CompletedPhase 2Results posted

A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus

A 16-WEEK, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TWICE DAILY PF-06882961 ADMINISTRATION IN ADULTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED ON METFORMIN OR DIET AND EXERCISE

Lead sponsor

Pfizer

Asset

Danuglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

412

Study population

Type 2 diabetes

Eligibility highlights

•BMI 24.5-45.4•HbA1c ≥7%

Primary endpoint

•HbA1c, 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 IDNCT03985293

Org study IDC3421005

Secondary ID2019-000218-12

Timeline

Milestones

Study first posted2019-06-13actual

Study start2019-10-15actual

Primary completion2021-06-08actual

Study completion2021-07-07actual

Last update posted2022-06-30actual

Results first posted2022-06-30actual

Assets

Investigational agents

Danuglipron

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with T2DM who are treated with metformin and/or 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 24.5 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 medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis

•Known history of HIV

•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 (23)

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.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Weight & body composition

6 endpoints

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 2

Time frame:Baseline, Week 2

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · Kilogram	95% CI
Placebo	-0.15	-0.47 - 0.17
PF-06882961 2.5 BID	-0.09	-0.41 - 0.23
PF-06882961 10 mg BID	-0.12	-0.44 - 0.19
PF-06882961 40 mg BID	-0.23	-0.54 - 0.08
PF-06882961 80 mg BID	-0.57	-0.89 - -0.24
PF-06882961 120 mg BID	-0.54	-0.85 - -0.24

Difference in ls mean0.0690% CI-0.33 - 0.44p0.8011Mixed Models Analysis

Difference in ls mean0.0290% CI-0.35 - 0.40p0.9149Mixed Models Analysis

Difference in ls mean-0.0890% CI-0.46 - 0.30p0.7216Mixed Models Analysis

Difference in ls mean-0.4290% CI-0.80 - -0.03p0.0758Mixed Models Analysis

Difference in ls mean-0.4090% CI-0.77 - -0.02p0.0860Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 4

Time frame:Baseline, Week 4

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · Kilogram	95% CI
Placebo	-0.25	-0.64 - 0.15
PF-06882961 2.5 BID	-0.33	-0.72 - 0.07
PF-06882961 10 mg BID	-0.08	-0.46 - 0.30
PF-06882961 40 mg BID	-0.77	-1.15 - -0.39
PF-06882961 80 mg BID	-1.05	-1.45 - -0.64
PF-06882961 120 mg BID	-1.33	-1.71 - -0.95

Difference in ls mean-0.0890% CI-0.59 - 0.42p0.7898Mixed Models Analysis

Difference in ls mean0.1690% CI-0.33 - 0.66p0.5829Mixed Models Analysis

Difference in ls mean-0.5290% CI-1.02 - -0.03p0.0827Mixed Models Analysis

Difference in ls mean-0.8090% CI-1.31 - -0.29p0.0101Mixed Models Analysis

Difference in ls mean-1.0990% CI-1.59 - -0.59p0.0004Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 6

Time frame:Baseline, Week 6

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · Kilogram	95% CI
Placebo	-0.09	-0.57 - 0.40
PF-06882961 2.5 BID	-0.19	-0.68 - 0.31
PF-06882961 10 mg BID	-0.32	-0.78 - 0.15
PF-06882961 40 mg BID	-0.83	-1.31 - -0.36
PF-06882961 80 mg BID	-1.69	-2.20 - -1.19
PF-06882961 120 mg BID	-2.34	-2.83 - -1.85

Difference in ls mean-0.1090% CI-0.75 - 0.55p0.7985Mixed Models Analysis

Difference in ls mean-0.2390% CI-0.86 - 0.40p0.5484Mixed Models Analysis

Difference in ls mean-0.7590% CI-1.38 - -0.11p0.0541Mixed Models Analysis

Difference in ls mean-1.6090% CI-2.26 - -0.95p<.0001Mixed Models Analysis

Difference in ls mean-2.2590% CI-2.90 - -1.60p<.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 8

