GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

STUDY OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT AND PARTICIPANTS WITHOUT RENAL IMPAIRMENT

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT RENAL IMPAIRMENT

Lead sponsor

Pfizer

Asset

Danuglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Renal impairment, Type 2 diabetes

Key I/E criteria

•BMI 18-45.4•HbA1c 6-10.5%•Healthy volunteers

Primary endpoints

•Cmax of Plasma PF-06882961•Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated•Area Under the Plasma Concentration-Time Profile

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04616027

Org study IDC3421012

Timeline

Milestones

Study first posted2020-11-04actual

Study start2021-01-13actual

Primary completion2022-02-18actual

Study completion2022-02-18actual

Last update posted2024-05-10actual

Results first posted2024-05-10actual

Assets

Investigational agents

Danuglipron

Study populations

Who this study enrolls

Healthy volunteersRenal impairmentType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Stable renal function (for participants not on dialysis) defined as ≤25% difference between 2 measurements of eGFR (as calculated by the sponsor-identified central laboratory using the CKD-EPI equation)1 obtained at Screening visits S1 and S2. The average of the 2 eGFR values obtained from S1 and S2 will be used for study enrollment and assignment to appropriate renal function group. Note: participants on dialysis will be placed in Group 5 regardless of eGFR from S1 and S2 (S2 is optional for dialysis participants only).

•Male and female participants must be ≥18 years of age, inclusive, at the time of signing the informed consent document (ICD).

•Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including the ability to perform self-monitoring blood glucose at a frequency deemed appropriate by the investigator.

•Body mass index (BMI) of ≥18.0 kg/m2 and <45.4 kg/m2; and a total body weight >50 kg (110 lb).

•Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Additional Inclusion Criteria for Healthy Participants with Normal Renal

Function (Group 1):

•No clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, standard 12-lead ECG and clinical laboratory tests.

•Normal renal function (mean eGFR ≥90 mL/min) based on an average of measures from Screening visits S1 and S2.

•Demographically comparable to participants with impaired renal function:

1. A body weight within ±15 kg of the mean body weight of the pooled renal impairment groups (Groups 3, 4, and 5), as provided by sponsor;

2. An age within ±10 years of the mean age of the pooled renal impairment groups (Groups 3, 4 and 5), as provided by sponsor;

3. Attempts will be made to ensure that the male to female distribution in Group 1 is comparable to that in the pooled renal impairment groups (Cohorts 3, 4, and 5).

Additional Inclusion Criteria for T2DM Participants with Normal Renal

Function (Group 2):

•A prior diagnosis of T2DM with an HbA1c ≥6% and ≤10.5%, at Screening visit S1, confirmed by a single repeat, if deemed necessary.

•Normal renal function (mean eGFR ≥90 mL/min) based on an average of measures from Screening visits S1 and S2.

•Prohibited prior/concomitant medications.

•Demographically comparable to participants with impaired renal function:

1. A body weight within ±15 kg of the mean body weight of the pooled renal impairment groups (Groups 3, 4, and 5), as provided by sponsor;

2. An age within ±10 years of the mean age of the pooled renal impairment groups (Groups 3, 4, and 5), as provided by sponsor;

3. Attempts will be made to ensure that the male to female distribution in Group 2 is comparable to that in the pooled renal impairment groups (Cohorts 3, 4, and 5).

Additional Inclusion Criteria for T2DM Participants with Impaired Renal Function (Groups 3-5):

•A prior diagnosis of T2DM with an HbA1c ≥6% and ≤10.5%, at Screening visit S1, confirmed by a single repeat, if deemed necessary.

•Meet the eGFR criteria listed for Groups 3, 4, or 5 (for participants not on dialysis) in Table 1 based on an average of measures from Screening visits S1 and S2.

•Stable concomitant medications, as defined in Section 6.5, for the management of medical conditions relevant to an individual participant's medical history. Participants receiving fluctuating concomitant medications/treatments may be considered, on a case-by-case basis with input from sponsor, if the underlying disease is stable.

•For Group 5 participants on dialysis only, participants must have required hemodialysis for at least 6 weeks and need dialysis sessions 3 times per week

Exclusion criteria

•Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

•Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency). NOTE: subjects who have undergone cholecystectomy and/or appendectomy are eligible for this study so long as the surgery occurred more than 6 months prior to Screening;

•Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin); a participant is considered cured if there has been no evidence of cancer recurrence in the previous 5 years.

