A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY
CompletedPhase 2Results postedLast updated 8 December 2022
What this trial tests
Phase 2 trial testing PF-06882961 in Diabetes in 151 participants. Completed in 17 November 2021.
Adults 18 to 75, any sex, with Diabetes or Obesity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment Emergent Adverse Events (AEs) by SeverityPrimary· Baseline through follow-up (Day 112)
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE. Assessments of AE intensity were defined as mild (ea
All Causality - Mild
Group
Value
95% CI
Placebo (T2DM)
5
PF-06882961 80 mg BID Low, Slow (T2DM)
4
PF-06882961 80 mg BID High, Slow (T2DM)
10
PF-06882961 120 mg BID Low, Fast (T2DM)
9
PF-06882961 120 mg BID High, Fast (T2DM)
8
PF-06882961 200 mg BID (T2DM)
10
Placebo (Non-diabetic Obesity)
1
PF-06882961 200 mg BID (Non-diabetic Obesity)
6
All Causality - Moderate
Group
Value
95% CI
Placebo (T2DM)
3
PF-06882961 80 mg BID Low, Slow (T2DM)
8
PF-06882961 80 mg BID High, Slow (T2DM)
3
PF-06882961 120 mg BID Low, Fast (T2DM)
5
PF-06882961 120 mg BID High, Fast (T2DM)
6
PF-06882961 200 mg BID (T2DM)
3
Placebo (Non-diabetic Obesity)
3
PF-06882961 200 mg BID (Non-diabetic Obesity)
11
All Causality - Severe
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
1
PF-06882961 120 mg BID Low, Fast (T2DM)
2
PF-06882961 120 mg BID High, Fast (T2DM)
1
PF-06882961 200 mg BID (T2DM)
1
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
1
Treatment Related - Mild
Group
Value
95% CI
Placebo (T2DM)
2
PF-06882961 80 mg BID Low, Slow (T2DM)
4
PF-06882961 80 mg BID High, Slow (T2DM)
8
PF-06882961 120 mg BID Low, Fast (T2DM)
3
PF-06882961 120 mg BID High, Fast (T2DM)
7
PF-06882961 200 mg BID (T2DM)
9
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
5
Treatment Related - Moderate
Group
Value
95% CI
Placebo (T2DM)
2
PF-06882961 80 mg BID Low, Slow (T2DM)
4
PF-06882961 80 mg BID High, Slow (T2DM)
2
PF-06882961 120 mg BID Low, Fast (T2DM)
3
PF-06882961 120 mg BID High, Fast (T2DM)
7
PF-06882961 200 mg BID (T2DM)
3
Placebo (Non-diabetic Obesity)
1
PF-06882961 200 mg BID (Non-diabetic Obesity)
11
Treatment Related - Severe
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
2
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
1
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
1
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)Secondary· Baseline through Visit 10 (Day 91)
Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion.
Group
Value
95% CI
Placebo (T2DM)
12
PF-06882961 80 mg BID Low, Slow (T2DM)
16
PF-06882961 80 mg BID High, Slow (T2DM)
17
PF-06882961 120 mg BID Low, Fast (T2DM)
20
PF-06882961 120 mg BID High, Fast (T2DM)
17
PF-06882961 200 mg BID (T2DM)
14
Placebo (Non-diabetic Obesity)
4
PF-06882961 200 mg BID (Non-diabetic Obesity)
9
Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization CriteriaSecondary· Baseline through Visit 10 (Day 91)
Vital signs abnormality 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 \>=30 mmHg; 5) change from baseline (increase or decrease) in supine DBP \>=20 mmHg.
