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CompletedNCT03538743Updated Jul 1, 2020Results posted

4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes

A Phase 1 interventional study of Placebo and PF-06882961 in Type 2 Diabetes Mellitus, sponsored by Pfizer. Completed at 4 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-01.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants will receive an investigational product or placebo for 28 days.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Type 2 diabetes mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 98 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

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

Inclusion criteria

  • Type 2 diabetes treated with a stable dose of metformin at least 500 mg
  • HbA1c value between 7.0 and 10.5%

Exclusion criteria

Exclusion Criteria:

  • Type 1 diabetes or secondary forms of diabetes
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
98 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    PF-06882961 30 mg

    Drug: PF-06882961

  • Experimental
    PF-06882961 100 mg

    Drug: PF-06882961

  • Experimental
    PF-06882961 300 mg

    Drug: PF-06882961

  • Experimental
    PF-06882961 600 mg

    Drug: PF-06882961

  • Experimental
    PF-06882961 dose TBD Cohort 5

    Drug: PF-06882961

  • Experimental
    PF-06882961 dose TBD Cohort 6

    Drug: PF-06882961

  • Experimental
    PF-06882961 dose TBD Cohort 7

    Drug: PF-06882961

  • Experimental
    PF-06882961 dose TBD Cohort 8

    Drug: PF-06882961

Interventions

  • DrugPlacebo

    Tablet, 0 mg, twice daily, 28 days

  • DrugPF-06882961

    Tablet, 15 mg twice daily, 28 days

  • DrugPF-06882961

    Tablet, 50 mg twice daily, 28 days

  • DrugPF-06882961

    Tablet, 150 mg twice daily, 28 days

  • DrugPF-06882961

    Tablet, 300 mg twice daily, 28 days

  • DrugPF-06882961

    Tablet, dose TBD, twice daily, Cohort 5, 28 days

  • DrugPF-06882961

    Tablet, dose TBD, twice daily, Cohort 6, 28 days

  • DrugPF-06882961

    Tablet, dose TBD, twice daily, Cohort 7, 28 days

  • DrugPF-06882961

    Tablet, dose TBD, twice daily, Cohort 8, 28 days

06

What researchers measure

Primary outcomes

  1. Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)

    Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.

    Time frame: From baseline to up to 35 days after last dose for a total of approximately 63 days

  2. Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality

    Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time \[PT\], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin).

    Time frame: From baseline to up to 14 days after last dose for a total of approximately 42 days

  3. Number of Participants With Abnormal Vital Signs

    Vital signs categorical summarization criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (\>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP \>= 20 mmHg.

    Time frame: From baseline to up to 14 days after last dose for a total of approximately 42 days

  4. Number of Participants With Abnormal Electrocardiogram (ECG) Interval

    ECG categorical summarization criteria: 1. PR interval (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): a) greater than or equal to (\>=) 300 millisecond (msec), b) \>=25% increase when baseline is \> 200 msec or \>=50% increase when baseline is less than or equal to (\<=) 200 msec. 2. QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) \>=140 msec, b) \>=50% increase from baseline. 3. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and \<=480 msec, b) \>480 msec and \<=500 msec, c) \>500 msec, d) \>30 msec and \<=60 msec increase from baseline, e) \>60 msec increase from baseline

    Time frame: From baseline to up to 14 days after last dose for a total of approximately 42 days

Secondary outcomes

  1. AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28

    Area under the concentration-time profile from time zero to time 24 hours (AUC24) was calculated as AUCtau1 +AUCtau2, where AUCtau was area under the plasma concentration-time profile from time zero to time tau (tau1 = 0 to 10 hours and tau2=10 to 24 hours). AUCtau was determined using linear/log trapezoidal method.

    Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28

  2. Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28

    For BID dosing, parameters were calculated for both dosing intervals (0-10 hr = interval 1 and 10-24 hr = interval 2) and were displayed as Cmax1, Cmax2. Cmax1: maximum plasma concentration during the dosing interval τ1 =0 to 10 hours. Cmax2: maximum plasma concentration during the dosing interval τ2=10 to 24 hours.

    Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28

  3. Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28

    Time for Cmax, Cmax1 and Cmax2 (Tmax, Tmax1 and Tmax2) of PF-06293620 was observed directly from data as time of first occurrence.

    Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28

  4. Terminal Half-life (t½) of PF-06882961 on Day 28

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28

  5. Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28

    Ae was the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval was 24 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram \[g\]/1.020), where 1.020 g/mL was the approximate specific gravity of urine.