•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator's judgement.

•History of chronic or acute pancreatitis within 5 years.

•Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes.

•History of diabetic ketoacidosis.

•History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II-IV heart failure, or transient ischemic attack within 3 months of Screening visit S1.

•Urinary incontinence.

•Participants with acute renal disease.

•Renal allograft recipients.

•Participants with other clinically significant disease, in the judgment of the investigator that may affect the safety of the participant or that may affect the PK of PF 06882961.

•Prohibited prior/concomitant medications.

•Compliance with details regarding prohibited prior/concomitant medications.

•Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of IP used in this study (whichever is longer).

•Known prior participation in a trial involving PF 06882961 or known hypersensitivity or intolerance to a GLP-1R agonist.

•Screening standard 12-lead ECG that demonstrates a clinically relevant abnormality that requires further diagnostic evaluation or intervention (eg, new, clinically relevant arrhythmia, conduction disturbance, findings suggestive of ischemia). A potential participant whose pre-dose ECG (on Day 1, 0 hour) demonstrates a clinically relevant abnormality that requires further diagnostic evaluation or intervention will be considered a screen failure.

•A positive COVID-19 test in the screening period.

•A positive urine drug test (or other type of drug test in anuric participants on dialysis only).

•Participants with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study specific central laboratory and confirmed by a single repeat test, if deemed necessary:

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥2 × upper limit of normal (ULN);

–Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.

–Fasting C-peptide <0.8 ng/mL.

–Fasting plasma glucose (FPG) >270 mg/dL (15 mmol/L) at screening (S1).

•History of regular alcohol consumption exceeding 7 drinks/week for female participants or 14 drinks/week for male participants (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.

•Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.

•History of sensitivity to heparin or heparin-induced thrombocytopenia only if heparin is planned to flush intravenous catheters.

Additional Exclusion Criteria for Healthy Participants with Normal Renal

Function (Group 1):

- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically relevant and significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

•Use of prescription or non-prescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of IP). As an exception, ibuprofen or acetaminophen may be used at doses of ≤1 g/day. Limited use of non-prescription medications that are not believed to affect participant safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

•Screening seated systolic blood pressure (SBP) >140 mmHg or diastolic blood pressure (DBP) >90 mmHg, following at least 5 minutes of supine rest. If SBP is >140 mmHg or DBP >90 mmHg, the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.

HbA1c ≥6.0% at Screening visit S1; FPG ≥126 mg/dL at screening (S1); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.5 × upper limit of normal (ULN). Additional Exclusion Criteria for T2DM Participants with Normal Renal

Function (Group 2):

- At Screening, seated systolic blood pressure (SBP) ≥160 mm Hg and/or diastolic blood pressure (DBP) ≥105 mm Hg after ≥5minute of seated rest, with a single repeat permitted to assess eligibility, if needed, at each of these 2 visits.

Additional Exclusion Criteria for T2DM Participants with Impaired Renal

Function (Groups 3-5) only:

- At Screening, persistent severe, uncontrolled hypertension; for example: seated systolic blood pressure (SBP) ≥180 mm Hg and/or diastolic blood pressure (DBP) ≥105 mm Hg after ≥5minute of seated rest, with a single repeat permitted to assess eligibility, if needed, at each of these 2 visits: For subjects with SBP ≥160 mm Hg or DBP ≥100 mm Hg, the period between Screening and Day 1 must be used to refine the doses of the agents used for management of blood pressure with the aim to have stable BP on Day 1;.

- For participants in Group 5 on Dialysis only: Hemodynamic instability during or at the conclusion of dialysis during the 2 weeks prior to dosing, as marked by symptomatic hypotension.

Criteria for Dosing on Day 1

Participants will progress to dosing on Day 1 provided they have satisfied all the following criteria:

•In women of childbearing potential, urine pregnancy test on Day -1 is negative;

•Cohort 1 and Cohort 2 only: Approval from the sponsor must be obtained before proceeding with dosing participants in either Cohort 1 or Cohort 2;

•Cohorts 2-5 only: Participants must have measurement on Day 1 of SBP <160 mm Hg and DBP <100 mm Hg; A single repeat assessment is permitted, to confirm that the above criterion is met [and in such cases, the repeat assessment overrides initial results].

