Trial Outcomes & Findings for A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus (NCT NCT03969719)
NCT ID: NCT03969719
Last Updated: 2022-05-11
Results Overview
Whole liver fat was measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF).
COMPLETED
PHASE2
164 participants
Baseline, Week 16.
2022-05-11
Participant Flow
Participant milestones
| Measure |
Placebo
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
54
|
55
|
55
|
|
Overall Study
COMPLETED
|
50
|
46
|
50
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
5
|
Reasons for withdrawal
| Measure |
Placebo
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Overall Study
Other reasons not specified
|
1
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=54 Participants
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=55 Participants
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=55 Participants
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<18 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
18-64 Years
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Age, Customized
65-84 Years
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Age, Customized
>=85 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
38 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16.Population: The full analysis set (FAS) included all participants randomly assigned to treatment and who took at least 1 dose of treatment. Participants who were in the FAS and had the liver fat value at Week 16 were analyzed.
Whole liver fat was measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF).
Outcome measures
| Measure |
Placebo
n=47 Participants
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=41 Participants
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=49 Participants
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Whole Liver Fat at Week 16
|
-3.21 Percent change
Standard Deviation 26.997
|
-16.12 Percent change
Standard Deviation 22.773
|
-4.36 Percent change
Standard Deviation 45.825
|
PRIMARY outcome
Timeframe: Baseline, Week 16.Population: The FAS included all participants randomly assigned to treatment and who took at least 1 dose of treatment. Participants who were in the FAS and had the HbA1c value at Week 16 were analyzed.
A sufficient amount of blood was collected for the analysis of plasma HbA1c.
Outcome measures
| Measure |
Placebo
n=50 Participants
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=46 Participants
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=49 Participants
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16
|
-0.14 Percent of HbA1c
Standard Deviation 0.947
|
-0.24 Percent of HbA1c
Standard Deviation 0.779
|
-0.32 Percent of HbA1c
Standard Deviation 0.764
|
SECONDARY outcome
Timeframe: Up to 21 weeks.Population: The safety analysis set included all participants randomly assigned to treatment and who took at least 1 dose of treatment.
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or that was considered to be an important medical event. An AE was considered TEAE if the event occurred during the on-treatment period. The causality of AEs were assessed by the investigator using clinical judgement. A severe AE was an event that prevents normal everyday activities.
Outcome measures
| Measure |
Placebo
n=54 Participants
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=55 Participants
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=55 Participants
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with All-causality TEAEs
|
22 Participants
|
25 Participants
|
18 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with Treatment-related TEAEs
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with All-causality Serious TEAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with All-causality Severe TEAEs
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants discontinued from study due to All-causality TEAEs
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants discontinued study drug due to All-causality TEAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with dose reductions or temporary discontinuation due to All-causality TEAEs
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 21 weeks.Population: The safety analysis set included all participants randomly assigned to treatment and who took at least 1 dose of treatment.
Hypoglycemic AEs were routinely monitored during participation in the study. Hypoglycemic AE was defined as 1 of the following: 1. Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemic AE but a plasma glucose value of \<70 milligram per deciliter (mg/dL) using glucometer; 2. Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemic AEs were accompanied with a glucose value of \<70 mg/dL using glucometer and the clinical picture included prompt resolution with food intake, subcutaneous glucagon or intravenous (IV) glucose; 3. Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemic AEs were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose concentration of \<70 mg/dL, and the clinical picture included prompt resolution with food intake, subcutaneous glucagon, or IV glucose.
Outcome measures
| Measure |
Placebo
n=54 Participants
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=55 Participants
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=55 Participants
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Number of Participants With Hypoglycemia TEAEs
Asymptomatic hypoglycemia
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hypoglycemia TEAEs
Severe hypoglycemia
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hypoglycemia TEAEs
Documented symptomatic hypoglycemia
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hypoglycemia TEAEs
Probable symptomatic hypoglycemia
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 21 weeks.Population: The safety analysis set included all participants randomly assigned to treatment and who took at least 1 dose of treatment. Participants with evaluable laboratory values were analyzed.
Clinical laboratory tests included hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean cell hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein); urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy). The abnormality criteria were standard sponsor reporting criteria.
Outcome measures
| Measure |
Placebo
n=53 Participants
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=54 Participants
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=55 Participants
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Cumulative Number of Participants With Clinical Laboratory Abnormalities
|
52 Participants
|
52 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Up to 21 weeks.Population: The safety analysis set included all participants randomly assigned to treatment and who took at least 1 dose of treatment. Participants with evaluable vital signs data were analyzed.
