CompletedPhase 1

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

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 22-31.9•Male•Healthy volunteers

Primary endpoints

•Adjusted AUC(sema)•Adjusted Cmax,(sema)•Adjusted tmax,sema

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06642584

Org study IDNN9501-5006

Secondary IDU1111-1304-9627World Health Organisation (WHO)

Timeline

Milestones

Study first posted2024-10-15actual

Study start2024-10-15actual

Primary completion2025-07-10actual

Study completion2025-08-13actual

Last update posted2025-10-20actual

Assets

Investigational agents

Semaglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

1. Male.

2. Age 18-64 years (both inclusive) at the time of signing the informed consent.

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

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

Exclusion criteria

1. Known or suspected hypersensitivity to study interventions or related products.

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

3. 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 prior to first dosing.

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 AUC(sema); adjusted area under the semaglutide plasma concentration-time curve

Time frame:From 0 to 24 hours after dosing on Days 122 and 132.

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Adjusted Cmax,(sema); adjusted maximum observed semaglutide plasma concentration

Time frame:From 0 to 24 hours after dosing on Days 122 and 132.

Cmax

concentration, descriptive

Primary/protocol endpoint

Adjusted tmax,sema; time to adjusted maximum observed semaglutide plasma concentration

Time frame:From 0 to 24 hours after dosing on Days 122 and 132.

Tmax

descriptive

Primary/protocol endpoint

t½,sema; the terminal half-life of semaglutide

Time frame:From 0 to 840 hours after dosing on Day 132.

Half-life

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.