Supine SBP <90 mmHg
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Supine SBP Increase >=30 mmHg
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
2
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
4
PF-06882961 200 mg BID (T2DM)
1
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Supine SBP Decrease >=30 mmHg
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
2
PF-06882961 80 mg BID High, Slow (T2DM)
1
PF-06882961 120 mg BID Low, Fast (T2DM)
3
PF-06882961 120 mg BID High, Fast (T2DM)
2
PF-06882961 200 mg BID (T2DM)
1
Placebo (Non-diabetic Obesity)
1
PF-06882961 200 mg BID (Non-diabetic Obesity)
2
Supine DBP <50 mmHg
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Supine DBP Increase >=20 mmHg
Group
Value
95% CI
Placebo (T2DM)
1
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
2
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
2
PF-06882961 200 mg BID (T2DM)
1
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Supine DBP Decrease >=20 mmHg
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
1
PF-06882961 80 mg BID High, Slow (T2DM)
1
PF-06882961 120 mg BID Low, Fast (T2DM)
1
PF-06882961 120 mg BID High, Fast (T2DM)
1
PF-06882961 200 mg BID (T2DM)
1
Placebo (Non-diabetic Obesity)
1
PF-06882961 200 mg BID (Non-diabetic Obesity)
1
Supine Pulse Rate <40 bpm
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Supine Pulse Rate >120 bpm
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization CriteriaSecondary· Baseline through Visit 10 (Day 91)
ECG assessments included pulse rate (PR), QT, heart rate, QTcF intervals and QRS complex. ECG abnormalities criteria included: PR interval value \>= 300 msec, or baseline (BL) \>200 msec and \>=25% increase from BL, or BL \<=200 msec and \>=50% increase from BL; QRS interval value \>= 140msec, or \>=50% increase from BL; QTcF value \>450 and \<=480 msec, or \>480 and \<=500 msec, or \>500 msec, or increase from BL\>30 and \<=60 msec, or \>60msec.
PR interval >=300 msec
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
%Change in PR interval >=25/50%
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
QRS interval >=140 msec
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
%Change in QRS interval >=50%
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
QTcF interval >450 and <=480 msec
Group
Value
95% CI
Placebo (T2DM)
1
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
2
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
Placebo (Non-diabetic Obesity)
1
PF-06882961 200 mg BID (Non-diabetic Obesity)
1
QTcF interval >480 and <=500 msec
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
Placebo (Non-diabetic Obesity)
1
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
QTcF interval >500 msec
Group
Value
95% CI
Placebo (T2DM)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Change in QTcF interval >30 and <=60 msec
Group
Value
95% CI
Placebo (T2DM)
2
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
1
PF-06882961 120 mg BID High, Fast (T2DM)
3
PF-06882961 200 mg BID (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)Secondary· Week 0, 2, 4, 6, 8, 10, 12, 13-14
The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. Participants who responded "yes" to the questions will be counted. Data relevant to the assessment of suicidality were mapped to the Columbia-Classification Algorithm of Suicide Assessment (C-CASA) codes.
Week 0 - <1> Completed Suicide
Group
Value
95% CI
Placebo (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Week 0 - <2> Suicide Attempt
Group
Value
95% CI
Placebo (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Week 0 - <3> Preparatory Acts Towards Imminent Suicidal Behavior
Group
Value
95% CI
Placebo (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Week 0 - <4> Suicidal Ideation
Group
Value
95% CI
Placebo (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Week 0 - <7> Self-injurious Behavior, No Suicidal Intent
Group
Value
95% CI
Placebo (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Week 2 - <1> Completed Suicide
Group
Value
95% CI
Placebo (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Week 2 - <2> Suicide Attempt
Group
Value
95% CI
Placebo (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Week 2 - <3> Preparatory Acts Towards Imminent Suicidal Behavior
Group
Value
95% CI
Placebo (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)Secondary· Week 0, 2, 4, 6, 8, 10, 12, 13-14.
The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The PHQ-9 were completed by participants and reviewed by site staff at the pre-defined time points.
Week 0 - Little Interest/Pleasure in Things - Not At All
Group
Value
95% CI
Placebo (T2DM)
15
Placebo (Non-diabetic Obesity)
6
PF-06882961 80 mg BID Low, Slow (T2DM)
16
PF-06882961 80 mg BID High, Slow (T2DM)
20
PF-06882961 120 mg BID Low, Fast (T2DM)
20
PF-06882961 120 mg BID High, Fast (T2DM)
20
PF-06882961 200 mg BID (T2DM)
19
PF-06882961 200 mg BID (Non-diabetic Obesity)
21
Week 0 - Little Interest/Pleasure in Things - Several Days
Group
Value
95% CI
Placebo (T2DM)
1
Placebo (Non-diabetic Obesity)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
3
PF-06882961 80 mg BID High, Slow (T2DM)
1
PF-06882961 120 mg BID Low, Fast (T2DM)
1
PF-06882961 120 mg BID High, Fast (T2DM)
1
PF-06882961 200 mg BID (T2DM)
1
PF-06882961 200 mg BID (Non-diabetic Obesity)
1
Week 0 - Little Interest/Pleasure in Things - More Than Half the Days
Group
Value
95% CI
Placebo (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
1
PF-06882961 80 mg BID High, Slow (T2DM)
1
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
1
PF-06882961 200 mg BID (T2DM)
1
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Week 0 - Little Interest/Pleasure in Things - Nearly Every Day
Group
Value
95% CI
Placebo (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Week 0 - Feeling Down Depressed or Hopeless - Not At All
Group
Value
95% CI
Placebo (T2DM)
14
Placebo (Non-diabetic Obesity)
6
PF-06882961 80 mg BID Low, Slow (T2DM)
19
PF-06882961 80 mg BID High, Slow (T2DM)
18
PF-06882961 120 mg BID Low, Fast (T2DM)
19
PF-06882961 120 mg BID High, Fast (T2DM)
22
PF-06882961 200 mg BID (T2DM)
19
PF-06882961 200 mg BID (Non-diabetic Obesity)
19
Week 0 - Feeling Down Depressed or Hopeless - Several Days
Group
Value
95% CI
Placebo (T2DM)
2
Placebo (Non-diabetic Obesity)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
1
PF-06882961 80 mg BID High, Slow (T2DM)
3
PF-06882961 120 mg BID Low, Fast (T2DM)
1
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
2
PF-06882961 200 mg BID (Non-diabetic Obesity)
3
Week 0 - Feeling Down Depressed or Hopeless - More Than Half the Days
Group
Value
95% CI
Placebo (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
1
PF-06882961 120 mg BID Low, Fast (T2DM)
1
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Week 0 - Feeling Down Depressed or Hopeless - Nearly Every Day
Group
Value
95% CI
Placebo (T2DM)
0
Placebo (Non-diabetic Obesity)
0
PF-06882961 80 mg BID Low, Slow (T2DM)
0
PF-06882961 80 mg BID High, Slow (T2DM)
0
PF-06882961 120 mg BID Low, Fast (T2DM)
0
PF-06882961 120 mg BID High, Fast (T2DM)
0
PF-06882961 200 mg BID (T2DM)
0
PF-06882961 200 mg BID (Non-diabetic Obesity)
0
Change From Baseline (CFB) in Fasting Plasma Glucose at Week 2Secondary· Baseline, Week 2
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Group
Value
95% CI
Placebo (T2DM)
-5.63
-19.00 – 7.74
PF-06882961 80 mg BID Low, Slow (T2DM)
-3.32
-14.62 – 7.97
PF-06882961 80 mg BID High, Slow (T2DM)
-23.04
-34.05 – -12.03
PF-06882961 120 mg BID Low, Fast (T2DM)
-36.48
-47.44 – -25.52
PF-06882961 120 mg BID High, Fast (T2DM)
-39.29
-50.23 – -28.35
PF-06882961 200 mg BID (T2DM)
-25.15
-36.59 – -13.72
CFB in Fasting Plasma Glucose at Week 4Secondary· Baseline, Week 4
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Group
Value
95% CI
Placebo (T2DM)
-13.12
-26.88 – 0.64
PF-06882961 80 mg BID Low, Slow (T2DM)
-16.45
-28.11 – -4.79
PF-06882961 80 mg BID High, Slow (T2DM)
-32.77
-43.98 – -21.55
PF-06882961 120 mg BID Low, Fast (T2DM)
-45.92
-57.20 – -34.64
PF-06882961 120 mg BID High, Fast (T2DM)
-48.97
-60.52 – -37.42
PF-06882961 200 mg BID (T2DM)
-41.60
-53.38 – -29.83
CFB in Fasting Plasma Glucose at Week 6Secondary· Baseline, Week 6
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Group
Value
95% CI
Placebo (T2DM)
-3.75
-19.85 – 12.35
PF-06882961 80 mg BID Low, Slow (T2DM)
-29.33
-43.35 – -15.31
PF-06882961 80 mg BID High, Slow (T2DM)
-36.70
-50.13 – -23.27
PF-06882961 120 mg BID Low, Fast (T2DM)
-43.82
-57.90 – -29.75
PF-06882961 120 mg BID High, Fast (T2DM)
-49.22
-63.14 – -35.31
PF-06882961 200 mg BID (T2DM)
-37.38
-51.77 – -22.99
CFB in Fasting Plasma Glucose at Week 8Secondary· Baseline, Week 8
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Group
Value
95% CI
Placebo (T2DM)
-5.90
-20.83 – 9.04
PF-06882961 80 mg BID Low, Slow (T2DM)
-33.69
-47.42 – -19.96
PF-06882961 80 mg BID High, Slow (T2DM)
-31.57
-44.56 – -18.58
PF-06882961 120 mg BID Low, Fast (T2DM)
-52.84
-66.55 – -39.13
PF-06882961 120 mg BID High, Fast (T2DM)
-39.69
-53.63 – -25.75
PF-06882961 200 mg BID (T2DM)
-48.02
-62.47 – -33.57
CFB in Fasting Plasma Glucose at Week 10Secondary· Baseline, Week 10
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Group
Value
95% CI
Placebo (T2DM)
-23.39
-39.07 – -7.71
PF-06882961 80 mg BID Low, Slow (T2DM)
-36.24
-51.69 – -20.78
PF-06882961 80 mg BID High, Slow (T2DM)
-38.21
-52.17 – -24.26
PF-06882961 120 mg BID Low, Fast (T2DM)
-57.36
-72.43 – -42.29
PF-06882961 120 mg BID High, Fast (T2DM)
-22.08
-36.88 – -7.29
PF-06882961 200 mg BID (T2DM)
-37.81
-53.52 – -22.11
CFB in Fasting Plasma Glucose at Week 12Secondary· Baseline, Week 12
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Group
Value
95% CI
Placebo (T2DM)
-13.09
-29.75 – 3.57
PF-06882961 80 mg BID Low, Slow (T2DM)
-41.74
-58.49 – -25.00
PF-06882961 80 mg BID High, Slow (T2DM)
-40.41
-55.25 – -25.57
PF-06882961 120 mg BID Low, Fast (T2DM)
-53.94
-70.26 – -37.63
PF-06882961 120 mg BID High, Fast (T2DM)
-23.34
-39.52 – -7.17
PF-06882961 200 mg BID (T2DM)
-37.48
-55.27 – -19.69
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline through follow-up (Day 112-119)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will assess tolerability, safety, and pharmacodynamics (PD) of twice daily (BID) administration of PF- 06882961 in adult participants with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin and in non-diabetic adults with obesity
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06910839 — Study to Learn About How the Study Medicines Called PF-07976016 and PF-06882961 Are Taken Up by the Body, and if Either
· Phase 1
· terminated
NCT05093205 — STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETIC
· Phase 1
· completed
NCT04889157 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults Wit
· Phase 1
· completed
NCT04621227 — Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In
· Phase 1
· completed
NCT04552470 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults Wi
· Phase 1
· completed
Other recruiting trials for Diabetes
Currently open trials in the same condition.
NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass
· recruiting
NCT07479134 — Production of Stem Cells for the Generation of Pancreatic Cells
· NA
· recruiting
NCT07441655 — Families Implementing Good Health Traditions for Life
· NA
· recruiting
NCT06724172 — CHIME: Comparing Health Interventions for Maternal Equity
· NA
· recruiting
NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna®
· not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market
· not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea
· not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta
· Phase 1
· not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 8 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04617275.