Vital signs data meeting the following criteria were reported: sitting diastolic blood pressure (DBP) \<50 mmHg or \>= 20 mmHg increase or \>= 20 mmHg decrease, sitting systolic blood pressure (SBP) blood pressure \<90 mmHg or \>=30 mmHg increase or \>=30 mmHg decrease.
Outcome measures
| Measure |
Placebo
n=53 Participants
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=54 Participants
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=55 Participants
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria
DBP value <50 mmHg
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria
DBP change >= 20 mmHg increase
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria
DBP change >=20 mmHg decrease
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria
SBP value <90 mmHg
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria
SBP change >= 30 mmHg increase
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria
SBP change >=30 mmHg decrease
|
5 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 21 weeks.Population: The safety analysis set included all participants randomly assigned to treatment and who took at least 1 dose of treatment. Participants with evaluable ECG data were analyzed.
ECG data meeting the following criteria were reported: PR interval value \>=300 msec, QRS interval percent change \>= 50%, QTcF interval value \>450 msec and \<=480 msec, or change \>30 msec and \<=60 msec, or change \>60 msec.
Outcome measures
| Measure |
Placebo
n=53 Participants
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=54 Participants
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=55 Participants
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria
PR interval value >= 300 msec
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria
QRS interval percent change >= 50%
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria
QTcF interval value >450 msec and <= 480 msec
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria
QTcF interval change >30 msec and <=60 msec
|
1 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria
QTcF interval change >60 msec
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.Population: The FAS included all participants randomly assigned to treatment and who took at least 1 dose of treatment. Participants who were in the FAS and had the hs-CRP values at each timepoint were analyzed.
Blood samples were collected to ensure sufficient serum for the analysis of hs-CRP.
Outcome measures
| Measure |
Placebo
n=54 Participants
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=55 Participants
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=55 Participants
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over 16 Weeks
Week 2
|
40.26 Percent change
Standard Deviation 129.051
|
19.11 Percent change
Standard Deviation 85.912
|
17.50 Percent change
Standard Deviation 159.122
|
|
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over 16 Weeks
Week 4
|
50.64 Percent change
Standard Deviation 195.742
|
38.46 Percent change
Standard Deviation 185.938
|
-18.25 Percent change
Standard Deviation 41.961
|
|
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over 16 Weeks
Week 8
|
93.82 Percent change
Standard Deviation 446.720
|
13.09 Percent change
Standard Deviation 62.564
|
-17.23 Percent change
Standard Deviation 51.612
|
|
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over 16 Weeks
Week 12
|
31.29 Percent change
Standard Deviation 86.516
|
14.99 Percent change
Standard Deviation 62.415
|
-9.68 Percent change
Standard Deviation 90.926
|
|
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over 16 Weeks
Week 16
|
102.16 Percent change
Standard Deviation 449.453
|
9.37 Percent change
Standard Deviation 57.144
|
7.11 Percent change
Standard Deviation 109.031
|
SECONDARY outcome
Timeframe: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.Population: The FAS included all participants randomly assigned to treatment and who took at least 1 dose of treatment. Participants who were in the FAS and had the insulin values at each timepoint were analyzed.
A sufficient amount of blood was collected for the analysis of plasma insulin. The unit of insulin is milli-international units per liter (mIU/L).
Outcome measures
| Measure |
Placebo
n=54 Participants
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=55 Participants
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=55 Participants
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Insulin Over 16 Weeks
Week 2
|
1.79 mIU/L
Standard Deviation 9.275
|
2.94 mIU/L
Standard Deviation 14.375
|
1.53 mIU/L
Standard Deviation 16.837
|
|
Change From Baseline in Fasting Insulin Over 16 Weeks
Week 4
|
2.22 mIU/L
Standard Deviation 12.723
|
1.65 mIU/L
Standard Deviation 20.118
|
-2.47 mIU/L
Standard Deviation 10.672
|
|
Change From Baseline in Fasting Insulin Over 16 Weeks
Week 8
|
2.56 mIU/L
Standard Deviation 12.617
|
13.01 mIU/L
Standard Deviation 63.009
|
-0.45 mIU/L
Standard Deviation 16.336
|
|
Change From Baseline in Fasting Insulin Over 16 Weeks
Week 12
|
3.00 mIU/L
Standard Deviation 13.202
|
9.70 mIU/L
Standard Deviation 65.593
|
3.52 mIU/L
Standard Deviation 19.148
|
|
Change From Baseline in Fasting Insulin Over 16 Weeks
Week 16
|
1.99 mIU/L
Standard Deviation 8.862
|
17.94 mIU/L
Standard Deviation 101.553
|
4.84 mIU/L
Standard Deviation 39.099
|
SECONDARY outcome
Timeframe: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.Population: The FAS included all participants randomly assigned to treatment and who took at least 1 dose of treatment. Participants who were in the FAS and had the glucose values at each timepoint were analyzed.