    Time frame: 0 to 24 hours post-dose on Day 28

  6. Ae24 (%) of PF-06882961 on Day 28

    Percent of dose recovered in urine as unchanged drug. Ae24% = 100\* Ae24/Dose

    Time frame: 0 to 24 hours post-dose on Day 28

  7. Renal Clearance (CLr) of PF-06882961 on Day 28

    CLr was calculated as Ae divided by AUCtau, where dosing interval is 24 hours.

    Time frame: 0 to 24 hours post-dose on Day 28

07

Results

Posted Jul 1, 2020

Participant flow

Participant flow — Overall Study
MilestonePlaceboPF-06882961 10mg BIDPF-06882961 15mg BIDPF-06882961 50mg BIDPF-06882961 70mg BIDPF-06882961 120mg BIDPF-06882961 120mg BID Slow Titration (ST)PF-06882961 120mg QDPF-06882961 200mg QD Controlled Release (CR)
Started259910999810
Received treatment259910999810
Completed2598899987
Not completed001200003
Withdrew: Adverse event001100000
Withdrew: Non-treatment-related reasons000000003
Withdrew: Withdrawal by subject000100000

Outcome measures

PrimaryNumber of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)

Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.

Time frame:
From baseline to up to 35 days after last dose for a total of approximately 63 days
Reported as:
Count of participants · Participants
Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)
ParticipantsPlaceboPF-06882961 10mg BIDPF-06882961 15mg BIDPF-06882961 50mg BIDPF-06882961 70mg BIDPF-06882961 120mg BIDPF-06882961 120mg BID STPF-06882961 120mg QDPF-06882961 200mg QD CR
All-causality AE17681088989
All-causality SAE000000100
Treatment-related AE14441078989
Treatment-related SAE000000000
PrimaryNumber of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality

Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time \[PT\], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin).

Time frame:
From baseline to up to 14 days after last dose for a total of approximately 42 days
Reported as:
Count of participants · Participants
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
ParticipantsPlaceboPF-06882961 10mg BIDPF-06882961 15mg BIDPF-06882961 50mg BIDPF-06882961 70mg BIDPF-06882961 120mg BIDPF-06882961 120mg BID STPF-06882961 120mg QDPF-06882961 200mg QD CR
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality247810889710
PrimaryNumber of Participants With Abnormal Vital Signs

Vital signs categorical summarization criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (\>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP \>= 20 mmHg.

Time frame:
From baseline to up to 14 days after last dose for a total of approximately 42 days
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Vital Signs
ParticipantsPlaceboPF-06882961 10mg BIDPF-06882961 15mg BIDPF-06882961 50mg BIDPF-06882961 70mg BIDPF-06882961 120mg BIDPF-06882961 120mg BID STPF-06882961 120mg QDPF-06882961 200mg QD CR
Supine SBP <90 mmHg332130301
Supine SBP increase >=30 mmHg400231221
Supine SBP decrease >=30 mmHg925353354
Supine DBP <50 mmHg112110200
Supine DBP increase >=20 mmHg111041221
Supine DBP decrease >=20 mmHg621213423
Supine pulse rate <40 bpm000000000
Supine pulse rate >120 bpm000000000
PrimaryNumber of Participants With Abnormal Electrocardiogram (ECG) Interval

ECG categorical summarization criteria: 1. PR interval (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): a) greater than or equal to (\>=) 300 millisecond (msec), b) \>=25% increase when baseline is \> 200 msec or \>=50% increase when baseline is less than or equal to (\<=) 200 msec. 2. QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) \>=140 msec, b) \>=50% increase from baseline. 3. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and \<=480 msec, b) \>480 msec and \<=500 msec, c) \>500 msec, d) \>30 msec and \<=60 msec increase from baseline, e) \>60 msec increase from baseline

Time frame:
From baseline to up to 14 days after last dose for a total of approximately 42 days
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Interval
ParticipantsPlaceboPF-06882961 10mg BIDPF-06882961 15mg BIDPF-06882961 50mg BIDPF-06882961 70mg BIDPF-06882961 120mg BIDPF-06882961 120mg BID STPF-06882961 120mg QDPF-06882961 200mg QD CR
PR interval ≥300 msec000000000
%Change in PR interval ≥25/50%000000000
QRS duration ≥140 msec000000000
%Change in QRS duration ≥50%000000000
QTcF interval >450 and ≤480 msec201000000
QTcF interval >480 and ≤500 msec000000000
QTcF interval >500 msec000000000
Change in QTcF interval >30 and ≤60 msec010001000
Change in QTcF interval >60 msec000000000
SecondaryAUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28

Area under the concentration-time profile from time zero to time 24 hours (AUC24) was calculated as AUCtau1 +AUCtau2, where AUCtau was area under the plasma concentration-time profile from time zero to time tau (tau1 = 0 to 10 hours and tau2=10 to 24 hours). AUCtau was determined using linear/log trapezoidal method.

