GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets

A Comparative Bioavailability Trial of Steady State Semaglutide Exposure With the Current Formulation (Semaglutide) and a New Formulation (Semaglutide D) of Oral Semaglutide in Healthy Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

274

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-29.9•Healthy volunteers

Primary endpoint

•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 IDNCT04097600

Org study IDNN9924-4486

Secondary ID2019-000279-17European Medicines Agency (EudraCT)

Secondary IDU1111-1226-6257World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-09-20actual

Study start2019-09-30actual

Primary completion2020-12-16actual

Study completion2021-01-20actual

Last update posted2022-09-13actual

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 20.0 kg/m^2 and 29.9 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 haemoglobin (HbA1c) equal to or above 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 during the in-house period(s)

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

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

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

•History (as declared by the subject) or presence of pancreatitis (acute or chronic).

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

Time frame:From 0 to 24 hours after the last dosing of oral semaglutide low, medium and high dose on days 28, 56 and 84, respectively

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,sema,SS; maximum semaglutide plasma concentration at steady state

Time frame:From 0 to 24 hours after the last dosing of oral semaglutide low, medium and high dose on days 28, 56 and 84, respectively

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,sema,SS; time to maximum semaglutide plasma contraction at steady state

Time frame:From 0 to 24 hours after the last dosing of oral semaglutide low, medium and high dose on days 28, 56 and 84, respectively

Tmax

descriptive

Secondary/protocol endpoint

t½,sema,SS; terminal half-life of semaglutide at steady state

Time frame:Determined by concentrations measured between day 84 and follow-up at day 119 of semaglutide at steady state

Half-life

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.