Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus (NCT NCT04552470)

Last Updated: 2022-03-11

Results Overview

An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. Treatment emergent AEs were events between first dose of study drug and approximately 4 weeks after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

37 participants

Primary outcome timeframe

Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)

Results posted on

2022-03-11

Participant Flow

65 participants signed the inform consent form (ICF). 28 participants were screen failures who did not meet criteria and were not enrolled. 37 participants enrolled into the study and assigned to a study treatment.

Participant milestones

Participant milestones
Measure	Placebo Participants with type 2 diabetes mellitus (T2DM) were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 40 mg Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 80 mg Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 120 mg Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Overall Study STARTED	9	10	9	9
Overall Study COMPLETED	9	10	9	9
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=9 Participants Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 40 mg n=10 Participants Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 80 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 120 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.	Total n=37 Participants Total of all reporting groups
Age, Continuous	58.6 Years STANDARD_DEVIATION 8.75 • n=93 Participants	55.9 Years STANDARD_DEVIATION 10.04 • n=4 Participants	58.0 Years STANDARD_DEVIATION 6.69 • n=27 Participants	50.7 Years STANDARD_DEVIATION 7.50 • n=483 Participants	55.8 Years STANDARD_DEVIATION 8.62 • n=36 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	5 Participants n=36 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	8 Participants n=4 Participants	8 Participants n=27 Participants	8 Participants n=483 Participants	32 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=93 Participants	10 Participants n=4 Participants	9 Participants n=27 Participants	9 Participants n=483 Participants	37 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	9 Participants n=93 Participants	10 Participants n=4 Participants	9 Participants n=27 Participants	9 Participants n=483 Participants	37 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants

PRIMARY outcome

Timeframe: Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)

Population: Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 40 mg n=10 Participants Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 80 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 120 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with AEs	3 Participants	7 Participants	9 Participants	9 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with SAEs	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks)

Population: Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.

Leukocytes (10\^9/liter \[L\]) bilirubin (micromol/L), glucose (millimoles \[mmol\]/L), triacylglycerol lipase (microkatals \[microkat\]/L): greater than (\>) 1.5\*upper limit normal (ULN); activated partial thromboplastin time (s): 1.1\*ULN; HDL cholesterol (mmol/L), thyroid stimulating hormone (TSH) (milliunits \[mU\]/L): less than (\<) 0.8\*lower limit normal (LLN); LDL cholesterol (mmol/L), urate (mmol/L): \>1.2\*ULN; triglycerides: \>1.3\*ULN; aspartate aminotransferase (microkat/L), alanine aminotransferase (microkat/L), gamma glutamyl transferase (microkat/L): \>3.0\*ULN; cholesterol (mmol/L): \>1.3\*ULN; urine glucose, ketones urine protein, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase: greater than or equal to (\>=) 1; granular casts, hyaline casts: \>1.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 40 mg n=10 Participants Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 80 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 120 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Number of Participants With Clinical Laboratory Abnormalities	9 Participants	10 Participants	8 Participants	9 Participants

PRIMARY outcome

Timeframe: Baseline (1 Day before dosing) up to last dose (maximum up to Week 8)

Population: Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.

Supine systolic blood pressure (SBP) measured in millimeter of mercury (mmHg) had following categories: minimum of absolute SBP \<90 mmHg, maximum of SBP \>=30 mmHg decrease from baseline and maximum of SBP \>=30 mmHg increase from baseline. Supine diastolic blood pressure (DBP) measured in mmHg had following categories: minimum of absolute DBP \<50 mmHg, maximum of DBP \>20 mmHg decrease from baseline and maximum of DBP \>=20 mmHg increase from baseline. Supine pulse rate measured in beats per minute (BPM) had following categories: minimum of absolute supine pulse rate \<40 BPM and maximum of absolute supine pulse rate \>120 BPM. Baseline was defined as the time-matched value from the average of the triplicate recordings on Day -1.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 40 mg n=10 Participants Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 80 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 120 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline Minimum of absolute SBP <90 mmHg	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline Maximum of SBP >=30 mmHg decrease	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline Minimum of absolute DBP <50 mmHg	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline Maximum of DBP >=20 mmHg decrease	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline Minimum of absolute pulse rate <40 BPM	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline Maximum of absolute pulse rate >120 BPM	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline Maximum of SBP >=30 mmHg increase	3 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Absolute Vital Signs (SBP, DBP and Pulse Rate) Values; Increased and Decreased Vital Signs (SBP, DBP) Values From Time-Matched Baseline Maximum of DBP >=20 mmHg increase	1 Participants	2 Participants	3 Participants	3 Participants