Time frame:
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
Reported as:
Geometric mean · nanogram.hours/milliliter (ng.h/mL)
AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
nanogram.hours/milliliter (ng.h/mL)PF-06882961 15mg BID (Cohort 1)PF-06882961 50mg BID (Cohort 2)PF-06882961 70mg BID (Cohort 3)PF-06882961 120mg BID (Cohort 4)PF-06882961 10mg BID (Cohort 5)PF-06882961 120mg BID ST (Cohort 6)PF-06882961 200mg QD CR (Cohort 7)PF-06882961 120mg QD (Cohort 8)
AUC24 on Day 1707.5 ± 431502 ± 29645.8 ± 52666.1 ± 54178.7 ± 72324.0 ± 41393.9 ± 80184.6 ± 49
AUCtau1 on Day 1288.1 ± 37741.4 ± 35279.7 ± 49260.3 ± 4574.50 ± 66147.7 ± 43NA ± NANA ± NA
AUCtau2 on Day 1414.8 ± 50678.5 ± 79364.9 ± 56401.9 ± 62103.7 ± 76176.4 ± 42NA ± NANA ± NA
AUC24 on Day 14 or 21853.8 ± 452092 ± 912988 ± 598149 ± 84201.6 ± 632660 ± 761291 ± 681204 ± 43
AUCtau1 on Day 14 or 21348.6 ± 48880.3 ± 781462 ± 703772 ± 8585.57 ± 59957.3 ± 66NA ± NANA ± NA
AUCtau2 on Day 14 or 21500.1 ± 461175 ± 1101517 ± 534361 ± 89115.4 ± 681693 ± 83NA ± NANA ± NA
AUC24 on Day 28876.7 ± 411653 ± 553171 ± 568368 ± 79455.9 ± 665973 ± 874372 ± 312723 ± 39
AUCtau1 on Day 28331.1 ± 40671.1 ± 351153 ± 443534 ± 87190.8 ± 602249 ± 88NA ± NANA ± NA
AUCtau2 on Day 28534.7 ± 46960.1 ± 731970 ± 684852 ± 74261.0 ± 723668 ± 91NA ± NANA ± NA
SecondaryMaximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28

For BID dosing, parameters were calculated for both dosing intervals (0-10 hr = interval 1 and 10-24 hr = interval 2) and were displayed as Cmax1, Cmax2. Cmax1: maximum plasma concentration during the dosing interval τ1 =0 to 10 hours. Cmax2: maximum plasma concentration during the dosing interval τ2=10 to 24 hours.

Time frame:
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28
Reported as:
Geometric mean · nanogram/milliliter (ng/mL)
Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
nanogram/milliliter (ng/mL)PF-06882961 15mg BID (Cohort 1)PF-06882961 50mg BID (Cohort 2)PF-06882961 70mg BID (Cohort 3)PF-06882961 120mg BID (Cohort 4)PF-06882961 10mg BID (Cohort 5)PF-06882961 120mg BID ST (Cohort 6)PF-06882961 200mg QD CR (Cohort 7)PF-06882961 120mg QD (Cohort 8)
Cmax on Day 150.58 ± 40124.4 ± 5149.75 ± 5051.61 ± 5015.02 ± 7026.02 ± 3928.67 ± 8720.40 ± 29
Cmax1 on Day 142.69 ± 29119.1 ± 5645.01 ± 4836.51 ± 4312.82 ± 5824.06 ± 42NA ± NANA ± NA
Cmax2 on Day 140.63 ± 6668.77 ± 5142.33 ± 5944.97 ± 6113.98 ± 7521.64 ± 41NA ± NANA ± NA
Cmax on Day 14 or 2165.78 ± 35149.8 ± 88253.6 ± 76788.4 ± 8918.63 ± 47188.5 ± 5798.11 ± 54100.7 ± 35
Cmax1 on Day 14 or 2155.00 ± 43130.2 ± 85235.1 ± 84682.7 ± 9215.31 ± 50143.0 ± 71NA ± NANA ± NA
Cmax2 on Day 14 or 2163.89 ± 36127.9 ± 86202.8 ± 50505.3 ± 9317.16 ± 58178.4 ± 56NA ± NANA ± NA
Cmax on Day 2881.56 ± 32133.7 ± 69328.8 ± 49685.2 ± 8738.38 ± 58437.6 ± 94303.9 ± 32192.2 ± 52
Cmax1 on Day 2850.24 ± 44103.8 ± 50197.9 ± 51649.2 ± 9030.42 ± 52357.1 ± 84NA ± NANA ± NA
Cmax2 on Day 2874.22 ± 37117.2 ± 63306.5 ± 49617.9 ± 9335.01 ± 56410.3 ± 90NA ± NANA ± NA
SecondaryTime for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28