Time frame:Baseline, Week 8

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · Kilogram	95% CI
Placebo	-0.36	-0.89 - 0.16
PF-06882961 2.5 BID	-0.05	-0.59 - 0.49
PF-06882961 10 mg BID	-0.27	-0.78 - 0.23
PF-06882961 40 mg BID	-1.09	-1.60 - -0.57
PF-06882961 80 mg BID	-1.97	-2.52 - -1.42
PF-06882961 120 mg BID	-3.31	-3.85 - -2.77

Difference in ls mean0.3190% CI-0.40 - 1.03p0.4692Mixed Models Analysis

Difference in ls mean0.0990% CI-0.60 - 0.78p0.8274Mixed Models Analysis

Difference in ls mean-0.7290% CI-1.42 - -0.02p0.0887Mixed Models Analysis

Difference in ls mean-1.6190% CI-2.33 - -0.88p0.0003Mixed Models Analysis

Difference in ls mean-2.9590% CI-3.67 - -2.22p<.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 12

Time frame:Baseline, Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · Kilogram	95% CI
Placebo	-0.24	-0.85 - 0.38
PF-06882961 2.5 BID	-0.09	-0.72 - 0.53
PF-06882961 10 mg BID	-0.00	-0.59 - 0.58
PF-06882961 40 mg BID	-1.05	-1.65 - -0.44
PF-06882961 80 mg BID	-2.52	-3.17 - -1.87
PF-06882961 120 mg BID	-3.81	-4.46 - -3.16

Difference in ls mean0.1590% CI-0.70 - 0.99p0.7758Mixed Models Analysis

Difference in ls mean0.2390% CI-0.58 - 1.05p0.6367Mixed Models Analysis

Difference in ls mean-0.8190% CI-1.63 - 0.02p0.1082Mixed Models Analysis

Difference in ls mean-2.2890% CI-3.14 - -1.42p<.0001Mixed Models Analysis

Difference in ls mean-3.5790% CI-4.44 - -2.70p<.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 16

Time frame:Baseline, Week 16

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · Kilogram	95% CI
Placebo	-0.43	-1.12 - 0.25
PF-06882961 2.5 BID	0.02	-0.68 - 0.72
PF-06882961 10 mg BID	-0.06	-0.71 - 0.60
PF-06882961 40 mg BID	-1.16	-1.84 - -0.49
PF-06882961 80 mg BID	-2.48	-3.20 - -1.75
PF-06882961 120 mg BID	-4.60	-5.34 - -3.86

Difference in ls mean0.4590% CI-0.50 - 1.41p0.4325Mixed Models Analysis

Difference in ls mean0.3890% CI-0.54 - 1.30p0.4978Mixed Models Analysis

Difference in ls mean-0.7390% CI-1.66 - 0.20p0.1970Mixed Models Analysis

Difference in ls mean-2.0490% CI-3.01 - -1.07p0.0006Mixed Models Analysis

Difference in ls mean-4.1790% CI-5.15 - -3.18p<.0001Mixed Models Analysis

Glycemic / diabetes

13 endpoints

Primary/protocol endpoint

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16

Time frame:Baseline, Week 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percent	95% CI
Placebo	-0.02	-0.22 - 0.19
PF-06882961 2.5 BID	-0.49	-0.70 - -0.28
PF-06882961 10 mg BID	-0.91	-1.11 - -0.72
PF-06882961 40 mg BID	-1.03	-1.23 - -0.83
PF-06882961 80 mg BID	-0.96	-1.18 - -0.74
PF-06882961 120 mg BID	-1.18	-1.41 - -0.95

Difference in ls mean-0.4790% CI-0.76 - -0.18p0.0071Mixed Models Analysis

Difference in ls mean-0.9090% CI-1.18 - -0.62p<.0001Mixed Models Analysis

Difference in ls mean-1.0190% CI-1.30 - -0.73p<.0001Mixed Models Analysis

Difference in ls mean-0.9490% CI-1.24 - -0.65p<.0001Mixed Models Analysis

Difference in ls mean-1.1690% CI-1.47 - -0.86p<.0001Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels

Time frame:Baseline, Week 16

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Number · Percentage of Participants	95% CI
Placebo	7.7	-
PF-06882961 2.5 BID	30.8	-
PF-06882961 10 mg BID	54.1	-
PF-06882961 40 mg BID	58.2	-
PF-06882961 80 mg BID	65.2	-
PF-06882961 120 mg BID	60.5	-

Odds ratio (or)5.1190% CI1.84 - 14.18Regression, Logistic

Odds ratio (or)16.8590% CI6.18 - 45.93Regression, Logistic

Odds ratio (or)18.7990% CI7.03 - 50.21Regression, Logistic

Odds ratio (or)23.9790% CI8.66 - 66.39Regression, Logistic

Odds ratio (or)24.4690% CI8.72 - 68.57Regression, Logistic

Secondary/protocol endpoint

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2

Time frame:Baseline, Week 2

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percent	95% CI
Placebo	-0.09	-0.17 - -0.01
PF-06882961 2.5 BID	-0.18	-0.26 - -0.09
PF-06882961 10 mg BID	-0.31	-0.39 - -0.23
PF-06882961 40 mg BID	-0.29	-0.37 - -0.21
PF-06882961 80 mg BID	-0.33	-0.41 - -0.24
PF-06882961 120 mg BID	-0.35	-0.43 - -0.28

Difference in ls mean-0.0990% CI-0.19 - 0.01p0.1578Mixed Models Analysis

Difference in ls mean-0.2290% CI-0.32 - -0.12p0.0003Mixed Models Analysis

Difference in ls mean-0.2090% CI-0.30 - -0.10p0.0013Mixed Models Analysis

Difference in ls mean-0.2490% CI-0.34 - -0.14p0.0001Mixed Models Analysis

Difference in ls mean-0.2690% CI-0.36 - -0.16p<.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4

Time frame:Baseline, Week 4

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percent	95% CI
Placebo	-0.08	-0.19 - 0.04
PF-06882961 2.5 BID	-0.38	-0.50 - -0.26
PF-06882961 10 mg BID	-0.51	-0.62 - -0.39
PF-06882961 40 mg BID	-0.63	-0.74 - -0.52
PF-06882961 80 mg BID	-0.58	-0.70 - -0.46
PF-06882961 120 mg BID	-0.64	-0.75 - -0.53

Difference in ls mean-0.3090% CI-0.46 - -0.15p0.0013Mixed Models Analysis

Difference in ls mean-0.4390% CI-0.58 - -0.28p<.0001Mixed Models Analysis

Difference in ls mean-0.5590% CI-0.70 - -0.40p<.0001Mixed Models Analysis

Difference in ls mean-0.5090% CI-0.66 - -0.35p<.0001Mixed Models Analysis

Difference in ls mean-0.5690% CI-0.71 - -0.41p<.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6

Time frame:Baseline, Week 6

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percent	95% CI
Placebo	-0.07	-0.21 - 0.07
PF-06882961 2.5 BID	-0.47	-0.61 - -0.34
PF-06882961 10 mg BID	-0.71	-0.84 - -0.57
PF-06882961 40 mg BID	-0.84	-0.97 - -0.71
PF-06882961 80 mg BID	-0.79	-0.93 - -0.65
PF-06882961 120 mg BID	-0.84	-0.98 - -0.71

Difference in ls mean-0.4090% CI-0.59 - -0.22p0.0004Mixed Models Analysis

Difference in ls mean-0.6490% CI-0.81 - -0.46p<.0001Mixed Models Analysis

Difference in ls mean-0.7790% CI-0.95 - -0.59p<.0001Mixed Models Analysis

Difference in ls mean-0.7290% CI-0.91 - -0.53p<.0001Mixed Models Analysis

Difference in ls mean-0.7790% CI-0.95 - -0.59p<.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8