Endpoints (34)

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

34 endpoints

Primary/registry result

Maximum Observed Plasma Concentration (Cmax) of Plasma PF-06882961

Time frame:0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanograms/milliliter (ng/mL)	95% CI
Healthy and Normal Renal Function	38.80	—
T2DM Normal Renal Function	38.67	—
T2DM Mild Renal Impairment	39.19	—
T2DM Moderate Renal Impairment	56.68	—
T2DM Severe Renal Impairment	39.18	—

Ratio (Test/Reference) of Adjusted Means99.6790% CI70.15 – 141.60

"T2DM Normal Renal Function" was test, "Healthy and Normal Renal Function" was reference.

Ratio (Test/Reference) of Adjusted Means101.3490% CI70.51 – 145.63

"T2DM Mild Renal Impairment" was test, "T2DM Normal Renal Function" was reference.

Ratio (Test/Reference) of Adjusted Means146.5690% CI103.16 – 208.22

"T2DM Moderate Renal Impairment" was test, "T2DM Normal Renal Function" was reference.

Ratio (Test/Reference) of Adjusted Means101.3190% CI71.31 – 143.92

"T2DM Severe Renal Impairment" was test, "T2DM Normal Renal Function" was reference.

Primary/registry result

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Plasma PF-06882961

Time frame:0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramshour/milliliter (nghr/mL)	95% CI
Healthy and Normal Renal Function	362.4	—
T2DM Normal Renal Function	404.8	—
T2DM Mild Renal Impairment	487.0	—
T2DM Moderate Renal Impairment	543.2	—
T2DM Severe Renal Impairment	408.8	—

Ratio (Test/Reference) of Adjusted Means111.7190% CI79.52 – 156.93

"T2DM Normal Renal Function" was test, "Healthy and Normal Renal Function" was reference.

Ratio (Test/Reference) of Adjusted Means120.3190% CI83.49 – 173.38

"T2DM Mild Renal Impairment" was test, "T2DM Normal Renal Function" was reference.

Ratio (Test/Reference) of Adjusted Means134.1890% CI94.46 – 190.62

"T2DM Moderate Renal Impairment" was test, "T2DM Normal Renal Function" was reference.

Ratio (Test/Reference) of Adjusted Means100.9990% CI71.89 – 141.87

"T2DM Severe Renal Impairment" was test, "T2DM Normal Renal Function" was reference.

Primary/registry result

Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of Plasma PF-06882961

Time frame:0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng*hr/mL	95% CI
Healthy and Normal Renal Function	359.9	—
T2DM Normal Renal Function	399.6	—
T2DM Mild Renal Impairment	466.3	—
T2DM Moderate Renal Impairment	538.2	—
T2DM Severe Renal Impairment	404.8	—

Ratio (Test/Reference) of Adjusted Means111.0290% CI79.60 – 154.86

"T2DM Normal Renal Function" was test, "Healthy and Normal Renal Function" was reference.

Ratio (Test/Reference) of Adjusted Means116.7090% CI82.76 – 164.56

"T2DM Mild Renal Impairment" was test, "T2DM Normal Renal Function" was reference.

Ratio (Test/Reference) of Adjusted Means134.6890% CI96.56 – 187.85

"T2DM Moderate Renal Impairment" was test, "T2DM Normal Renal Function" was reference.

Ratio (Test/Reference) of Adjusted Means101.3190% CI72.63 – 141.30

"T2DM Severe Renal Impairment" was test, "T2DM Normal Renal Function" was reference.

Primary/registry result

Fraction Unbound (fu) of Plasma PF-06882961

Time frame:0 (pre dose), 4 hours (post dose) on Day 1

concentration, descriptive

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Healthy and Normal Renal Function	0.01519	—
T2DM Normal Renal Function	0.01542	—
T2DM Mild Renal Impairment	0.01699	—
T2DM Moderate Renal Impairment	0.01861	—
T2DM Severe Renal Impairment	0.01960	—

Ratio (Test/Reference) of Adjusted Means101.5290% CI88.89 – 115.94

"T2DM Normal Renal Function" was test, "Healthy and Normal Renal Function" was reference.

Ratio (Test/Reference) of Adjusted Means110.1790% CI96.05 – 126.37

"T2DM Mild Renal Impairment" was test, "T2DM Normal Renal Function" was reference.

Ratio (Test/Reference) of Adjusted Means120.6390% CI105.63 – 137.77

"T2DM Moderate Renal Impairment" was test, "T2DM Normal Renal Function" was reference.

Ratio (Test/Reference) of Adjusted Means127.0690% CI111.26 – 145.12

"T2DM Severe Renal Impairment" was test, "T2DM Normal Renal Function" was reference.

