GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study to Learn How Different Amounts of the Study Medicine Danuglipron Are Taken up Into the Blood in Otherwise Healthy Adults With Overweight or Obesity

A PHASE 1, OPEN- LABEL STUDY TO EVALUATE THE MULTIPLE DOSE PHARMACOKINETICS OF DANUGLIPRON FOLLOWING ORAL ADMINISTRATION IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY

Lead sponsor

Pfizer

Asset

Danuglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criterion

•BMI 25-45.4

Primary endpoints

•Steady-state area under the concentration-time profile from time zero•Steady-state Cmax for danuglipron•Steady-state time to reach Cmax (Tmax) for danuglipron

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 IDNCT06568731

Org study IDC3421069

Timeline

Milestones

Study first posted2024-08-23actual

Study start2024-08-23actual

Primary completion2024-12-18actual

Study completion2024-12-18actual

Last update posted2025-01-20actual

Assets

Investigational agents

Danuglipron

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Eligibility criteria

Key Inclusion Criteria:

•18 years of age or older

•Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight >50 kg (110 lb)

Key Exclusion Criteria:

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

•Any condition possibly affecting drug absorption

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

Endpoints (8)

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

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change from baseline in body weight

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

Body weight, absolute change (kg)

change from baseline, improvement

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron

Time frame:Predose to 24 hours post danuglipron administration

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Steady-state maximum observed concentration (Cmax) for danuglipron

Time frame:Predose to 24 hours post danuglipron administration

Cmax

concentration, descriptive

Primary/protocol endpoint

Steady-state time to reach maximum observed concentration (Tmax) for danuglipron

Time frame:Predose to 24 hours post danuglipron administration

Tmax

descriptive

Secondary/protocol endpoint

Number of participants reporting Treatment Emergent Adverse Events (TEAEs)

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

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

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

Number of participants reporting clinically significant vital sign abnormalities

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

event count, event

Secondary/protocol endpoint

Number of participants reporting clinically significant changes ECG abnormalities

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

event count, 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.