GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study to Learn How the Study Medicine Danuglipron is Taken Up Into the Blood and If Danuglipron Changes How the Body Processes Other Study Medicines (Atorvastatin and Rosuvastatin) in Healthy Adults Who Are Overweight or Obese

A Two-Part Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Multiple Dose Pharmacokinetics of Danuglipron Following Oral Administration and The Effects of Steady-State Danuglipron on the Pharmacokinetics of Single Oral Dose of Atorvastatin and Rosuvastatin 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 IDNCT06567327

Org study IDC3421086

Timeline

Milestones

Study first posted2024-08-22actual

Study start2024-08-28actual

Primary completion2025-03-16actual

Study completion2025-04-14actual

Last update posted2025-08-06actual

Assets

Investigational agents

Danuglipron

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersAccepted

Eligibility criteria

Key Inclusion Criteria:

•18 to < 65 years of age

•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 and/or known hypersensitivity or contraindication to atorvastatin (Cohort 1 and 3 participants) or rosuvastatin (Cohort 2 and 4 participants)

Endpoints (12)

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

11 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

Primary/protocol endpoint

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

Time frame:Predose to 72 hours post atorvastatin administration

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for atorvastatin (only if AUCinf is not reportable)

Time frame:Predose to 72 hours post atorvastatin administration

concentration, descriptive

Primary/protocol endpoint

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

Time frame:Predose to 96 hours post rosuvastatin administration

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for rosuvastatin (only if AUCinf is not reportable)

Time frame:Predose to 96 hours post rosuvastatin administration

AUC₀–∞

concentration, 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.