Primary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of Plasma PF-06882961

Time frame:0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

Cmax

concentration, descriptive

Primary/protocol endpoint

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Plasma PF-06882961

Time frame:0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of Plasma PF-06882961

Time frame:0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Fraction Unbound (fu) of Plasma PF-06882961

Time frame:0 (pre dose), 4 hours (post dose) on Day 1

descriptive

Secondary/registry result

Maximum Observed Concentration of Unbound Drug (Cmax,u) of Plasma PF-06882961

Time frame:0 (pre dose), 4 hours (post dose) on Day 1

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng/mL	95% CI
Healthy and Normal Renal Function	0.5896	—
T2DM Normal Renal Function	0.5963	—
T2DM Mild Renal Impairment	0.6662	—
T2DM Moderate Renal Impairment	1.055	—
T2DM Severe Renal Impairment	0.7680	—

Secondary/registry result

Unbound Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf,u) of Plasma PF-06882961

Time frame:0 (pre dose), 4 hours (post dose) on Day 1

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng*hr/mL	95% CI
Healthy and Normal Renal Function	5.505	—
T2DM Normal Renal Function	6.246	—
T2DM Mild Renal Impairment	7.931	—
T2DM Moderate Renal Impairment	10.01	—
T2DM Severe Renal Impairment	8.019	—

Secondary/registry result

Unbound Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast,u) of Plasma PF-06882961

Time frame:0 (pre dose), 4 hours (post dose) on Day 1

concentration, descriptive

Posted result

Group	Value (geometric_mean), ng*hr/mL	95% CI
Healthy and Normal Renal Function	5.470	—
T2DM Normal Renal Function	6.162	—
T2DM Mild Renal Impairment	7.922	—
T2DM Moderate Renal Impairment	10.01	—
T2DM Severe Renal Impairment	7.927	—

Secondary/registry result

Apparent Clearance (CL/F) of Plasma PF-06882961

Time frame:0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

concentration, descriptive

Posted result

Group	Value (geometric_mean), liter per hour (L/hr)	95% CI
Healthy and Normal Renal Function	55.17	—
T2DM Normal Renal Function	49.32	—
T2DM Mild Renal Impairment	41.08	—
T2DM Moderate Renal Impairment	36.83	—
T2DM Severe Renal Impairment	48.93	—

Secondary/registry result

Apparent Clearance of Unbound Drug After Oral Administration (CLu/F) of Plasma PF-06882961

Time frame:0 (pre dose), 4 hours (post dose) on Day 1

concentration, descriptive

Posted result

Group	Value (geometric_mean), L/hr	95% CI
Healthy and Normal Renal Function	3631	—
T2DM Normal Renal Function	3200	—
T2DM Mild Renal Impairment	2525	—
T2DM Moderate Renal Impairment	2000	—
T2DM Severe Renal Impairment	2494	—

Secondary/registry result

Apparent Volume of Distribution (Vz/F) of Plasma PF-06882961

Time frame:0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

concentration, descriptive

Posted result

Group	Value (geometric_mean), liter (L)	95% CI
Healthy and Normal Renal Function	600.8	—
T2DM Normal Renal Function	552.3	—
T2DM Mild Renal Impairment	372.5	—
T2DM Moderate Renal Impairment	438.4	—
T2DM Severe Renal Impairment	565.9	—

Secondary/registry result

Unbound Vz/F (Vz,u/F) of Plasma PF-06882961

Time frame:0 (pre dose), 4 hours (post dose) on Day 1

concentration, descriptive

Posted result

Group	Value (geometric_mean), Liter	95% CI
Healthy and Normal Renal Function	39530	—
T2DM Normal Renal Function	35810	—
T2DM Mild Renal Impairment	22890	—
T2DM Moderate Renal Impairment	23800	—
T2DM Severe Renal Impairment	28900	—

Secondary/registry result

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

Time frame:0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

concentration, descriptive

Posted result

Group	Value (median), hour (hr)	95% CI
Healthy and Normal Renal Function	5.00	3.00 – 8.00
T2DM Normal Renal Function	5.00	5.00 – 8.13
T2DM Mild Renal Impairment	6.00	3.00 – 12.0
T2DM Moderate Renal Impairment	5.50	4.00 – 6.00
T2DM Severe Renal Impairment	5.00	4.00 – 6.00