Time frame:Baseline, Week 8

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percent	95% CI
Placebo	-0.13	-0.29 - 0.03
PF-06882961 2.5 BID	-0.50	-0.66 - -0.34
PF-06882961 10 mg BID	-0.78	-0.93 - -0.62
PF-06882961 40 mg BID	-0.97	-1.13 - -0.82
PF-06882961 80 mg BID	-0.92	-1.09 - -0.76
PF-06882961 120 mg BID	-1.02	-1.18 - -0.86

Difference in ls mean-0.3790% CI-0.59 - -0.15p0.0054Mixed Models Analysis

Difference in ls mean-0.6590% CI-0.86 - -0.44p<.0001Mixed Models Analysis

Difference in ls mean-0.8490% CI-1.06 - -0.63p<.0001Mixed Models Analysis

Difference in ls mean-0.8090% CI-1.02 - -0.57p<.0001Mixed Models Analysis

Difference in ls mean-0.8990% CI-1.11 - -0.67p<.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12

Time frame:Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percent	95% CI
Placebo	-0.09	-0.28 - 0.10
PF-06882961 2.5 BID	-0.53	-0.72 - -0.34
PF-06882961 10 mg BID	-0.88	-1.06 - -0.70
PF-06882961 40 mg BID	-1.06	-1.25 - -0.88
PF-06882961 80 mg BID	-0.91	-1.12 - -0.71
PF-06882961 120 mg BID	-1.11	-1.32 - -0.91

Difference in ls mean-0.4490% CI-0.71 - -0.18p0.0061Mixed Models Analysis

Difference in ls mean-0.7990% CI-1.05 - -0.54p<.0001Mixed Models Analysis

Difference in ls mean-0.9890% CI-1.24 - -0.72p<.0001Mixed Models Analysis

Difference in ls mean-0.8390% CI-1.10 - -0.56p<.0001Mixed Models Analysis

Difference in ls mean-1.0390% CI-1.30 - -0.75p<.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose at Week 2

Time frame:Baseline, Week 2

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · mg/dL	95% CI
Placebo	-5.58	-12.66 - 1.49
PF-06882961 2.5 BID	-22.72	-29.78 - -15.65
PF-06882961 10 mg BID	-21.96	-28.91 - -15.01
PF-06882961 40 mg BID	-27.79	-34.60 - -20.98
PF-06882961 80 mg BID	-24.18	-31.28 - -17.08
PF-06882961 120 mg BID	-30.92	-37.66 - -24.17

Difference in ls mean-17.1390% CI-25.94 - -8.33p0.0014Mixed Models Analysis

Difference in ls mean-16.3890% CI-25.08 - -7.67p0.0021Mixed Models Analysis

Difference in ls mean-22.2090% CI-30.88 - -13.53p<.0001Mixed Models Analysis

Difference in ls mean-18.5990% CI-27.43 - -9.76p0.0006Mixed Models Analysis

Difference in ls mean-25.3390% CI-34.00 - -16.67p<.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose at Week 4

Time frame:Baseline, Week 4

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · mg/dL	95% CI
Placebo	-5.98	-13.62 - 1.66
PF-06882961 2.5 BID	-17.77	-25.46 - -10.09
PF-06882961 10 mg BID	-24.66	-31.98 - -17.35
PF-06882961 40 mg BID	-33.42	-40.83 - -26.00
PF-06882961 80 mg BID	-33.34	-41.25 - -25.44
PF-06882961 120 mg BID	-34.06	-41.52 - -26.60

Difference in ls mean-11.7990% CI-21.55 - -2.04p0.0468Mixed Models Analysis

Difference in ls mean-18.6890% CI-28.12 - -9.25p0.0012Mixed Models Analysis

Difference in ls mean-27.4490% CI-37.03 - -17.85p<.0001Mixed Models Analysis

Difference in ls mean-27.3690% CI-37.22 - -17.51p<.0001Mixed Models Analysis

Difference in ls mean-28.0990% CI-37.72 - -18.45p<.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose at Week 6