PRIMARY outcome

Timeframe: Baseline (1 Day before dosing) up to last dose (maximum up to Week 8)

Population: Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.

PR interval had following categories: maximum absolute PR interval \>=300 milliseconds (msec); when baseline PR interval \>200 msec and maximum increase from baseline in PR interval \>=25 percent; when baseline PR interval less than or equal to (\<=) 200 msec and maximum increase from baseline in PR interval \>=50 percent. QRS interval had following categories: maximum absolute QRS interval \>=140 msec; maximum increase from baseline in QRS interval \>=50 percent. QTC interval with Frederica's correction (QTCF) had following categories: absolute QTCF interval \>450 msec to \<=480 msec; absolute QTCF interval \>480 msec to \<=500 msec; absolute QTCF interval \>500 msec; QTCF interval increase from baseline \>=30 msec to \<=60 msec; QTCF interval increase from baseline \>60 msec.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 40 mg n=10 Participants Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 80 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 120 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline Baseline PR >200 msec and maximum increase in PR >=25%	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline Baseline PR <=200 msec and maximum increase in PR >=50%	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline Maximum absolute QRS >=140 msec	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline Absolute QTCF interval >480 msec to <=500 msec	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline Maximum absolute PR >=300 msec	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline Maximum increase in QRS >=50%	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline Absolute QTCF interval >450 msec to <=480 msec	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline Absolute QTCF >500 msec	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline QTCF increase >=30 msec to <=60 msec	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline QTCF increase >60 msec	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1 and 56

Population: Pharmacokinetic (PK) parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports AUC24 of PF-06882961, hence there is no data collected and analyzed for reporting arm "Placebo". Here "Number Analyzed" signifies participants evaluable at specified time points.

AUC24= Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours (0-24).

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 40 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 80 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 120 mg Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Area Under the Plasma Concentration-time Profile From Zero to Time 24 Hours (AUC24) of PF-06882961 Day 1	414.4 Nanogram*hour per milliliter Geometric Coefficient of Variation 58	500.3 Nanogram*hour per milliliter Geometric Coefficient of Variation 58	484.5 Nanogram*hour per milliliter Geometric Coefficient of Variation 73	—
Area Under the Plasma Concentration-time Profile From Zero to Time 24 Hours (AUC24) of PF-06882961 Day 56	2424 Nanogram*hour per milliliter Geometric Coefficient of Variation 45	4691 Nanogram*hour per milliliter Geometric Coefficient of Variation 75	6953 Nanogram*hour per milliliter Geometric Coefficient of Variation 148	—

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1; Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56

Population: PK parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports Cmax of PF-06882961, hence there is no data collected and analyzed for reporting arm "Placebo". Here "Number Analyzed" signifies participants evaluable at specified time points.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 40 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 80 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 120 mg Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Maximum Plasma Concentration (Cmax) Observed of PF-06882961 Day 1	32.83 Nanogram per milliliter Geometric Coefficient of Variation 55	45.89 Nanogram per milliliter Geometric Coefficient of Variation 52	39.35 Nanogram per milliliter Geometric Coefficient of Variation 80	—
Maximum Plasma Concentration (Cmax) Observed of PF-06882961 Day 56	206.1 Nanogram per milliliter Geometric Coefficient of Variation 54	352.2 Nanogram per milliliter Geometric Coefficient of Variation 75	551.7 Nanogram per milliliter Geometric Coefficient of Variation 153	—