Secondary/registry result

Terminal Elimination Half-Life (T1/2) of Plasma PF-06882961

Time frame:0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

concentration, descriptive

Posted result

Group	Value (mean), hr	95% CI
Healthy and Normal Renal Function	8.111	—
T2DM Normal Renal Function	8.139	—
T2DM Mild Renal Impairment	6.640	—
T2DM Moderate Renal Impairment	8.907	—
T2DM Severe Renal Impairment	8.058	—

Secondary/registry result

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities)

Time frame:From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Healthy and Normal Renal FunctionParticipants with adverse events	1	—
Participants with serious adverse events	0	—
Participants with severe adverse events	0	—
Participants discontinued from study due to adverse events	0	—
Participants discontinued study drug due to AE and continue Study	0	—
Participants with dose reduced or temporary discontinuation due to adverse events	0	—
T2DM Normal Renal FunctionParticipants with adverse events	6	—
Participants with serious adverse events	0	—
Participants with severe adverse events	0	—
Participants discontinued from study due to adverse events	0	—
Participants discontinued study drug due to AE and continue Study	0	—
Participants with dose reduced or temporary discontinuation due to adverse events	0	—
T2DM Mild Renal ImpairmentParticipants with adverse events	1	—
Participants with serious adverse events	0	—
Participants with severe adverse events	0	—
Participants discontinued from study due to adverse events	0	—
Participants discontinued study drug due to AE and continue Study	0	—
Participants with dose reduced or temporary discontinuation due to adverse events	0	—
T2DM Moderate Renal ImpairmentParticipants with adverse events	2	—
Participants with serious adverse events	0	—
Participants with severe adverse events	0	—
Participants discontinued from study due to adverse events	0	—
Participants discontinued study drug due to AE and continue Study	0	—
Participants with dose reduced or temporary discontinuation due to adverse events	0	—
T2DM Severe Renal ImpairmentParticipants with adverse events	2	—
Participants with serious adverse events	0	—
Participants with severe adverse events	0	—
Participants discontinued from study due to adverse events	0	—
Participants discontinued study drug due to AE and continue Study	0	—
Participants with dose reduced or temporary discontinuation due to adverse events	0	—

