GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961

A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06882961

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•Male•Healthy volunteers

Primary endpoint

•Total recovery of radioactivity in urine and feces

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 IDNCT04495140

Org study IDC3421009

Secondary ID2019-002584-10

Timeline

Milestones

Study start2020-07-22actual

Study first posted2020-07-31actual

Primary completion2020-10-15actual

Study completion2020-10-15actual

Last update posted2020-11-25actual

Assets

Investigational agents

Danuglipron

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age54 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Male participants between 18 to 54 years of age

•Healthy and capable of signing informed consent document

•Willing to comply to all scheduled visits, lab tests, lifestyle considerations and study procedures

•Body mass index (BMI) of 17.5 to 30 kg/m2; and a total body weight ≥50 kg (110 lb).

Exclusion criteria

•acute or chronic medical or psychiatric condition including recent (within the past year)

•Surgical procedures like gastrectomy, cholecystectomy, Irregularity in bowel movements

•Use of prescription or non-prescription drugs and dietary and herbal supplements within 14 days prior to the first dose of investigational product.

•Previous administration with an investigational drug within 60 days (or as determined by the local requirement) preceding the first dose of investigational product used in this study.

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

•A positive urine drug test on screening or Day -1.

•Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), 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.

•Participants with abnormalities in clinical laboratory tests including ECGs, vital signs, liver function tests, myocardial infarction

•Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.

•History of alcohol or tobacco abuse or binge drinking and/or any other illicit drug use or dependence within past 6 months.

•Subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.

•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.

•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 Pfizer employees, including their family members, directly involved in the conduct of the study.

Endpoints (21)

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

Safety / tolerability / PK

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint/low confidence

Number of participants with vital measurements above/below certain threshold

Time frame:baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)

threshold achievement, descriptive

Safety / tolerability / PK

20 endpoints

Primary/protocol endpoint

Total recovery of radioactivity in urine and feces, following oral administration of [14C] PF-06882961 in period 1

Time frame:Baseline through approximately hour 312 (day 14). Period 1 is 14 days

percent change from baseline, descriptive

Secondary/protocol endpoint

Metabolite profiling/identification in plasma, urine, and feces

Time frame:0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312 hour (hr)

descriptive

Secondary/protocol endpoint

Plasma Cmax to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961

Time frame:0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr

Cmax

concentration, descriptive

Secondary/protocol endpoint

Plasma Tmax to describe the PK of total radioactivity following administration of single, oral dose of [14C]PF-06882961

Time frame:0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr

Tmax

descriptive

Secondary/protocol endpoint

Plasma AUClast to describe PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961

Time frame:0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr

concentration, descriptive

Secondary/protocol endpoint

Plasma AUCinf to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961

Time frame:0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Plasma elimination t½ to describe plasma PK of total radioactivity following administration of single, oral dose of [14C] PF-06882961

Time frame:00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr

Half-life

descriptive

Secondary/protocol endpoint

Plasma Cmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961

Time frame:0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr

Cmax

concentration, descriptive

Secondary/protocol endpoint

Plasma Tmax to describe the plasma PK of PF-06882961 following administration of single, oral dose of [14C]PF-06882961

Time frame:0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr

Tmax

concentration, descriptive

Secondary/protocol endpoint

Plasma AUClast to describe PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961

Time frame:0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr

concentration, descriptive

Secondary/protocol endpoint

Plasma AUCinf to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961

Time frame:0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Mean residence Time (MRT )following administration of a single, intravenous dose of [14C]PF 06882961

Time frame:0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr

descriptive

Secondary/protocol endpoint

Systemic Clearance (CL) following administration of a single, intravenous dose of [14C]PF 06882961

Time frame:0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr

descriptive

Secondary/protocol endpoint

Volume of distribution at steady state (Vss) following administration of a single, intravenous dose of [14C]PF 06882961

Time frame:0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr

descriptive

Secondary/protocol endpoint

Absolute oral bioavailability (F)

Time frame:0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr

descriptive

Secondary/protocol endpoint

Fraction of dose absorbed following single oral administration of [14C]PF-06882961

Time frame:0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312hr

ratio, descriptive

Secondary/protocol endpoint

Number of participants with adverse events

Time frame:Baseline in Period 1 up to 32 days after the period 2 doses, for a total of approximately 46 days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Plasma elimination t½ to describe plasma PK of PF-06882961 following administration of single, oral dose of [14C] PF-06882961

Time frame:00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr

Half-life

descriptive

Secondary/protocol endpoint

Number of participants with safety laboratory test results above/below certain threshold

Time frame:baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)

threshold achievement, event

Secondary/protocol endpoint

Number of participants with ECG measurements above/below certain threshold

Time frame:baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)

threshold achievement, event

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.