GLP-1 Peptide Atlas, by Delfa

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CompletedPhase 1

A Trial Investigating the Effect of Probenecid and Ciclosporin on the Concentrations of SNAC in Healthy Subjects

A Trial Investigating the Effect of Probenecid and Ciclosporin on the Pharmacokinetics of SNAC in Healthy Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18.5-29.9•Healthy volunteers

Primary endpoints

•AUC0-tz,SNAC,SD, AUC of SNAC from time 0 to time of the last quantifiable•Cmax,SNAC,SD, maximum observed SNAC plasma concentration on

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 IDNCT03466567

Org study IDNN9924-4394

Secondary ID2017-002498-21European Medicines Agency (EudraCT)

Secondary IDU1111-1197-9088World Health Organization (WHO)

Timeline

Milestones

Study first posted2018-03-15actual

Study start2018-03-15actual

Primary completion2018-07-10actual

Study completion2018-07-10actual

Last update posted2019-06-19actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female of non-childbearing potential, aged 18-64 years (both inclusive) at the time of signing informed consent.

•Body mass index between 18.5 and 29.9 kg/sqm (both inclusive).

•Body weight greater than or equal to 50.0 kg.

•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

- Use of tobacco and nicotine products, defined as: A. Smoking more than 1 cigarette or the equivalent per day B. Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house period(s).

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

•History (as declared by the subject) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

•Known glucose-6-phosphate-dehydrogenase deficiency (as declared by the subject).

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.

Safety / tolerability / PK

12 endpoints

Primary/protocol endpoint

AUC0-tz,SNAC,SD, area under the SNAC plasma concentration-time curve from time 0 to time of the last quantifiable concentration after a single dose of oral semaglutide

Time frame:0-48 hours

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cmax,SNAC,SD, maximum observed SNAC plasma concentration on the concentration-time curve after a single dose of oral semaglutide

Time frame:0-48 hours

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-tz,E494,SD, area under the SNAC metabolite E494 plasma concentration-time curve from time 0 to time of the last quantifiable concentration after a single dose of oral semaglutide

Time frame:0-48 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,E494,SD, maximum observed SNAC metabolite E494 plasma concentration on the concentration-time curve after a single dose of oral semaglutide

Time frame:0-48 hours

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-tz,E506,SD, area under the SNAC metabolite E506 plasma concentration-time curve from time 0 to time of the last quantifiable concentration after a single dose of oral semaglutide

Time frame:0-48 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,E506,SD, maximum observed SNAC metabolite E506 plasma concentration on the concentration-time curve after a single dose of oral semaglutide

Time frame:0-48 hours

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-∞,E1245,SD, area under the SNAC metabolite E1245 plasma concentration-time curve from time 0 to infinity after a single dose of oral semaglutide

Time frame:0-48 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,E1245,SD, maximum observed SNAC metabolite E1245 plasma concentration on the concentration-time curve after a single dose of oral semaglutide

Time frame:0-48 hours

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-∞,E1246,SD, area under the SNAC metabolite E1246 plasma concentration-time curve from time 0 to infinity after a single dose of oral semaglutide

Time frame:0-48 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,E1246,SD, maximum observed SNAC metabolite E1246 plasma concentration on the concentration-time curve after a single dose of oral semaglutide

Time frame:0-48 hours

Cmax

concentration, descriptive

Secondary/protocol endpoint

AUC0-∞,E1247,SD, area under the SNAC metabolite E1247 plasma concentration-time curve from time 0 to infinity after a single dose of oral semaglutide

Time frame:0-48 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,E1247,SD, maximum observed SNAC metabolite E1247 plasma concentration on the concentration-time curve after a single dose of oral semaglutide

Time frame:0-48 hours

Cmax

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.