GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults

A Phase 1, 4-Part, Open-Label, Randomized Study With A 5-Period, 4 Sequence, Crossover Design to Compare the Single Dose Pharmacokinetics Between Immediate and Modified Release Formulations of Danuglipron Administered Orally to Healthy Adult Participants

Lead sponsor

Pfizer

Asset

Danuglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 16-32•Healthy volunteers

Primary endpoints

•Parts A, C and D only•Part B only

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 IDNCT06153758

Org study IDC3421074

Timeline

Milestones

Study start2023-11-27actual

Study first posted2023-12-01actual

Primary completion2024-09-30actual

Study completion2024-09-30actual

Last update posted2024-10-21actual

Assets

Investigational agents

Danuglipron

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•18 years or older and overtly healthy

•Body mass Index (BMI) between 16-32 kg/m2; and a total body weight >50 kg (110 lb)

Exclusion criteria

•Evidence or history of clinically significant medical conditions or laboratory abnormality

•Any condition possibly affecting drug absorption

•Known intolerance/hypersensitivity to a GLP-1 R agonist

•Use of prescription drugs, nonprescription drugs, dietary supplements or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of danuglipron in each part of the study.

Endpoints (13)

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

13 endpoints

Primary/protocol endpoint

Parts A, C and D only: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fasted state

Time frame:Predose to 48 hours post danuglipron administration

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Parts A, C and D only: Maximum observed concentration (Cmax) for danuglipron in the fasted state

Time frame:Predose to 48 hours post danuglipron administration

Cmax

concentration, descriptive

Primary/protocol endpoint

Parts A, C and D only: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fasted state

Time frame:Predose to 48 hours post danuglipron administration

concentration, descriptive

Primary/protocol endpoint

Part B only: Dose normalized area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf,dn), as data permit, for danuglipron in the fasted state

Time frame:Predose to 48 hours post danuglipron administration

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Part B only: Dose normalized maximum observed concentration (Cmax,dn) for danuglipron in the fasted state

Time frame:Predose to 48 hours post danuglipron administration

Cmax

concentration, descriptive

Primary/protocol endpoint

Part B only: Dose normalized area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast,dn) for danuglipron (only if AUCinf,dn is not reportable) in the fasted state

Time frame:Predose to 48 hours post danuglipron administration

concentration, descriptive

Secondary/protocol endpoint

All Parts: Number of Participants reporting Treatment Emergent Adverse Events

Time frame:From baseline up to 28-35 days post last dose taken

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

All Parts: Number of Participants reporting Clinically Significant ECG Abnormalities

Time frame:From baseline up to 28-35 days post last dose taken

event count, event

Secondary/protocol endpoint

All Parts: Number of Participants reporting Clinically Significant Vital Sign Abnormalities

Time frame:From baseline up to 28-35 days post last dose taken

descriptive

Secondary/protocol endpoint

All Parts: Number of participants reporting clinically significant clinical laboratory abnormalities

Time frame:From baseline up to 28-35 days post last dose taken

event count, event

Secondary/protocol endpoint

All Parts: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fed state

Time frame:Predose to 48 hours post danuglipron administration

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

All Parts: Maximum observed concentration (Cmax) for danuglipron in the fed state

Time frame:Predose to 48 hours post danuglipron administration

Cmax

concentration, descriptive

Secondary/protocol endpoint

All Parts: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fed state

Time frame:Predose to 48 hours post danuglipron administration

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.