Secondary/registry result

Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

Time frame:From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Healthy and Normal Renal FunctionHematology: Erythrocytes (10^6/mm^3) < 0.8x LLN	0	—
Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) < 0.9x LLN	0	—
Hematology: Lymphocytes (10^3/mm^3) < 0.8x LLN	0	—
Hematology: Eosinophils (10^3/mm^3) > 1.2x ULN	0	—
Clinical Chemistry: Bilirubin (mg/dL) > 1.5x ULN	1	—
Clinical Chemistry: Blood Urea Nitrogen (mg/dL) > 1.3x ULN	0	—
Clinical Chemistry: Creatinine (mg/dL) > 1.3x ULN	0	—
Clinical Chemistry: Urate (mg/dL) > 1.2x ULN	0	—
Clinical Chemistry: Magnesium (mg/dL) < 0.9x LLN	0	—
Clinical Chemistry: Phosphate (mg/dL) > 1.2x ULN	0	—
Clinical Chemistry: Bicarbonate (mEq/L) < 0.9x LLN	0	—
Clinical Chemistry: Glucose (mg/dL) > 1.5x ULN	0	—
Clinical Chemistry: Triacylglycerol Lipase (U/L) > 1.5x ULN	0	—
Urinalysis: URINE Glucose (Scalar) ≥ 1	0	—
Urinalysis: URINE Protein (Scalar) ≥ 1	0	—
Urinalysis: Leukocyte Esterase ≥ 1	0	—
Urinalysis: Hyaline Casts (/LPF) > 1	0	—
Urinalysis: Bacteria (/HPF) > 20	1	—
T2DM Normal Renal FunctionHematology: Erythrocytes (10^6/mm^3) < 0.8x LLN	0	—
Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) < 0.9x LLN	0	—
Hematology: Lymphocytes (10^3/mm^3) < 0.8x LLN	0	—
Hematology: Eosinophils (10^3/mm^3) > 1.2x ULN	0	—
Clinical Chemistry: Bilirubin (mg/dL) > 1.5x ULN	0	—
Clinical Chemistry: Blood Urea Nitrogen (mg/dL) > 1.3x ULN	0	—
Clinical Chemistry: Creatinine (mg/dL) > 1.3x ULN	0	—
Clinical Chemistry: Urate (mg/dL) > 1.2x ULN	0	—
Clinical Chemistry: Magnesium (mg/dL) < 0.9x LLN	0	—
Clinical Chemistry: Phosphate (mg/dL) > 1.2x ULN	0	—
Clinical Chemistry: Bicarbonate (mEq/L) < 0.9x LLN	0	—
Clinical Chemistry: Glucose (mg/dL) > 1.5x ULN	4	—
Clinical Chemistry: Triacylglycerol Lipase (U/L) > 1.5x ULN	2	—
Urinalysis: URINE Glucose (Scalar) ≥ 1	1	—
Urinalysis: URINE Protein (Scalar) ≥ 1	0	—
Urinalysis: Leukocyte Esterase ≥ 1	1	—
Urinalysis: Hyaline Casts (/LPF) > 1	0	—
Urinalysis: Bacteria (/HPF) > 20	0	—
T2DM Mild Renal ImpairmentHematology: Erythrocytes (10^6/mm^3) < 0.8x LLN	0	—
Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) < 0.9x LLN	2	—
Hematology: Lymphocytes (10^3/mm^3) < 0.8x LLN	0	—
Hematology: Eosinophils (10^3/mm^3) > 1.2x ULN	1	—
Clinical Chemistry: Bilirubin (mg/dL) > 1.5x ULN	0	—
Clinical Chemistry: Blood Urea Nitrogen (mg/dL) > 1.3x ULN	4	—
Clinical Chemistry: Creatinine (mg/dL) > 1.3x ULN	0	—
Clinical Chemistry: Urate (mg/dL) > 1.2x ULN	1	—
Clinical Chemistry: Magnesium (mg/dL) < 0.9x LLN	0	—
Clinical Chemistry: Phosphate (mg/dL) > 1.2x ULN	0	—
Clinical Chemistry: Bicarbonate (mEq/L) < 0.9x LLN	0	—
Clinical Chemistry: Glucose (mg/dL) > 1.5x ULN	3	—
Clinical Chemistry: Triacylglycerol Lipase (U/L) > 1.5x ULN	0	—
Urinalysis: URINE Glucose (Scalar) ≥ 1	2	—
Urinalysis: URINE Protein (Scalar) ≥ 1	0	—
Urinalysis: Leukocyte Esterase ≥ 1	0	—
Urinalysis: Hyaline Casts (/LPF) > 1	0	—
Urinalysis: Bacteria (/HPF) > 20	0	—
T2DM Moderate Renal ImpairmentHematology: Erythrocytes (10^6/mm^3) < 0.8x LLN	0	—
Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) < 0.9x LLN	0	—
Hematology: Lymphocytes (10^3/mm^3) < 0.8x LLN	0	—
Hematology: Eosinophils (10^3/mm^3) > 1.2x ULN	1	—
Clinical Chemistry: Bilirubin (mg/dL) > 1.5x ULN	0	—
Clinical Chemistry: Blood Urea Nitrogen (mg/dL) > 1.3x ULN	5	—
Clinical Chemistry: Creatinine (mg/dL) > 1.3x ULN	3	—
Clinical Chemistry: Urate (mg/dL) > 1.2x ULN	1	—
Clinical Chemistry: Magnesium (mg/dL) < 0.9x LLN	1	—
Clinical Chemistry: Phosphate (mg/dL) > 1.2x ULN	0	—
Clinical Chemistry: Bicarbonate (mEq/L) < 0.9x LLN	0	—
Clinical Chemistry: Glucose (mg/dL) > 1.5x ULN	5	—
Clinical Chemistry: Triacylglycerol Lipase (U/L) > 1.5x ULN	1	—
Urinalysis: URINE Glucose (Scalar) ≥ 1	2	—
Urinalysis: URINE Protein (Scalar) ≥ 1	4	—
Urinalysis: Leukocyte Esterase ≥ 1	0	—
Urinalysis: Hyaline Casts (/LPF) > 1	0	—
Urinalysis: Bacteria (/HPF) > 20	0	—
T2DM Severe Renal ImpairmentHematology: Erythrocytes (10^6/mm^3) < 0.8x LLN	1	—
Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) < 0.9x LLN	0	—
Hematology: Lymphocytes (10^3/mm^3) < 0.8x LLN	1	—
Hematology: Eosinophils (10^3/mm^3) > 1.2x ULN	0	—
Clinical Chemistry: Bilirubin (mg/dL) > 1.5x ULN	0	—
Clinical Chemistry: Blood Urea Nitrogen (mg/dL) > 1.3x ULN	8	—
Clinical Chemistry: Creatinine (mg/dL) > 1.3x ULN	8	—
Clinical Chemistry: Urate (mg/dL) > 1.2x ULN	0	—
Clinical Chemistry: Magnesium (mg/dL) < 0.9x LLN	0	—
Clinical Chemistry: Phosphate (mg/dL) > 1.2x ULN	2	—
Clinical Chemistry: Bicarbonate (mEq/L) < 0.9x LLN	1	—
Clinical Chemistry: Glucose (mg/dL) > 1.5x ULN	3	—
Clinical Chemistry: Triacylglycerol Lipase (U/L) > 1.5x ULN	2	—
Urinalysis: URINE Glucose (Scalar) ≥ 1	2	—
Urinalysis: URINE Protein (Scalar) ≥ 1	4	—
Urinalysis: Leukocyte Esterase ≥ 1	1	—
Urinalysis: Hyaline Casts (/LPF) > 1	1	—
Urinalysis: Bacteria (/HPF) > 20	0	—