Time frame:Baseline, Week 6

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · mg/dL	95% CI
Placebo	-0.88	-8.62 - 6.86
PF-06882961 2.5 BID	-16.78	-24.67 - -8.89
PF-06882961 10 mg BID	-26.41	-33.88 - -18.94
PF-06882961 40 mg BID	-30.89	-38.47 - -23.30
PF-06882961 80 mg BID	-28.36	-36.51 - -20.21
PF-06882961 120 mg BID	-32.65	-40.44 - -24.87

Difference in ls mean-15.9090% CI-25.90 - -5.90p0.0091Mixed Models Analysis

Difference in ls mean-25.5390% CI-35.18 - -15.89p<.0001Mixed Models Analysis

Difference in ls mean-30.0190% CI-39.80 - -20.21p<.0001Mixed Models Analysis

Difference in ls mean-27.4890% CI-37.63 - -17.33p<.0001Mixed Models Analysis

Difference in ls mean-31.7790% CI-41.77 - -21.78p<.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose at Week 8

Time frame:Baseline, Week 8

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · mg/dL	95% CI
Placebo	-9.10	-16.80 - -1.41
PF-06882961 2.5 BID	-12.73	-20.53 - -4.93
PF-06882961 10 mg BID	-26.23	-33.57 - -18.89
PF-06882961 40 mg BID	-29.74	-37.26 - -22.23
PF-06882961 80 mg BID	-33.22	-41.36 - -25.09
PF-06882961 120 mg BID	-34.31	-42.46 - -26.16

Difference in ls mean-3.6390% CI-13.51 - 6.25p0.5449Mixed Models Analysis

Difference in ls mean-17.1290% CI-26.62 - -7.63p0.0031Mixed Models Analysis

Difference in ls mean-20.6490% CI-30.31 - -10.96p0.0005Mixed Models Analysis

Difference in ls mean-24.1290% CI-34.20 - -14.04p<.0001Mixed Models Analysis

Difference in ls mean-25.2190% CI-35.44 - -14.97p<.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose at Week 12

Time frame:Baseline, Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · mg/dL	95% CI
Placebo	1.21	-7.93 - 10.35
PF-06882961 2.5 BID	-6.49	-15.70 - 2.73
PF-06882961 10 mg BID	-22.56	-31.17 - -13.95
PF-06882961 40 mg BID	-32.01	-40.89 - -23.14
PF-06882961 80 mg BID	-30.45	-40.26 - -20.64
PF-06882961 120 mg BID	-32.38	-42.83 - -21.94

Difference in ls mean-7.7090% CI-19.78 - 4.38p0.2940Mixed Models Analysis

Difference in ls mean-23.7790% CI-35.37 - -12.17p0.0008Mixed Models Analysis

Difference in ls mean-33.2390% CI-45.05 - -21.40p<.0001Mixed Models Analysis

Difference in ls mean-31.6690% CI-44.14 - -19.19p<.0001Mixed Models Analysis

Difference in ls mean-33.5990% CI-46.67 - -20.51p<.0001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose at Week 16

Time frame:Baseline, Week 16

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · mg/dL	95% CI
Placebo	1.31	-7.58 - 10.20
PF-06882961 2.5 BID	-12.81	-21.71 - -3.91
PF-06882961 10 mg BID	-24.53	-32.88 - -16.18
PF-06882961 40 mg BID	-30.47	-39.06 - -21.87
PF-06882961 80 mg BID	-25.71	-35.15 - -16.26
PF-06882961 120 mg BID	-31.93	-41.73 - -22.13

