DelfaGLP-1 Atlas

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CompletedPhase 1

A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People

A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

3

Recruiting sites

—

Enrollment

546

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 21-32•Healthy volunteers

Primary endpoints

•AUC0-24h,semaglutide,SS AUC of semaglutide during a dosing interval at steady•Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady

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 IDNCT05227196
Org study IDNN9924-4799

Timeline

Milestones

Study start2022-02-04actual
Study first posted2022-02-07actual
Primary completion2023-06-28actual
Study completion2023-08-08actual
Last update posted2024-09-19actual

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, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 21.0 and 32.0 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

•HbA1c equal to or greater than 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 within 48 hours prior to and during the inpatient periods
•Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
•History(a) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant(a).
•Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma(a).

1. As declared by the participant or reported in the medical records

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

AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS)

Time frame:24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state

Time frame:24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state

Time frame:24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.

Tmax

descriptive

Secondary/protocol endpoint

Ctau,24h,semaglutide,SS Semaglutide plasma concentration 24 hours after last dose at steady state

Time frame:24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.

Plasma concentration (steady state)

concentration, 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 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.