GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Single Dose Crossover Study In Healthy Subjects To Evaluate Different Formulations Of PF-06882961

A Phase 1, Open-label Study In Healthy Subjects To Evaluate The Pharmacokinetics Of Pf-06882961 Following Single Oral Administration Of Immediate Release Tablets And An Immediate Release Oral Solution In The Fed State, And Controlled Release Tablets In The Fed And Fasted States

Lead sponsor

Pfizer

Asset

Danuglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 17.5-30.5•Healthy volunteers

Primary endpoints

•Cmax for PF-06882961•Cmax (Tmax) for PF-06882961•Area under the curve

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 IDNCT03492697

Org study IDC3421003

Timeline

Milestones

Study first posted2018-04-10actual

Study start2018-04-30actual

Primary completion2018-07-18actual

Study completion2018-07-18actual

Last update posted2018-07-30actual

Assets

Investigational agents

Danuglipron

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive

•Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)

•Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Exclusion criteria

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

•Any condition possibly affecting drug absorption (eg, gastrectomy).

•A positive urine drug test.

•History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects within 6 months before screening.

•Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).

•Subjects who have previously participated in prior studies with PF 06882961 as the investigational product.

•Screening supine BP>=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest.

•Screening supine 12 lead ECG demonstrating a QTc interval >450 msec or a QRS interval >120 msec.

•Aspartate aminotransferase (AST) level >= 1.25 × upper limit of normal (ULN);

•Alanine aminotransferase (ALT) level >= 1.25 × ULN;

•Total bilirubin level >=1.5 × ULN;

•TSH > ULN;

•HbA1c >=6.5%.

•Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for at least 28 days after the last dose of investigational product.

•Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product

•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.

•History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).

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

•Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of the protocol.

•Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.

•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 investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study

Endpoints (15)

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

15 endpoints

Primary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) for PF-06882961

Time frame:0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

Cmax

concentration, descriptive

Primary/protocol endpoint

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

Time frame:0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

Tmax

descriptive

Primary/protocol endpoint

Area under the curve from time zero to last quantifiable concentration for PF-06882961 (AUClast)

Time frame:0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the curve from time zero to extrapolated infinite time for PF-06882961 (AUCinf), as data permit

Time frame:0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Observed Plasma Concentration for PF-06882961 at 24 hours post-dose (C24)

Time frame:24 hours post dose in each period

Plasma concentration (steady state)

concentration, descriptive

Primary/protocol endpoint

Plasma Decay Half-Life (t1/2) for PF-06882961, as data permit

Time frame:0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

Half-life

descriptive

Primary/protocol endpoint

Apparent clearance (CL/F) for PF-06882961, as data permit

Time frame:0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

descriptive

Primary/protocol endpoint

Peak-to-trough (PTR) ratio for PF-06882961

Time frame:0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose in each period

ratio, descriptive

Secondary/protocol endpoint

Number of subjects with treatment-emergent adverse events (AEs)

Time frame:Baseline to at least 28 days after last dose

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

AUClast for PF-06882961 for CR tablet (long) and IR tablet in fed state

Time frame:0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

concentration, descriptive

Secondary/protocol endpoint

AUCinf for PF-06882961 for CR tablet (long) and IR tablet in fed state, as data permit

Time frame:0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax for PF-06882961 for CR tablet (long) and IR tablet in fed state

Time frame:0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUClast for PF-06882961 for CR tablet (long) in fed and fasted states

Time frame:0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

concentration, descriptive

Secondary/protocol endpoint

AUCinf for PF-06882961 for CR tablet (long) in fed and fasted states, as data permit

Time frame:0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax for PF-06882961 for CR tablet (long) in fed and fasted states

Time frame:0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 28, 32, 36 and 48 hours post dose

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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.