
    Houston, Texas 77074, United States
  • Texas Center for Drug Development, Inc.
    Houston, Texas 77081, United States
  • Juno Research, LLC
    Katy, Texas 77450, United States
  • Clinical Trials of Texas, Inc.
    San Antonio, Texas 78229, United States
  • Northeast Clinical Research of San Antonio, LLC
    Schertz, Texas 78154, United States
  • National Clinical Research - Richmond, Inc.
    Richmond, Virginia 23294, United States
  • Aggarwal and Associates Limited
    Brampton, Ontario L6T 0G1, Canada
  • LMC Clinical Research Inc. (Thornhill)
    Thornhill, Ontario L4J 8L7, Canada
  • LMC Clinical Research Inc. (Bayview)
    Toronto, Ontario M4G 3E8, Canada
  • Manna Research
    Toronto, Ontario M9W 4L6, Canada
  • Manna Research Inc.
    Lévis, Quebec G6W 0M6, Canada
  • Omnispec Clinical Research, Inc.
    Mirabel, Quebec J7J 2K8, Canada
09

References and documents

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2015, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.

Results were first posted in Aug 2017, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2015
First posted
Sep 18, 2015
Start
Oct 2015
Primary completionActual
Aug 2016
CompletionActual
Aug 2016
Results first posted
Aug 7, 2017
Last update
Aug 7, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02554877
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 18, 2015
Start date
Oct 2015
Primary completion
Aug 2016
Completion
Aug 2016
Results posted
Aug 7, 2017
Last update
Aug 7, 2017

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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