DelfaGLP-1 Atlas

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CompletedPhase 1

Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men

A Trial Comparing Exposure of Semaglutide When Dosing New Formulations of Oral Semaglutide to Healthy Male Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

105

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-29.9•Male•Healthy volunteers

Primary endpoint

•AUC0-24h,sema,day10, AUC of semaglutide from 0

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 IDNCT03638778
Org study IDNN9924-4427
Secondary ID2017-005023-24European Medicines Agency (EudraCT)
Secondary IDU1111-1206-6210World Health Organization (WHO)

Timeline

Milestones

Study start2018-08-17actual
Study first posted2018-08-20actual
Primary completion2018-12-05actual
Study completion2018-12-05actual
Last update posted2019-11-14actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexMale
Healthy volunteersAccepted

Eligibility criteria

•Male, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 20.0 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) greater than or equal to 6.5% (48 mmol/mol) at screening. - Use of tobacco and nicotine products, defined as any of the below:
a)Smoking more than 5 cigarettes or the equivalent per day.
b)Not willing to refrain from smoking and use of nicotine substitute products during the in-house period(s). - 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). - 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*. - History* or presence of pancreatitis (acute or chronic). *As declared by subject.

Endpoints (6)

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

6 endpoints
Primary/protocol endpoint

AUC0-24h,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 24 hours after the 10th dosing

Time frame:0 to 24 hours on day 10

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,sema,day10, maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing

Time frame:0 to 24 hours on day 10

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,sema,day10, time to maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing

Time frame:0 to 24 hours on day 10

Tmax

descriptive

Secondary/protocol endpoint

AUC0-30min,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 30 minutes after the 10th dosing

Time frame:0 to 30 minutes on day 10

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

t½,sema,day10, terminal half-life of semaglutide up to 35 days after the 10th dosing

Time frame:Days 10-45

Half-life

descriptive

Secondary/protocol endpoint

Number of treatment emergent adverse events

Time frame:Days 1-47

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.