Difference in ls mean-14.1290% CI-25.77 - -2.47p0.0464Mixed Models Analysis

Difference in ls mean-25.8490% CI-37.05 - -14.62p0.0002Mixed Models Analysis

Difference in ls mean-31.7890% CI-43.20 - -20.35p<.0001Mixed Models Analysis

Difference in ls mean-27.0290% CI-39.03 - -15.01p0.0002Mixed Models Analysis

Difference in ls mean-33.2490% CI-45.63 - -20.84p<.0001Mixed Models Analysis

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline up to Week 21

Treatment-emergent AEs (any)

event count, event

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

Posted result

Group	Participants	95% CI
PlaceboNumber of Participants With Treatment Emergent AEs	32	-
Number of Participants With Treatment Emergent SAEs	1	-
PF-06882961 2.5 BIDNumber of Participants With Treatment Emergent AEs	32	-
Number of Participants With Treatment Emergent SAEs	1	-
PF-06882961 10 mg BIDNumber of Participants With Treatment Emergent AEs	31	-
Number of Participants With Treatment Emergent SAEs	2	-
PF-06882961 40 mg BIDNumber of Participants With Treatment Emergent AEs	42	-
Number of Participants With Treatment Emergent SAEs	6	-
PF-06882961 80 mg BIDNumber of Participants With Treatment Emergent AEs	43	-
Number of Participants With Treatment Emergent SAEs	2	-
PF-06882961 120 mg BIDNumber of Participants With Treatment Emergent AEs	44	-
Number of Participants With Treatment Emergent SAEs	1	-

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality

Time frame:Baseline Through Week 21

event count, event

Posted result

Group	Participants	95% CI
Placebo	60	-
PF-06882961 2.5 BID	57	-
PF-06882961 10 mg BID	57	-
PF-06882961 40 mg BID	57	-
PF-06882961 80 mg BID	60	-
PF-06882961 120 mg BID	64	-

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Vital Signs Abnormalities

Time frame:Baseline through Week 21

threshold achievement, event

Posted result

Group	Participants	95% CI
PlaceboSupine SBP <90 mmHg	0	-
Supine SBP increase >=30 mmHg	3	-
Supine SBP decrease >=30 mmHg	4	-
Supine DBP <50 mmHg	1	-
Supine DBP increase >=20 mmHg	1	-
Supine DBP decrease >=20 mmHg	3	-
Supine pulse rate <40 bpm	0	-
Supine pulse rate >120 bpm	0	-
PF-06882961 2.5 BIDSupine SBP <90 mmHg	0	-
Supine SBP increase >=30 mmHg	4	-
Supine SBP decrease >=30 mmHg	4	-
Supine DBP <50 mmHg	0	-
Supine DBP increase >=20 mmHg	1	-
Supine DBP decrease >=20 mmHg	4	-
Supine pulse rate <40 bpm	0	-
Supine pulse rate >120 bpm	0	-
PF-06882961 10 mg BIDSupine SBP <90 mmHg	0	-
Supine SBP increase >=30 mmHg	3	-
Supine SBP decrease >=30 mmHg	3	-
Supine DBP <50 mmHg	0	-
Supine DBP increase >=20 mmHg	2	-
Supine DBP decrease >=20 mmHg	1	-
Supine pulse rate <40 bpm	0	-
Supine pulse rate >120 bpm	0	-
PF-06882961 40 mg BIDSupine SBP <90 mmHg	0	-
Supine SBP increase >=30 mmHg	3	-
Supine SBP decrease >=30 mmHg	5	-
Supine DBP <50 mmHg	1	-
Supine DBP increase >=20 mmHg	3	-
Supine DBP decrease >=20 mmHg	3	-
Supine pulse rate <40 bpm	0	-
Supine pulse rate >120 bpm	0	-
PF-06882961 80 mg BIDSupine SBP <90 mmHg	0	-
Supine SBP increase >=30 mmHg	0	-
Supine SBP decrease >=30 mmHg	5	-
Supine DBP <50 mmHg	0	-
Supine DBP increase >=20 mmHg	3	-
Supine DBP decrease >=20 mmHg	2	-
Supine pulse rate <40 bpm	0	-
Supine pulse rate >120 bpm	0	-
PF-06882961 120 mg BIDSupine SBP <90 mmHg	0	-
Supine SBP increase >=30 mmHg	5	-
Supine SBP decrease >=30 mmHg	0	-
Supine DBP <50 mmHg	1	-
Supine DBP increase >=20 mmHg	3	-
Supine DBP decrease >=20 mmHg	1	-
Supine pulse rate <40 bpm	0	-
Supine pulse rate >120 bpm	0	-

