CompletedPhase 1Results posted

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

AN 8-WEEK PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF TWICE DAILY PF-06882961 ADMINISTRATION IN JAPANESE ADULTS WITH TYPE 2 DIABETES MELLITUS

Lead sponsor

Pfizer

Asset

Danuglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI 22.5-45.4•HbA1c ≥7%

Primary endpoints

•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))•Clinical Laboratory Abnormalities•Absolute Vital Signs Values (Systolic BP, change, Diastolic BP, change, Heart rate, change)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04552470

Org study IDC3421015

Timeline

Milestones

Study first posted2020-09-17actual

Study start2020-10-26actual

Primary completion2021-03-25actual

Study completion2021-03-25actual

Last update posted2022-03-11actual

Results first posted2022-03-11actual

Assets

Investigational agents

Danuglipron

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age20 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with T2DM who are treated with diet and exercise

•HbA1c greater than or equal to 7% and less than or equal to 10.5%

•Total body weight >50 kg (110 lb) with BMI 22.5 to 45.4 kg/m^2

Exclusion criteria

•Any condition possibly affecting drug absorption

•Diagnosis of Type 1 diabetes

•History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening

•Any malignancy not considered cured

•Personal or family history of MTC or MEN2, or participants with suspected MTC

•Acute pancreatitis or history of chronic pancreatitis

•Symptomatic gallbladder disease

•Known medical history of active proliferative retinopathy and/or macular edema

•Known history of HIV, hepatitis B, hepatitis C or syphilis

•Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)

•Clinically relevant ECG abnormalities

•Positive urine drug test

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Posted result

Group	Participants	95% CI
PlaceboParticipants with AEs	3	-
Participants with SAEs	0	-
PF-06882961 40 mgParticipants with AEs	7	-
Participants with SAEs	0	-
PF-06882961 80 mgParticipants with AEs	9	-
Participants with SAEs	0	-
PF-06882961 120 mgParticipants with AEs	9	-
Participants with SAEs	0	-

Primary/protocol endpoint

Number of Participants With Clinical Laboratory Abnormalities

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

threshold achievement, event

Posted result

Group	Participants	95% CI
Placebo	9	-
PF-06882961 40 mg	10	-
PF-06882961 80 mg	8	-
PF-06882961 120 mg	9	-

Primary/protocol endpoint

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

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

threshold achievement, event

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Posted result

Group	Participants	95% CI
PlaceboMinimum of absolute SBP <90 mmHg	0	-
Maximum of SBP >=30 mmHg decrease	1	-
Maximum of SBP >=30 mmHg increase	3	-
Minimum of absolute DBP <50 mmHg	0	-
Maximum of DBP >=20 mmHg decrease	0	-
Maximum of DBP >=20 mmHg increase	1	-
Minimum of absolute pulse rate <40 BPM	0	-
Maximum of absolute pulse rate >120 BPM	0	-
PF-06882961 40 mgMinimum of absolute SBP <90 mmHg	0	-
Maximum of SBP >=30 mmHg decrease	0	-
Maximum of SBP >=30 mmHg increase	2	-
Minimum of absolute DBP <50 mmHg	0	-
Maximum of DBP >=20 mmHg decrease	0	-
Maximum of DBP >=20 mmHg increase	2	-
Minimum of absolute pulse rate <40 BPM	0	-
Maximum of absolute pulse rate >120 BPM	0	-
PF-06882961 80 mgMinimum of absolute SBP <90 mmHg	0	-
Maximum of SBP >=30 mmHg decrease	0	-
Maximum of SBP >=30 mmHg increase	3	-
Minimum of absolute DBP <50 mmHg	0	-
Maximum of DBP >=20 mmHg decrease	0	-
Maximum of DBP >=20 mmHg increase	3	-
Minimum of absolute pulse rate <40 BPM	0	-
Maximum of absolute pulse rate >120 BPM	0	-
PF-06882961 120 mgMinimum of absolute SBP <90 mmHg	0	-
Maximum of SBP >=30 mmHg decrease	1	-
Maximum of SBP >=30 mmHg increase	2	-
Minimum of absolute DBP <50 mmHg	0	-
Maximum of DBP >=20 mmHg decrease	0	-
Maximum of DBP >=20 mmHg increase	3	-
Minimum of absolute pulse rate <40 BPM	0	-
Maximum of absolute pulse rate >120 BPM	0	-