Secondary/registry result

Number of Participants With Abnormal Vital Signs

Time frame:From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Healthy and Normal Renal FunctionSITTING SYSTOLIC BLOOD PRESSURE (MMHG): Value < 90mmHg	0	—
SITTING SYSTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 30mmHg increase	0	—
SITTING SYSTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 30mmHg decrease	0	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Value < 50 mmHg	0	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 20mmHg increase	0	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 20mmHg decrease	0	—
PULSE RATE (BPM): Value < 40 bpm	0	—
PULSE RATE (BPM): Value > 120 bpm	0	—
T2DM Normal Renal FunctionSITTING SYSTOLIC BLOOD PRESSURE (MMHG): Value < 90mmHg	0	—
SITTING SYSTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 30mmHg increase	0	—
SITTING SYSTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 30mmHg decrease	0	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Value < 50 mmHg	0	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 20mmHg increase	0	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 20mmHg decrease	0	—
PULSE RATE (BPM): Value < 40 bpm	0	—
PULSE RATE (BPM): Value > 120 bpm	0	—
T2DM Mild Renal ImpairmentSITTING SYSTOLIC BLOOD PRESSURE (MMHG): Value < 90mmHg	0	—
SITTING SYSTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 30mmHg increase	0	—
SITTING SYSTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 30mmHg decrease	0	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Value < 50 mmHg	0	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 20mmHg increase	1	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 20mmHg decrease	0	—
PULSE RATE (BPM): Value < 40 bpm	0	—
PULSE RATE (BPM): Value > 120 bpm	0	—
T2DM Moderate Renal ImpairmentSITTING SYSTOLIC BLOOD PRESSURE (MMHG): Value < 90mmHg	0	—
SITTING SYSTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 30mmHg increase	1	—
SITTING SYSTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 30mmHg decrease	0	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Value < 50 mmHg	0	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 20mmHg increase	1	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 20mmHg decrease	0	—
PULSE RATE (BPM): Value < 40 bpm	0	—
PULSE RATE (BPM): Value > 120 bpm	0	—
T2DM Severe Renal ImpairmentSITTING SYSTOLIC BLOOD PRESSURE (MMHG): Value < 90mmHg	0	—
SITTING SYSTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 30mmHg increase	1	—
SITTING SYSTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 30mmHg decrease	1	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Value < 50 mmHg	0	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 20mmHg increase	1	—
SITTING DIASTOLIC BLOOD PRESSURE (MMHG): Chg ≥ 20mmHg decrease	0	—
PULSE RATE (BPM): Value < 40 bpm	0	—
PULSE RATE (BPM): Value > 120 bpm	0	—

Secondary/registry result

Number of Participants With Abnormal Electrocardiograms (ECGs)

Time frame:From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Healthy and Normal Renal FunctionPR INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value ≥ 300	0	—
PR INTERVAL NOT OTHERWISE SPECIFIED (MSEC): %Chg ≥ 25/50%	0	—
QRS INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value ≥ 140	0	—
QRS INTERVAL NOT OTHERWISE SPECIFIED (MSEC): %Chg ≥ 50%	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 450 < Value ≤ 480	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 480 < Value ≤ 500	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): Value > 500	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 30 < Chg ≤ 60	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): Chg > 60	0	—
T2DM Normal Renal FunctionPR INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value ≥ 300	0	—
PR INTERVAL NOT OTHERWISE SPECIFIED (MSEC): %Chg ≥ 25/50%	0	—
QRS INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value ≥ 140	1	—
QRS INTERVAL NOT OTHERWISE SPECIFIED (MSEC): %Chg ≥ 50%	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 450 < Value ≤ 480	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 480 < Value ≤ 500	1	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): Value > 500	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 30 < Chg ≤ 60	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): Chg > 60	0	—
T2DM Mild Renal ImpairmentPR INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value ≥ 300	0	—
PR INTERVAL NOT OTHERWISE SPECIFIED (MSEC): %Chg ≥ 25/50%	0	—
QRS INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value ≥ 140	0	—
QRS INTERVAL NOT OTHERWISE SPECIFIED (MSEC): %Chg ≥ 50%	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 450 < Value ≤ 480	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 480 < Value ≤ 500	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): Value > 500	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 30 < Chg ≤ 60	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): Chg > 60	0	—
T2DM Moderate Renal ImpairmentPR INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value ≥ 300	0	—
PR INTERVAL NOT OTHERWISE SPECIFIED (MSEC): %Chg ≥ 25/50%	0	—
QRS INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value ≥ 140	0	—
QRS INTERVAL NOT OTHERWISE SPECIFIED (MSEC): %Chg ≥ 50%	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 450 < Value ≤ 480	1	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 480 < Value ≤ 500	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): Value > 500	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 30 < Chg ≤ 60	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): Chg > 60	0	—
T2DM Severe Renal ImpairmentPR INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value ≥ 300	0	—
PR INTERVAL NOT OTHERWISE SPECIFIED (MSEC): %Chg ≥ 25/50%	0	—
QRS INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value ≥ 140	0	—
QRS INTERVAL NOT OTHERWISE SPECIFIED (MSEC): %Chg ≥ 50%	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 450 < Value ≤ 480	2	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 480 < Value ≤ 500	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): Value > 500	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): 30 < Chg ≤ 60	0	—
QTCF NOT OTHERWISE SPECIFIED (MSEC): Chg > 60	0	—

Secondary/protocol endpoint

Maximum Observed Concentration of Unbound Drug (Cmax,u) of Plasma PF-06882961

Time frame:0 (pre dose), 4 hours (post dose) on Day 1

Cmax

concentration, descriptive

Secondary/protocol endpoint

Unbound Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf,u) of Plasma PF-06882961

Time frame:0 (pre dose), 4 hours (post dose) on Day 1

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint/low confidence

Unbound Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast,u) of Plasma PF-06882961

Time frame:0 (pre dose), 4 hours (post dose) on Day 1

concentration, descriptive

Secondary/protocol endpoint

Apparent Clearance (CL/F) of Plasma PF-06882961

Time frame:0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

descriptive

Secondary/protocol endpoint

Apparent Clearance of Unbound Drug After Oral Administration (CLu/F) of Plasma PF-06882961

Time frame:0 (pre dose), 4 hours (post dose) on Day 1

descriptive

Secondary/protocol endpoint

Apparent Volume of Distribution (Vz/F) of Plasma PF-06882961

Time frame:0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

descriptive

Secondary/protocol endpoint

Unbound Vz/F (Vz,u/F) of Plasma PF-06882961

Time frame:0 (pre dose), 4 hours (post dose) on Day 1

descriptive

Secondary/protocol endpoint

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

Time frame:0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

Tmax

concentration, descriptive

Secondary/protocol endpoint

Terminal Elimination Half-Life (T1/2) of Plasma PF-06882961

Time frame:0 (pre dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours (post dose) on Day 1, 24 and 36 hours (post dose) on Day 2, 48 hours (post dose) on Day 3

Half-life

descriptive

Secondary/protocol endpoint

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities)

Time frame:From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

Time frame:From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)

event count, event

Secondary/protocol endpoint

Number of Participants With Abnormal Vital Signs

Time frame:From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Abnormal Electrocardiograms (ECGs)

Time frame:From the first dose of study intervention to the last dose of study treatment date +35 days (up to 13 months)

threshold achievement, event

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

Effect of Renal Impairment on the Pharmacokinetics of a Single Oral Dose of Danuglipron in Participants With Type 2 Diabetes.
Journal of clinical pharmacology2024 Apr (month)PMID37840155doi:10.1002/jcph.2371via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 1, 2026 snapshot.