Time for Cmax, Cmax1 and Cmax2 (Tmax, Tmax1 and Tmax2) of PF-06293620 was observed directly from data as time of first occurrence.

Time frame:
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
Reported as:
Median · hours
Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
hoursPF-06882961 15mg BID (Cohort 1)PF-06882961 50mg BID (Cohort 2)PF-06882961 70mg BID (Cohort 3)PF-06882961 120mg BID (Cohort 4)PF-06882961 10mg BID (Cohort 5)PF-06882961 120mg BID ST (Cohort 6)PF-06882961 200mg QD CR (Cohort 7)PF-06882961 120mg QD (Cohort 8)
Tmax on Day 1NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)13.0 (8.00 to 23.9)3.00 (1.00 to 6.00)
Tmax1 on Day 14.00 (2.00 to 8.00)4.00 (1.00 to 6.00)2.00 (1.00 to 6.00)4.00 (2.00 to 6.00)2.00 (1.00 to 2.00)2.00 (1.00 to 4.00)NA (NA to NA)NA (NA to NA)
Tmax2 on Day 114.0 (10.0 to 24.0)14.0 (10.0 to 24.0)14.0 (12.0 to 14.0)14.0 (12.0 to 24.0)12.0 (12.0 to 14.0)14.0 (12.0 to 24.0)NA (NA to NA)NA (NA to NA)
Tmax on Day 14 or 21NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)12.0 (6.00 to 14.0)6.00 (4.00 to 10.0)
Tmax1 on Day 14 or 214.00 (2.00 to 8.00)4.00 (1.00 to 6.00)1.05 (1.00 to 6.00)1.54 (1.00 to 6.00)6.00 (1.00 to 6.00)6.00 (4.00 to 10.0)NA (NA to NA)NA (NA to NA)
Tmax2 on Day 14 or 2113.0 (12.0 to 14.0)13.0 (10.0 to 14.0)12.0 (12.0 to 12.0)12.0 (10.0 to 14.0)12.0 (12.0 to 14.0)14.0 (12.0 to 24.0)NA (NA to NA)NA (NA to NA)
Tmax on Day 28NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)14.0 (8.00 to 14.0)10.0 (6.00 to 14.0)
Tmax1 on Day 285.00 (4.00 to 8.00)3.00 (0.00 to 8.00)6.00 (2.00 to 8.00)4.00 (1.00 to 6.00)4.00 (2.00 to 8.00)6.00 (4.00 to 10.0)NA (NA to NA)NA (NA to NA)
Tmax2 on Day 2812.0 (12.0 to 14.0)12.0 (12.0 to 12.0)12.0 (12.0 to 14.0)12.0 (12.0 to 14.0)12.0 (12.0 to 14.0)12.0 (10.0 to 14.0)NA (NA to NA)NA (NA to NA)
SecondaryTerminal Half-life (t½) of PF-06882961 on Day 28

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame:
0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28
Reported as:
Mean · hours
Terminal Half-life (t½) of PF-06882961 on Day 28
hoursPF-06882961 15mg BID (Cohort 1)PF-06882961 50mg BID (Cohort 2)PF-06882961 70mg BID (Cohort 3)PF-06882961 120mg BID (Cohort 4)PF-06882961 10mg BID (Cohort 5)PF-06882961 120mg BID ST (Cohort 6)PF-06882961 200mg QD CR (Cohort 7)PF-06882961 120mg QD (Cohort 8)
Terminal Half-life (t½) of PF-06882961 on Day 285.100 ± 1.21865.067 ± 0.755934.681 ± 0.595046.203 ± 2.35058.090 ± 3.32346.730 ± 2.50565.773 ± 1.48764.954 ± 0.58819
SecondaryAmount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28

Ae was the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval was 24 hours. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram \[g\]/1.020), where 1.020 g/mL was the approximate specific gravity of urine.