A sufficient amount of blood was collected for the analysis of plasma glucose.
Outcome measures
| Measure |
Placebo
n=54 Participants
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=55 Participants
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=55 Participants
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Glucose Over 16 Weeks
Week 8
|
6.55 milligram per deciliter (mg/dL)
Standard Deviation 36.609
|
-2.40 milligram per deciliter (mg/dL)
Standard Deviation 51.102
|
-2.87 milligram per deciliter (mg/dL)
Standard Deviation 55.355
|
|
Change From Baseline in Fasting Glucose Over 16 Weeks
Week 2
|
7.27 milligram per deciliter (mg/dL)
Standard Deviation 25.844
|
0.88 milligram per deciliter (mg/dL)
Standard Deviation 32.783
|
-6.35 milligram per deciliter (mg/dL)
Standard Deviation 42.660
|
|
Change From Baseline in Fasting Glucose Over 16 Weeks
Week 4
|
5.42 milligram per deciliter (mg/dL)
Standard Deviation 33.198
|
-7.41 milligram per deciliter (mg/dL)
Standard Deviation 39.870
|
-4.47 milligram per deciliter (mg/dL)
Standard Deviation 41.630
|
|
Change From Baseline in Fasting Glucose Over 16 Weeks
Week 12
|
8.94 milligram per deciliter (mg/dL)
Standard Deviation 40.207
|
-6.45 milligram per deciliter (mg/dL)
Standard Deviation 47.793
|
-12.02 milligram per deciliter (mg/dL)
Standard Deviation 45.748
|
|
Change From Baseline in Fasting Glucose Over 16 Weeks
Week 16
|
3.42 milligram per deciliter (mg/dL)
Standard Deviation 40.723
|
-4.17 milligram per deciliter (mg/dL)
Standard Deviation 43.868
|
-10.69 milligram per deciliter (mg/dL)
Standard Deviation 56.683
|
SECONDARY outcome
Timeframe: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.Population: The FAS included all participants randomly assigned to treatment and who took at least 1 dose of treatment. Participants who were in the FAS and had the HOMA-IR values at each timepoint were analyzed.
HOMA-IR values were derived from fasting plasma insulin and glucose values. Greater reduction from baseline in HOMA-IR scale values shows greater effects on glycemic metabolism.
Outcome measures
| Measure |
Placebo
n=54 Participants
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=55 Participants
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=55 Participants
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Over 16 Weeks
Week 2
|
1.09 HOMA-IR scale
Standard Deviation 4.573
|
2.17 HOMA-IR scale
Standard Deviation 12.473
|
0.36 HOMA-IR scale
Standard Deviation 6.318
|
|
Change From Baseline in Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Over 16 Weeks
Week 4
|
1.28 HOMA-IR scale
Standard Deviation 5.455
|
0.02 HOMA-IR scale
Standard Deviation 5.452
|
-1.04 HOMA-IR scale
Standard Deviation 4.407
|
|
Change From Baseline in Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Over 16 Weeks
Week 8
|
1.32 HOMA-IR scale
Standard Deviation 5.161
|
2.94 HOMA-IR scale
Standard Deviation 11.062
|
-0.49 HOMA-IR scale
Standard Deviation 6.683
|
|
Change From Baseline in Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Over 16 Weeks
Week 12
|
1.84 HOMA-IR scale
Standard Deviation 6.045
|
8.92 HOMA-IR scale
Standard Deviation 63.895
|
0.98 HOMA-IR scale
Standard Deviation 7.778
|
|
Change From Baseline in Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Over 16 Weeks
Week 16
|
0.82 HOMA-IR scale
Standard Deviation 3.768
|
8.26 HOMA-IR scale
Standard Deviation 45.267
|
3.45 HOMA-IR scale
Standard Deviation 29.220
|
SECONDARY outcome
Timeframe: From Baseline to Week 2, Week, 4, Week 8, Week 12 and Week 16.Population: The FAS included all participants randomly assigned to treatment and who took at least 1 dose of treatment. Participants who were in the FAS and had the ALT values at each timepoint were analyzed.
ALT was assessed as one of the clinical laboratory chemistry tests.
