GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III

A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants - Oral Formulation III

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

121

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 22-31.9•Male•Healthy volunteers

Primary endpoint

•Adjusted AUC0-24h,sema

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 IDNCT06097390

Org study IDNN9501-4924

Secondary IDU1111-1289-1040World Health Organization (WHO)

Timeline

Milestones

Study start2023-09-28actual

Study first posted2023-10-24actual

Primary completion2024-02-22actual

Study completion2024-03-27actual

Last update posted2025-07-17actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexMale

Healthy volunteersAccepted

Eligibility criteria

Key inclusion criteria:

•Body mass index (BMI) between 22.0 and 31.9 kilograms per meter square (kg/m^2) (both inclusive) at screening.

•Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Key exclusion criteria:

•Known or suspected hypersensitivity to study intervention(s) or related products.

•Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

•Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days before screening.

Endpoints (4)

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

4 endpoints

Primary/protocol endpoint

Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve

Time frame:From 0 to 24 hours after dosing on day 80 and 90

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration

Time frame:From 0 to 24 hours after dosing on day 80 and 90

Cmax

concentration, descriptive

Secondary/protocol endpoint

Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration

Time frame:From 0 to 24 hours after dosing on day 80 and 90

Tmax

descriptive

Secondary/protocol endpoint

t½,sema; the terminal half-life of semaglutide

Time frame:From 0 to 840 hours after dosing on day 90

Half-life

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.