Primary/protocol endpoint

Number of Participants With Absolute Electrocardiogram (ECG) Values and Increased ECG Values From Time-Matched Baseline

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

threshold achievement, event

Posted result

Group	Participants	95% CI
PlaceboMaximum absolute PR >=300 msec	0	-
Baseline PR >200 msec and maximum increase in PR >=25%	0	-
Baseline PR <=200 msec and maximum increase in PR >=50%	0	-
Maximum absolute QRS >=140 msec	0	-
Maximum increase in QRS >=50%	0	-
Absolute QTCF interval >450 msec to <=480 msec	1	-
Absolute QTCF interval >480 msec to <=500 msec	0	-
Absolute QTCF >500 msec	0	-
QTCF increase >=30 msec to <=60 msec	0	-
QTCF increase >60 msec	0	-
PF-06882961 40 mgMaximum absolute PR >=300 msec	0	-
Baseline PR >200 msec and maximum increase in PR >=25%	0	-
Baseline PR <=200 msec and maximum increase in PR >=50%	0	-
Maximum absolute QRS >=140 msec	0	-
Maximum increase in QRS >=50%	0	-
Absolute QTCF interval >450 msec to <=480 msec	0	-
Absolute QTCF interval >480 msec to <=500 msec	0	-
Absolute QTCF >500 msec	0	-
QTCF increase >=30 msec to <=60 msec	0	-
QTCF increase >60 msec	0	-
PF-06882961 80 mgMaximum absolute PR >=300 msec	0	-
Baseline PR >200 msec and maximum increase in PR >=25%	0	-
Baseline PR <=200 msec and maximum increase in PR >=50%	0	-
Maximum absolute QRS >=140 msec	0	-
Maximum increase in QRS >=50%	0	-
Absolute QTCF interval >450 msec to <=480 msec	1	-
Absolute QTCF interval >480 msec to <=500 msec	0	-
Absolute QTCF >500 msec	0	-
QTCF increase >=30 msec to <=60 msec	0	-
QTCF increase >60 msec	0	-
PF-06882961 120 mgMaximum absolute PR >=300 msec	0	-
Baseline PR >200 msec and maximum increase in PR >=25%	0	-
Baseline PR <=200 msec and maximum increase in PR >=50%	0	-
Maximum absolute QRS >=140 msec	0	-
Maximum increase in QRS >=50%	0	-
Absolute QTCF interval >450 msec to <=480 msec	1	-
Absolute QTCF interval >480 msec to <=500 msec	0	-
Absolute QTCF >500 msec	0	-
QTCF increase >=30 msec to <=60 msec	0	-
QTCF increase >60 msec	0	-

Secondary/protocol endpoint

Area Under the Plasma Concentration-time Profile From Zero to Time 24 Hours (AUC24) of PF-06882961

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

AUC₀-∞

concentration, descriptive

Posted result

Group	Geometric mean · Nanogram*hour per milliliter	95% CI
PF-06882961 40 mgDay 1	414.4	-
Day 56	2424	-
PF-06882961 80 mgDay 1	500.3	-
Day 56	4691	-
PF-06882961 120 mgDay 1	484.5	-
Day 56	6953	-

Secondary/protocol endpoint

Maximum Plasma Concentration (Cmax) Observed of PF-06882961

Time frame: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

Cmax

concentration, descriptive

Posted result

Group	Geometric mean · Nanogram per milliliter	95% CI
PF-06882961 40 mgDay 1	32.83	-
Day 56	206.1	-
PF-06882961 80 mgDay 1	45.89	-
Day 56	352.2	-
PF-06882961 120 mgDay 1	39.35	-
Day 56	551.7	-

Secondary/protocol endpoint

Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06882961

Time frame: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

Tmax

descriptive

Posted result

Group	Median · Hours	95% CI
PF-06882961 40 mgDay 1	12.0	2.00 - 23.8
Day 56	12.0	6.00 - 13.8
PF-06882961 80 mgDay 1	12.0	1.00 - 12.0
Day 56	12.9	2.00 - 36.0
PF-06882961 120 mgDay 1	12.0	1.00 - 14.0
Day 56	12.0	0.000 - 13.8

Secondary/protocol endpoint

Terminal Phase Half-Life (t1/2) of PF-06882961

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

Half-life

descriptive

Posted result

Group	Mean · Hours	95% CI
PF-06882961 40 mg	6.373	-
PF-06882961 80 mg	5.543	-
PF-06882961 120 mg	5.300	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.