CompletedPhase 1Results posted

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

AN 8-WEEK, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED PHASE 1 STUDY TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF PF-06882961 IN CHINESE 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

•AUC From Time 0•Cmax of PF-06882961 10 mg Single Dose on Day 1•AUC24 of PF-06882961

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 IDNCT04889157

Org study IDC3421028

Timeline

Milestones

Study first posted2021-05-17actual

Study start2021-07-07actual

Primary completion2022-02-17actual

Study completion2022-02-17actual

Last update posted2024-10-01actual

Results first posted2024-10-01actual

Assets

Investigational agents

Danuglipron

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age20 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with T2DM who are taking metformin monotherapy as their only antihyperglycemic treatment

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

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

Exclusion criteria

•Any condition possibly affecting drug absorption

•Diagnosis of Type 1 diabetes mellitus or secondary forms of 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

•Acute gallbladder disease

•Known history of HIV, hepatitis B, hepatitis C or syphilis, or positive testing of them

•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

•Clinical relevant laboratory tests abnormalities

Endpoints (16)

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

16 endpoints

Primary/registry result

Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1

Time frame:Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1

concentration, descriptive

Posted result

Group	Geometric mean · nanogramhour per milliter (nghr/mL)	95% CI
PF-06882961 10 mg Single Dose	287.4	-

Primary/registry result

Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1

Time frame:Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1

concentration, descriptive

Posted result

Group	Geometric mean · nanogram per milliter (ng/mL)	95% CI
PF-06882961 BID	37.37	-

Primary/registry result

AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961

Time frame:Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)

descriptive

Posted result

Group	Geometric mean · ng*hr/mL	95% CI
PF-06882961 40 mg BID	1446	-
PF-06882961 80 mg BID	1012	-
PF-06882961 120 mg BID	984.9	-

Primary/registry result

Maximum Observed Concentration, Steady State (Cmax,ss) of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961

Time frame:Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)

concentration, descriptive

Posted result

Group	Geometric mean · ng/mL	95% CI
PF-06882961 40 mg BID	150.3	-
PF-06882961 80 mg BID	98.92	-
PF-06882961 120 mg BID	110.5	-

Primary/protocol endpoint

Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC24) of PF-06882961 10 mg Single Dose on Day 1

Time frame:Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Maximum Observed Concentration (Cmax) of PF-06882961 10 mg Single Dose on Day 1

Time frame:Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 1

Cmax

concentration, descriptive

Primary/protocol endpoint

AUC24 of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961

Time frame:Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Maximum Observed Concentration, Steady State (Cmax,ss) of PF-06882961 in Participants Received 40 mg BID, 80 mg BID, and 120 mg BID PF-06882961

Time frame:Pre-dose, 1, 2, 4, 6, 8, 10, 12, 14, 24 hours post dose on Day 21 (40 mg BID), 35 (80 mg BID), and 56 (120 mg BID)

Cmax

concentration, descriptive

Secondary/registry result

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Time frame:Baseline up to 14 days after last dose (Day 70)

change from baseline, event

Posted result

Group	Participants	95% CI
PlaceboSupine systolic blood pressure (mmHg) change >=30 mm Hg increase	1	-
Supine systolic blood pressure (mmHg) change >=30 mm Hg decrease	0	-
Supine diastolic blood pressure (mmHg) change >=20 mm Hg increase	1	-
Supine diastolic blood pressure (mmHg) change >=20 mm Hg decrease	0	-
Supine pulse rate (beats per minute [bpm]) value >120 bpm	0	-
PF-06882961 BIDSupine systolic blood pressure (mmHg) change >=30 mm Hg increase	3	-
Supine systolic blood pressure (mmHg) change >=30 mm Hg decrease	2	-
Supine diastolic blood pressure (mmHg) change >=20 mm Hg increase	6	-
Supine diastolic blood pressure (mmHg) change >=20 mm Hg decrease	1	-
Supine pulse rate (beats per minute [bpm]) value >120 bpm	1	-

Secondary/registry result

Number of Participants With Abnormal Electrocardiogram (ECG)

Time frame:Baseline up to 14 days after last dose (Day 70)

event count, event

Posted result

Group	Participants	95% CI
PlaceboPR interval not otherwise specified (msec) %change >=50%	0	-
QTcF not otherwise specified (msec) 450 < Value <=480	1	-
PF-06882961 BIDPR interval not otherwise specified (msec) %change >=50%	1	-
QTcF not otherwise specified (msec) 450 < Value <=480	1	-

Secondary/registry result

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

Time frame:Baseline up to 35 days after last dose (Day 91)

event count, event

Posted result

Group	Participants	95% CI
PlaceboParticipants with non-serious AEs	5	-
Participants with serious adverse events	0	-
PF-06882961 BIDParticipants with non-serious AEs	14	-
Participants with serious adverse events	0	-

Secondary/registry result

Number of Participants With Laboratory Abnormalities

Time frame:Baseline up to 14 days after last dose (Day 70)

event count, event

Posted result

Group	Participants	95% CI
PlaceboHematology - Neutrophils (10^3/mm3) >1.2xupper limit of norma (ULN)	0	-
Hematology - Basophils (10^3/mm3) >1.2xULN	0	-
Chemistry - Urate (mg/dL) >1.2xULN	0	-
Chemistry - high-density lipoprotein cholesterol (mg/dL) <0.8xlower limit of normal (LLN)	2	-
Chemistry - Triglycerides (mg/dL) >1.3xULN	0	-
Chemistry - Thyrotropin (uIU/mL) <0.8xLLN	0	-
Chemistry - Bile Acid (umol/L) >1.0xULN	0	-
Urinalysis - Urine Glucose ≥1	3	-
Urinalysis - Urine Ketones (Scalar) ≥1	0	-
Urinalysis - Urine Protein ≥1	0	-
Urinalysis - Urine Hemoglobin (Scalar) ≥1	1	-
Urinalysis - Urine Urobilinogen ≥1	0	-
Urinalysis - Urine Nitrite (Scalar) ≥1	0	-
Urinalysis - Urine Leukocyte Esterase (Scalar) ≥1	0	-
PF-06882961 BIDHematology - Neutrophils (10^3/mm3) >1.2xupper limit of norma (ULN)	1	-
Hematology - Basophils (10^3/mm3) >1.2xULN	1	-
Chemistry - Urate (mg/dL) >1.2xULN	4	-
Chemistry - high-density lipoprotein cholesterol (mg/dL) <0.8xlower limit of normal (LLN)	1	-
Chemistry - Triglycerides (mg/dL) >1.3xULN	3	-
Chemistry - Thyrotropin (uIU/mL) <0.8xLLN	1	-
Chemistry - Bile Acid (umol/L) >1.0xULN	1	-
Urinalysis - Urine Glucose ≥1	6	-
Urinalysis - Urine Ketones (Scalar) ≥1	2	-
Urinalysis - Urine Protein ≥1	1	-
Urinalysis - Urine Hemoglobin (Scalar) ≥1	3	-
Urinalysis - Urine Urobilinogen ≥1	2	-
Urinalysis - Urine Nitrite (Scalar) ≥1	1	-
Urinalysis - Urine Leukocyte Esterase (Scalar) ≥1	2	-

Secondary/protocol endpoint

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

Time frame:Baseline up to 14 days after last dose (Day 70)

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Abnormal Electrocardiogram (ECG)

Time frame:Baseline up to 14 days after last dose (Day 70)

descriptive

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

Time frame:Baseline up to 35 days after last dose (Day 91)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Laboratory Abnormalities

Time frame:Baseline up to 14 days after last dose (Day 70)

event count, event

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.