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Delfa

← All trials/NCT04513704

CompletedPhase 1

A Clinical Trial Comparing Semaglutide in Healthy People Who Eat and Take the Medicine at Different Times

Oral Semaglutide Pharmacokinetics in Healthy Subjects, Effect of Dosing Schedules

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

156

Study population

Healthy volunteers

Eligibility highlights

•BMI 20-29.9•Healthy volunteers

Primary endpoint

•AUC of semaglutide during a dosing interval after the 10th dosing

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 IDNCT04513704
Org study IDNN9924-4556
Secondary ID2019-004569-42European Medicines Agency (EudraCT)
Secondary IDU1111-1243-9641World Health Organization (WHO)

Timeline

Milestones

Study first posted2020-08-14actual
Study start2020-08-28actual
Primary completion2021-04-20actual
Study completion2021-05-26actual
Last update posted2023-05-12actual

Assets

Investigational agents

Semaglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Male or female, aged 18-64 years (both inclusive) at time of signing informed consent.
•Body mass index (BMI) 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

•Glycated haemoglobin (HbA1c) greater than or equal to 6.5% (48 mmol/mol) at screening.
•Use of tobacco and nicotine products, defined as any of the below:
-Smoking more than 5 cigarettes or the equivalent per day
-Not willing to refrain from smoking and use of nicotine substitute products during the in-house period.
•Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
•Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by subject or reported in the medical records).
•Presence or history (as declared by subject or reported in the medical records) of pancreatitis (acute or chronic).
•History (as declared by subject or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of trial 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

Area under the semaglutide plasma concentration - time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,day10)

Time frame:From 0 to 24 hours after the 10th dosing (day 10)

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed semaglutide plasma concentration after the 10th dosing (Cmax,0-24h,sema,day10)

Time frame:From 0 to 24 hours after the 10th dosing (day 10)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time to maximum observed semaglutide plasma concentration after the 10th dosing (tmax,0-24h,sema,day10)

Time frame:From 0 to 24 hours after the 10th dosing (day 10)

Tmax

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.