DelfaGLP-1 Atlas

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CompletedPhase 1

Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

78

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 18.5-29.9

Primary endpoint

•AUC of semaglutide

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 IDNCT02172313
Org study IDNN9924-4154
Secondary ID2013-004707-39
Secondary IDU1111-1149-8127WHO

Timeline

Milestones

Study first posted2014-06-24estimated
Last update posted2014-10-21estimated
Study start2014-06 (month precision)
Primary completion2014-10actual (month precision)
Study completion2014-10actual (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Male or female subject aged 18-75 years (both inclusive) at the time of signing informed consent
•Body mass index of 18.5-29.9 kg/m^2 (both inclusive)
•A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose of oral semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices)
•History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
•Not able or not willing to refrain from smoking or use of nicotine substitute products when staying at the clinical unit
•Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
•Previous gastrointestinal surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder, pancreas or intestinal resections. Exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic- and gastric endoscopy

Endpoints (5)

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

5 endpoints
Primary/protocol endpoint

Area under the semaglutide plasma concentration time curve

Time frame:From time 0 to 24 hours after the 10th daily dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed semaglutide plasma concentration

Time frame:0 to 24 hours after the 10th daily dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time to maximum observed semaglutide plasma concentration

Time frame:0 to 24 hours after the 10th daily dose

Tmax

descriptive

Secondary/protocol endpoint

Terminal half-life of semaglutide

Time frame:After the 10th daily dose

Half-life

descriptive

Secondary/protocol endpoint

Area under the SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) plasma concentration time curve

Time frame:From time 0 to 24 hours after the 10th daily dose

AUC₀–∞

concentration, descriptive

Publications (2)

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 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.