Outcome measures
| Measure |
Placebo
n=54 Participants
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=55 Participants
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=55 Participants
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Alanine Aminotransferase (ALT) Over 16 Weeks
Week 8
|
6.7 Percent change
Standard Deviation 63.32
|
-6.3 Percent change
Standard Deviation 23.72
|
-10.5 Percent change
Standard Deviation 29.16
|
|
Percent Change From Baseline in Alanine Aminotransferase (ALT) Over 16 Weeks
Week 12
|
-3.4 Percent change
Standard Deviation 32.14
|
-7.9 Percent change
Standard Deviation 29.01
|
-10.7 Percent change
Standard Deviation 23.96
|
|
Percent Change From Baseline in Alanine Aminotransferase (ALT) Over 16 Weeks
Week 16
|
20.4 Percent change
Standard Deviation 78.74
|
-7.8 Percent change
Standard Deviation 29.36
|
-9.8 Percent change
Standard Deviation 25.89
|
|
Percent Change From Baseline in Alanine Aminotransferase (ALT) Over 16 Weeks
Week 2
|
2.4 Percent change
Standard Deviation 34.69
|
-8.8 Percent change
Standard Deviation 20.43
|
-6.0 Percent change
Standard Deviation 22.36
|
|
Percent Change From Baseline in Alanine Aminotransferase (ALT) Over 16 Weeks
Week 4
|
2.3 Percent change
Standard Deviation 29.13
|
-4.1 Percent change
Standard Deviation 29.51
|
-5.4 Percent change
Standard Deviation 27.86
|
SECONDARY outcome
Timeframe: From Baseline to Week 2, Week, 4, Week 8, and Week 12.Population: The FAS included all participants randomly assigned to treatment and who took at least 1 dose of treatment. Participants who were in the FAS and had the HbA1c values at each timepoint were analyzed.
A sufficient amount of blood was collected for the analysis of plasma HbA1c.
Outcome measures
| Measure |
Placebo
n=54 Participants
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=55 Participants
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=55 Participants
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Change From Baseline in HbA1c at All Timepoints Other Than Week 16
Week 2
|
-0.14 Percent of HbA1c
Standard Deviation 0.626
|
-0.11 Percent of HbA1c
Standard Deviation 0.592
|
-0.07 Percent of HbA1c
Standard Deviation 0.256
|
|
Change From Baseline in HbA1c at All Timepoints Other Than Week 16
Week 4
|
-0.09 Percent of HbA1c
Standard Deviation 0.428
|
-0.17 Percent of HbA1c
Standard Deviation 0.633
|
-0.21 Percent of HbA1c
Standard Deviation 0.357
|
|
Change From Baseline in HbA1c at All Timepoints Other Than Week 16
Week 8
|
-0.11 Percent of HbA1c
Standard Deviation 0.588
|
-0.22 Percent of HbA1c
Standard Deviation 0.698
|
-0.27 Percent of HbA1c
Standard Deviation 0.588
|
|
Change From Baseline in HbA1c at All Timepoints Other Than Week 16
Week 12
|
-0.12 Percent of HbA1c
Standard Deviation 0.816
|
-0.15 Percent of HbA1c
Standard Deviation 0.748
|
-0.28 Percent of HbA1c
Standard Deviation 0.681
|
Adverse Events
Placebo
PF-06835919 150 mg
PF-06835919 300 mg
Serious adverse events
| Measure |
Placebo
n=54 participants at risk
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=55 participants at risk
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=55 participants at risk
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/54 • Up to 21 weeks.
|
1.8%
1/55 • Up to 21 weeks.
|
0.00%
0/55 • Up to 21 weeks.
|
Other adverse events
| Measure |
Placebo
n=54 participants at risk
All participants received placebo matched to PF-06835919 once daily (QD) for 16 Weeks.
|
PF-06835919 150 mg
n=55 participants at risk
All participants received PF-06835919 150 mg QD for 16 Weeks.
|
PF-06835919 300 mg
n=55 participants at risk
All participants received PF-06835919 300 mg QD for 16 Weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
2/54 • Up to 21 weeks.
|
5.5%
3/55 • Up to 21 weeks.
|
0.00%
0/55 • Up to 21 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/54 • Up to 21 weeks.
|
7.3%
4/55 • Up to 21 weeks.
|
0.00%
0/55 • Up to 21 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.6%
3/54 • Up to 21 weeks.
|
1.8%
1/55 • Up to 21 weeks.
|
0.00%
0/55 • Up to 21 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/54 • Up to 21 weeks.
|
5.5%
3/55 • Up to 21 weeks.
|
0.00%
0/55 • Up to 21 weeks.
|
|
Nervous system disorders
Headache
|
5.6%
3/54 • Up to 21 weeks.
|
1.8%
1/55 • Up to 21 weeks.
|
1.8%
1/55 • Up to 21 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclosure previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER