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NCT04617275

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

Completed Phase 2 Results posted Last updated 8 December 2022
What this trial tests

Phase 2 trial testing PF-06882961 in Diabetes in 151 participants. Completed in 17 November 2021.

Timeline
6 January 2021
Primary endpoint
17 November 2021
17 November 2021

Quick facts

Lead sponsorPfizer
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment151
Start date6 January 2021
Primary completion17 November 2021
Estimated completion17 November 2021
Sites38 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

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 Severity Primary · 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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.

GroupValue95% 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 Criteria Secondary · 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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 Criteria Secondary · 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
GroupValue95% 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%
GroupValue95% 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
GroupValue95% 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%
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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
GroupValue95% 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 2 Secondary · 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.

GroupValue95% 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 4 Secondary · 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.

GroupValue95% 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 6 Secondary · 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.

GroupValue95% 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 8 Secondary · 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.

GroupValue95% 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 10 Secondary · 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.

GroupValue95% 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 12 Secondary · 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.

GroupValue95% 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.

Placebo (T2DM)
Serious: 0/16 (0%)
Deaths: 0/16
Placebo (Non-diabetic Obesity)
Serious: 0/6 (0%)
Deaths: 0/6
PF-06882961 80 mg BID Low, Slow (T2DM)
Serious: 0/20 (0%)
Deaths: 0/20
PF-06882961 80 mg BID High, Slow (T2DM)
Serious: 0/22 (0%)
Deaths: 0/22
PF-06882961 120 mg BID Low, Fast (T2DM)
Serious: 0/22 (0%)
Deaths: 0/22
PF-06882961 120 mg BID High, Fast (T2DM)
Serious: 0/22 (0%)
Deaths: 0/22
PF-06882961 200 mg BID (T2DM)
Serious: 0/21 (0%)
Deaths: 0/21
PF-06882961 200 mg BID (Non-diabetic Obesity)
Serious: 0/22 (0%)
Deaths: 0/22
Other adverse events (45 terms — click to expand)

ReactionSystemPlacebo (T2DM)Placebo (Non-diabetic Obes…PF-06882961 80 mg BID Low,…PF-06882961 80 mg BID High…PF-06882961 120 mg BID Low…PF-06882961 120 mg BID Hig…PF-06882961 200 mg BID (T2…PF-06882961 200 mg BID (No…
NauseaGastrointestinal disorders
VomitingGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
DyspepsiaGastrointestinal disorders
Decreased appetiteMetabolism and nutrition disorders
DizzinessNervous system disorders
Abdominal pain upperGastrointestinal disorders
HypoglycaemiaMetabolism and nutrition disorders
HeadacheNervous system disorders
PalpitationsCardiac disorders
Abdominal distensionGastrointestinal disorders
Abdominal painGastrointestinal disorders
ConstipationGastrointestinal disorders
EructationGastrointestinal disorders
Gastrooesophageal reflux diseaseGastrointestinal disorders
FatigueGeneral disorders
Urinary tract infectionInfections and infestations
Muscle strainInjury, poisoning and procedural complications
Blood triglycerides increasedInvestigations
Weight decreasedInvestigations
ArthralgiaMusculoskeletal and connective tissue disorders
PingueculaEye disorders
Faeces discolouredGastrointestinal disorders
Food poisoningGastrointestinal disorders
AstheniaGeneral disorders
Chest discomfortGeneral disorders
Chest painGeneral disorders
Pre-existing condition improvedGeneral disorders
GastroenteritisInfections and infestations
Gastroenteritis viralInfections and infestations
Infected biteInfections and infestations
Upper respiratory tract infectionInfections and infestations
Electrocardiogram QT prolongedInvestigations
DyslipidaemiaMetabolism and nutrition disorders
Musculoskeletal chest painMusculoskeletal and connective tissue disorders
Musculoskeletal stiffnessMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
AmnesiaNervous system disorders
Neuropathy peripheralNervous system disorders
ParaesthesiaNervous system disorders

Data from ClinicalTrials.gov NCT04617275 adverse events section.

Sponsor's own description

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):

  1. Signaling pathways in obesity: mechanisms and therapeutic interventions.
    Wen X, Zhang B, Wu B, Xiao H, et al · · 2022 · cited 245× · PMID 36031641 · DOI 10.1038/s41392-022-01149-x
  2. Tolerability, safety and pharmacodynamics of oral, small-molecule glucagon-like peptide-1 receptor agonist danuglipron for type 2 diabetes: A 12-week, randomized, placebo-controlled, Phase 2 study comparing different dose-escalation schemes.
    Saxena AR, Frias JP, Gorman DN, Lopez RN, et al · · 2023 · cited 31× · PMID 37311722 · DOI 10.1111/dom.15168
  3. Molecular Mechanisms behind Obesity and Their Potential Exploitation in Current and Future Therapy.
    Nicze M, Dec A, Borówka M, Krzyżak D, et al · · 2024 · cited 9× · PMID 39125772 · DOI 10.3390/ijms25158202
  4. Efficacy and safety of danuglipron (PF-06882961) in adults with obesity: A randomized, placebo-controlled, dose-ranging phase 2b study.
    Buckeridge C, Cobain S, Bays HE, Matsuoka O, et al · · 2025 · cited 8× · PMID 40539310 · DOI 10.1111/dom.16534
  5. 58<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : Stockholm, Sweden, 19 - 23 September 2022.
    · 2022 · cited 6× · PMID 35920845 · DOI 10.1007/s00125-022-05755-w
  6. Small-Molecule GLP-1 Receptor Agonists: A Promising Pharmacological Approach.
    Șeremet OC, Pușcașu C, Andrei C, Nițulescu G, et al · · 2025 · cited 1× · PMID 41303737 · DOI 10.3390/medicina61111902

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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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing