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CompletedPhase 1

A Research Study Comparing the Effect of Different Dosing Conditions on Blood Levels of Semaglutide in a New Tablet Composition in Healthy Participants

Investigation of the Effect of Dosing Conditions on the Pharmacokinetics of New Oral Semaglutide Formulation in Healthy Participants

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

121

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 18.5-29.9MaleHealthy volunteers

Primary endpoint

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

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 IDNCT05996874
Org study IDNN9924-4977
Secondary ID2022-002848-52
Secondary IDU1111-1281-4819World Health Organization (WHO)

Timeline

Milestones

Study start2023-08-12actual
Study first posted2023-08-18actual
Primary completion2024-04-18actual
Study completion2024-04-18actual
Last update posted2025-09-24actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

Body mass index (BMI) between 18.5 and 29.9 kilograms per meter square (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 Hemoglobin (HbA1c) greater than or equal to (>=) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening
Use of tobacco and nicotine products, defined as any of the below:

1. Smoking more than 5 cigarettes or the equivalent per day

2. 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
Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
History 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

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,sema,Day10: Area under the semaglutide plasma concentration-time curve during a dosing interval after the 10th dosing

Time frame:From 0 to 24 hours after dosing on day 10

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,0-24h,sema,Day10: Maximum semaglutide plasma concentration after the 10th dosing

Time frame:From 0 to 24 hours after dosing on day 10

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,0-24h,sema,Day10: Time to maximum semaglutide plasma concentration after the 10th dosing

Time frame:From 0 to 24 hours after dosing on day 10

Tmax

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.