Secondary/protocol endpoint

Number of Participants With Treatment Emergent ECG Abnormalities

Time frame:Baseline Through Week 21

threshold achievement, event

Posted result

Group	Participants	95% CI
PlaceboPR interval ≥300 msec	0	-
%Change in PR interval ≥25/50%	3	-
QRS interval ≥140 msec	1	-
%Change in QRS interval ≥50%	1	-
QTcF interval >450 and ≤480 msec	2	-
QTcF interval >480 and ≤500 msec	0	-
QTcF interval >500 msec	0	-
Change in QTcF interval >30 and ≤60 msec	2	-
Change in QTcF interval >60 msec	0	-
PF-06882961 2.5 BIDPR interval ≥300 msec	0	-
%Change in PR interval ≥25/50%	0	-
QRS interval ≥140 msec	1	-
%Change in QRS interval ≥50%	1	-
QTcF interval >450 and ≤480 msec	3	-
QTcF interval >480 and ≤500 msec	0	-
QTcF interval >500 msec	0	-
Change in QTcF interval >30 and ≤60 msec	3	-
Change in QTcF interval >60 msec	0	-
PF-06882961 10 mg BIDPR interval ≥300 msec	0	-
%Change in PR interval ≥25/50%	0	-
QRS interval ≥140 msec	0	-
%Change in QRS interval ≥50%	0	-
QTcF interval >450 and ≤480 msec	2	-
QTcF interval >480 and ≤500 msec	0	-
QTcF interval >500 msec	0	-
Change in QTcF interval >30 and ≤60 msec	2	-
Change in QTcF interval >60 msec	1	-
PF-06882961 40 mg BIDPR interval ≥300 msec	0	-
%Change in PR interval ≥25/50%	0	-
QRS interval ≥140 msec	0	-
%Change in QRS interval ≥50%	0	-
QTcF interval >450 and ≤480 msec	1	-
QTcF interval >480 and ≤500 msec	0	-
QTcF interval >500 msec	0	-
Change in QTcF interval >30 and ≤60 msec	6	-
Change in QTcF interval >60 msec	1	-
PF-06882961 80 mg BIDPR interval ≥300 msec	0	-
%Change in PR interval ≥25/50%	1	-
QRS interval ≥140 msec	0	-
%Change in QRS interval ≥50%	0	-
QTcF interval >450 and ≤480 msec	3	-
QTcF interval >480 and ≤500 msec	0	-
QTcF interval >500 msec	0	-
Change in QTcF interval >30 and ≤60 msec	3	-
Change in QTcF interval >60 msec	0	-
PF-06882961 120 mg BIDPR interval ≥300 msec	1	-
%Change in PR interval ≥25/50%	0	-
QRS interval ≥140 msec	0	-
%Change in QRS interval ≥50%	0	-
QTcF interval >450 and ≤480 msec	4	-
QTcF interval >480 and ≤500 msec	1	-
QTcF interval >500 msec	0	-
Change in QTcF interval >30 and ≤60 msec	6	-
Change in QTcF interval >60 msec	3	-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron for Glycemic Control Among Patients With Type 2 Diabetes: A Randomized Clinical Trial.
JAMA network open2023 May 1PMID37213102doi:10.1001/jamanetworkopen.2023.14493via clinicaltrials gov reference derived + pubmed nct search

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.