Time frame:
0 to 24 hours post-dose on Day 28
Reported as:
Geometric mean · microgram
Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28
microgramPF-06882961 15mg BID (Cohort 1)PF-06882961 50mg BID (Cohort 2)PF-06882961 70mg BID (Cohort 3)PF-06882961 120mg BID (Cohort 4)PF-06882961 10mg BID (Cohort 5)PF-06882961 120mg BID ST (Cohort 6)PF-06882961 200mg QD CR (Cohort 7)PF-06882961 120mg QD (Cohort 8)
Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 2817.25 ± 3633.60 ± 6941.16 ± 243NA ± NA14.97 ± 6762.63 ± 43972.98 ± 3849.09 ± 97
SecondaryAe24 (%) of PF-06882961 on Day 28

Percent of dose recovered in urine as unchanged drug. Ae24% = 100\* Ae24/Dose

Time frame:
0 to 24 hours post-dose on Day 28
Reported as:
Geometric mean · Percentage
Ae24 (%) of PF-06882961 on Day 28
PercentagePF-06882961 15mg BID (Cohort 1)PF-06882961 50mg BID (Cohort 2)PF-06882961 70mg BID (Cohort 3)PF-06882961 120mg BID (Cohort 4)PF-06882961 10mg BID (Cohort 5)PF-06882961 120mg BID ST (Cohort 6)PF-06882961 200mg QD CR (Cohort 7)PF-06882961 120mg QD (Cohort 8)
Ae24 (%) of PF-06882961 on Day 280.05747 ± 360.03360 ± 690.02942 ± 242NA ± NA0.07483 ± 670.02607 ± 4390.03652 ± 380.04094 ± 97
SecondaryRenal Clearance (CLr) of PF-06882961 on Day 28

CLr was calculated as Ae divided by AUCtau, where dosing interval is 24 hours.

Time frame:
0 to 24 hours post-dose on Day 28
Reported as:
Geometric mean · mL/min
Renal Clearance (CLr) of PF-06882961 on Day 28
mL/minPF-06882961 15mg BID (Cohort 1)PF-06882961 50mg BID (Cohort 2)PF-06882961 70mg BID (Cohort 3)PF-06882961 120mg BID (Cohort 4)PF-06882961 10mg BID (Cohort 5)PF-06882961 120mg BID ST (Cohort 6)PF-06882961 200mg QD CR (Cohort 7)PF-06882961 120mg QD (Cohort 8)
Renal Clearance (CLr) of PF-06882961 on Day 280.3273 ± 180.3385 ± 180.3094 ± 70NA ± NA0.5470 ± 260.2006 ± 2280.2895 ± 210.3178 ± 73

Adverse events

Collected over Baseline up to 35 days after last dose for a total of approximately 63 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/25 (0%)0/25 (0%)15/25 (60%)
PF-06882961 10mg BID0/9 (0%)0/9 (0%)6/9 (66.7%)
PF-06882961 15mg BID0/9 (0%)0/9 (0%)8/9 (88.9%)
PF-06882961 50mg BID0/10 (0%)0/10 (0%)10/10 (100%)
PF-06882961 70mg BID0/9 (0%)0/9 (0%)8/9 (88.9%)
PF-06882961 120mg BID0/9 (0%)0/9 (0%)8/9 (88.9%)
PF-06882961 120mg BID ST0/9 (0%)1/9 (11.1%)9/9 (100%)
PF-06882961 120mg QD0/8 (0%)0/8 (0%)8/8 (100%)
PF-06882961 200mg QD CR0/10 (0%)0/10 (0%)9/10 (90%)
Most frequent serious events
Most frequent serious events
EventPlaceboPF-06882961 10mg BIDPF-06882961 15mg BIDPF-06882961 50mg BIDPF-06882961 70mg BIDPF-06882961 120mg BIDPF-06882961 120mg BID STPF-06882961 120mg QDPF-06882961 200mg QD CR
Acute myocardial infarctionCardiac disorders0/250/90/90/100/90/91/90/80/10
Most frequent other events
Showing 10 of 58
Most frequent other events
EventPlaceboPF-06882961 10mg BIDPF-06882961 15mg BIDPF-06882961 50mg BIDPF-06882961 70mg BIDPF-06882961 120mg BIDPF-06882961 120mg BID STPF-06882961 120mg QDPF-06882961 200mg QD CR
NauseaGastrointestinal disorders4/250/92/97/103/98/99/97/88/10
DyspepsiaGastrointestinal disorders4/250/90/95/104/94/97/93/85/10
VomitingGastrointestinal disorders2/250/90/92/102/97/97/93/83/10
ConstipationGastrointestinal disorders3/252/92/91/102/91/96/91/82/10
Decreased appetiteMetabolism and nutrition disorders1/250/90/91/101/96/92/93/85/10
Early satietyGeneral disorders2/251/90/95/101/90/92/91/82/10
HeadacheNervous system disorders8/250/91/95/102/90/90/94/83/10
DiarrhoeaGastrointestinal disorders5/250/93/92/103/94/91/92/84/10
Abdominal distensionGastrointestinal disorders0/250/90/90/103/90/90/92/80/10
FatigueGeneral disorders1/250/90/93/100/90/90/90/80/10

