GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Research Study Comparing New Tablets of Semaglutide in New Doses, in Healthy People

A Randomised Trial Investigating Steady State Semaglutide Exposure of 25 and 50 mg of Oral Semaglutide in Different Formulations in Healthy Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

290

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 21-29.9

Primary endpoint

•AUC of semaglutide during a dosing interval at steady state (AUC0-24h,sema,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 IDNCT04524832

Org study IDNN9924-4633

Secondary ID2019-004157-80European Medicines Agency (EudraCT)

Secondary IDU1111-1242-2643World Health Organization (WHO

Timeline

Milestones

Study first posted2020-08-24actual

Study start2020-09-29actual

Primary completion2022-02-25actual

Study completion2022-02-25actual

Last update posted2023-10-10actual

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 between 21.0 kg/m^2 and 29.9 kg/m^2 (both inclusive).

•Considered eligible 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:1) Smoking more than 5 cigarettes or the equivalent per day.2) Not willing to refrain from smoking and use of nicotine substitute products during the inpatient periods.

•Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.

•History (as declared by participant) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

•Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by participant).

•Presence or history (as declared by participant) of pancreatitis (acute or chronic).

Endpoints (11)

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.

Coverage by outcome category

Safety / tolerability / PK

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change in pulse

Time frame:From baseline (visit 2, day 1) to end of treatment (visit 10, day 113)

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change in blood pressure

Time frame:From baseline (visit 2, day 1) to end of treatment (visit 10, day 113)

change from baseline, improvement

Safety / tolerability / PK

9 endpoints

Primary/protocol endpoint

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

Time frame:From 0 to 24 hours after the last dosing of oral semaglutide 25 mg on visit 8, day 84

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

Time frame:From 0 to 24 hours after the last dosing of oral semaglutide 50 mg on visit 10, day 112

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:From 0 to 24 hours after the last dosing of oral semaglutide 11.2 mg on visit 6, day 56.

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS)

Time frame:From 0 to 24 hours after the last dosing of oral semaglutide 11.2 mg on visit 6, day 56

Cmax

concentration, descriptive

Secondary/protocol endpoint

Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS)

Time frame:From 0 to 24 hours after the last dosing of oral semaglutide 25 mg on visit 8, day 84

Cmax

concentration, descriptive

Secondary/protocol endpoint

Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS)

Time frame:From 0 to 24 hours after the last dosing of oral semaglutide 50 mg on visit 10, day 112

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Time to maximum semaglutide plasma contraction at steady state (tmax,sema,SS)

Time frame:From 0 to 24 hours after the last dosing of oral semaglutide 25 mg on visit 8, day 84

Tmax

descriptive

Secondary/protocol endpoint

Time to maximum semaglutide plasma contraction at steady state (tmax,sema,SS)

Time frame:From 0 to 24 hours after the last dosing of oral semaglutide 50 mg on visit 10, day 112

Tmax

descriptive

Secondary/protocol endpoint

Number of treatment-emergent adverse events

Time frame:From the time of first dosing (visit 2, day 1) until completion of the follow-up visit (visit 11, day 149)

Treatment-emergent AEs (any)

event count, event

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.