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1; Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56

Population: PK parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports Tmax of PF-06882961, hence there is no data collected and analyzed for reporting arm "Placebo". Here "Number Analyzed" signifies participants evaluable at specified time points.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 40 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 80 mg n=9 Participants Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 120 mg Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06882961 Day 1	12.0 Hours Interval 2.0 to 23.8	12.0 Hours Interval 1.0 to 12.0	12.0 Hours Interval 1.0 to 14.0	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06882961 Day 56	12.0 Hours Interval 6.0 to 13.8	12.9 Hours Interval 2.0 to 36.0	12.0 Hours Interval 0.0 to 13.8	—

SECONDARY outcome

Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 8, 10, 12, 14, 24, 36 and 48 hours on Day 56

Population: PK parameter analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest calculated. This outcome measure reports t1/2 of PF-06882961, hence there is no data collected and analyzed for reporting arm "Placebo".

t1/2 was calculated as loge (2) per kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 40 mg n=3 Participants Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 80 mg n=7 Participants Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 120 mg Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Terminal Phase Half-Life (t1/2) of PF-06882961	6.373 Hours Standard Deviation 1.7404	5.543 Hours Standard Deviation 0.30827	5.300 Hours Standard Deviation 0.80594	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

PF-06882961 40 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

PF-06882961 80 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

PF-06882961 120 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

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 the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER

Measure	Placebo n=9 participants at risk Participants with T2DM were randomized to receive placebo matched to PF-06882961 tablet twice daily, for 8 weeks. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 40 mg n=10 participants at risk Participants with T2DM were randomized to receive PF-06882961 10 milligram (mg) tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2. After this titration, participants received 40 mg tablet twice daily from Week 3 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 80 mg n=9 participants at risk Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4. After this titration, participants received 80 mg tablet twice daily from Week 5 to 8. Post treatment participants were followed approximately for 4 weeks.	PF-06882961 120 mg n=9 participants at risk Participants with T2DM were randomized to receive PF-06882961 10 mg tablet twice daily on Week 1, 20 mg tablet twice daily on Week 2, 40 mg tablet twice daily on Week 3, 60 mg tablet twice daily on Week 4, 80 mg tablet twice daily on Week 5, 100 mg tablet twice daily on Week 6. After this titration, participants received 120 mg tablet twice daily from Week 7 to 8. Post treatment participants were followed approximately for 4 weeks.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	40.0% 4/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	44.4% 4/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	55.6% 5/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	11.1% 1/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Gastrointestinal disorders Dental caries	11.1% 1/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	11.1% 1/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Gastrointestinal disorders Diarrhoea	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	10.0% 1/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	22.2% 2/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	11.1% 1/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Gastrointestinal disorders Nausea	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	60.0% 6/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	88.9% 8/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	44.4% 4/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Gastrointestinal disorders Stomatitis	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	11.1% 1/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	50.0% 5/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	66.7% 6/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	55.6% 5/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Infections and infestations Gastroenteritis	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	10.0% 1/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Infections and infestations Hordeolum	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	10.0% 1/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Infections and infestations Influenza	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	11.1% 1/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Investigations Alanine aminotransferase increased	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	10.0% 1/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Investigations Aspartate aminotransferase increased	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	10.0% 1/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Investigations Lipase increased	11.1% 1/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	11.1% 1/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	11.1% 1/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	10.0% 1/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Nervous system disorders Headache	11.1% 1/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	20.0% 2/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	11.1% 1/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Nervous system disorders Presyncope	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	11.1% 1/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/10 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	11.1% 1/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/9 • Day 1 of dosing up to approximately 4 weeks after last dose (up to maximum of approximately 12 weeks) Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.