Baseline characteristics

All randomized participants who received at least 1 dose of randomized study treatment.

Age, Customized
Age, Customized(Participants)PlaceboPF-06882961 10mg BIDPF-06882961 15mg BIDPF-06882961 50mg BIDPF-06882961 70mg BIDPF-06882961 120mg BIDPF-06882961 120mg BID STPF-06882961 120mg QDPF-06882961 200mg QD CRTotal
18-44 years1110010004
45-64 years198668877877
>=65 years50241021217
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboPF-06882961 10mg BIDPF-06882961 15mg BIDPF-06882961 50mg BIDPF-06882961 70mg BIDPF-06882961 120mg BIDPF-06882961 120mg BID STPF-06882961 120mg QDPF-06882961 200mg QD CRTotal
Female132655254547
Male127354744551
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboPF-06882961 10mg BIDPF-06882961 15mg BIDPF-06882961 50mg BIDPF-06882961 70mg BIDPF-06882961 120mg BIDPF-06882961 120mg BID STPF-06882961 120mg QDPF-06882961 200mg QD CRTotal
Hispanic or Latino186476446661
Not Hispanic or Latino73533552437
Unknown or Not Reported0000000000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboPF-06882961 10mg BIDPF-06882961 15mg BIDPF-06882961 50mg BIDPF-06882961 70mg BIDPF-06882961 120mg BIDPF-06882961 120mg BID STPF-06882961 120mg QDPF-06882961 200mg QD CRTotal
White187587648770
Black or African American72322350327
Native Hawaiian or Other Pacific Islander0010000001
Age Range
Age Range(Years)PlaceboPF-06882961 10mg BIDPF-06882961 15mg BIDPF-06882961 50mg BIDPF-06882961 70mg BIDPF-06882961 120mg BIDPF-06882961 120mg BID STPF-06882961 120mg QDPF-06882961 200mg QD CRTotal
Median60.0 (41 to 70)55.0 (44 to 61)55.0 (37 to 68)63.5 (48 to 68)60.0 (46 to 65)57.0 (40 to 64)58.0 (50 to 69)58.0 (53 to 66)59.0 (45 to 69)58.0 (37 to 70)
08

Study locations

4 sites
  • Anaheim Clinical Trials, LLC
    Anaheim, California 92801, United States
  • Qps-Mra, Llc
    South Miami, Florida 33143, United States
  • Qps-Mra,Llc
    South Miami, Florida 33143, United States
  • Altasciences Clinical Kansas, Inc.
    Overland Park, Kansas 66212, United States
09

References and documents

Publications

  • Saxena AR, Gorman DN, Esquejo RM, Bergman A, Chidsey K, Buckeridge C, Griffith DA, Kim AM. Danuglipron (PF-06882961) in type 2 diabetes: a randomized, placebo-controlled, multiple ascending-dose phase 1 trial. Nat Med. 2021 Jun;27(6):1079-1087. doi: 10.1038/s41591-021-01391-w. Epub 2021 Jun 14. PubMed 34127852 ↗

Study documents

  • Study protocol · Mar 22, 2018
  • Statistical analysis plan · Jun 19, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03538743
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
May 29, 2018
Start date
Jun 25, 2018
Primary completion
May 23, 2019
Completion
Jun 10, 2019
Results posted
Jul 1, 2020
Last update
Jul 1, 2020

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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