GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study Looking at New Protein-based Tablets in Healthy Male Participants

A Study Investigating Pharmacokinetic Properties When Dosing Different Formulations of Oral Peptide Therapeutics in Healthy Male Participants

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

384

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-29.9•Male•Healthy volunteers

Primary endpoint

•AUC0-24h,API,day10

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 IDNCT05129891

Org study IDNN9501-4821

Secondary ID2021-001452-34

Secondary IDU1111-1266-0672World Health Organization (WHO)

Timeline

Milestones

Study start2021-11-03actual

Study first posted2021-11-22actual

Primary completion2023-02-26actual

Study completion2023-05-04actual

Last update posted2024-05-29actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Male.

•Aged 18-55 years (both inclusive) at the time of signing informed consent.

•Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive).

•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.

Exclusion criteria

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

•Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening.

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

•Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.

•History (as declared by the participant or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of study products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

Endpoints (3)

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

3 endpoints

Primary/protocol endpoint

AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose

Time frame:From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose

Time frame:From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API

Time frame:From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration

Tmax

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.