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CompletedPhase 1

A Research Study to Compare How Much Semaglutide is Found in the Blood With Different Tablets of Oral Semaglutide in Healthy Participants

A Randomised Study to Investigate Steady State Semaglutide Exposure of a New Formulation of Oral Semaglutide in Healthy Participants

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

3

Recruiting sites

Enrollment

264

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 23-34.9Healthy volunteers

Primary endpoint

AUC0-24h,semaglutide,SS

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 IDNCT05784402
Org study IDNN9924-4891
Secondary IDU1111-1279-6289World Health Organization (WHO)

Timeline

Milestones

Study start2023-03-16actual
Study first posted2023-03-24actual
Primary completion2024-02-23actual
Study completion2024-03-29actual
Last update posted2025-12-02actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Body mass index (BMI) between 23.0 and 34.9 kilograms per meter square (kg/m^2) (both inclusive) at screening
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

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method
Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
Use of prescription medicinal products or non-prescription drugs, except highly effective contraceptives, routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen within 14 days before screening
Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs, as judged by the investigator

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,semaglutide,SS; area under the semaglutide plasma concentration-time curve during a dosing interval at steady state

Time frame:From 0 to 24 hours after dosing on days 77, 112 and 147

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,0-24h.semaglutide,SS; maximum observed plasma concentration of semaglutide at steady state

Time frame:From 0 to 24 hours after dosing on days 77, 112 and 147

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:From 0 to 24 hours after dosing on days 77, 112 and 147

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.