DelfaGLP-1 Atlas

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CompletedPhase 1

Investigation of Optimal Dosing Conditions for a Long Acting GLP-1 Analogue in Healthy Male Subjects

A Single Centre, Multiple Dose, Open Label Randomised Trial to Evaluate the Effect of Post Dose Meal Timings and the Effect of Volume of Water With Dosing on the Pharmacokinetic Properties of Oral Semaglutide in Healthy Male Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

161

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 18.5-30•Male

Primary endpoint

•AUC 0-24h

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 IDNCT01572753
Org study IDNN9924-3794
Secondary ID2010-019653-17
Secondary IDU1111-1120-6776WHO

Timeline

Milestones

Study first posted2012-04-06estimated
Study start2012-04-12actual
Primary completion2012-09-08actual
Study completion2012-09-08actual
Last update posted2017-02-27actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

•Good general health as judged by the investigator, based on medical history, physical examination, electrocardiogram (ECG), vital signs and clinical laboratory
•Body mass index (BMI) of 18.5-30.0 kg/m^2 (both inclusive)

Exclusion criteria

•Males who are sexually active and not surgically sterilised, who or whose partner(s): a. are not using adequate contraceptive methods (e.g. condom with spermicidal foam/gel/film/cream or contraceptives with a Pearl Index below 1%, such as implants, injectables, combined oral contraceptives, or hormonal intrauterine devices or diaphragm + spermicide) or b. do not refrain from sexual intercourse during the trial and until 30 days following the last dose of trial medication. In addition, subjects must not donate sperm for the duration of the trial and for 30 days following the last dose of trial medication or c. sterilization of either partner
•Suffer from a life threatening disease or has a history of any clinically significant disease or disorder
•History of acute idiopathic or chronic pancreatitis
•Calcitonin value equal to or above 50 ng/L
•Any clinically significant abnormal laboratory test results (haematology, biochemistry and urinalysis), as judged by the investigator and any of the following laboratory safety results (based on screening results): Amylase, lipase and creatinine, above upper normal range. Aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and gamma-glutamyl-transpeptidase (gamma-GT) above 1.5 times upper normal range (UNR). Thrombocytes below 0.75 times lower normal range (LNR) or above 1.25 times UNR. Leucocytes outside 3.0 to 11.0x10^9/L (normal range is 3.91 to 8.77x10^9/L. Sodium outside the range 130.0 to 150.0 mmol/L (normal range is 136-145 mmol/L). Potassium outside the range 3.0 to 5.5 mmol/L (normal range is 3.5 to 5.1 mmol/L)
•Any clinically significant abnormal ECG, as judged by the investigator
•Subjects who are smokers

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

AUC 0-24h; Area under the semaglutide concentration curve from time 0-24 hours after the 10th dosing

Time frame:0-24hrs after the 10th dosing

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax; The maximum plasma semaglutide concentration

Time frame:Post-dose at day 10

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax; Time to maximum plasma semaglutide concentration

Time frame:Post-dose at day 10

Tmax

descriptive

Secondary/protocol endpoint

t1/2; the terminal half-life of semaglutide

Time frame:Post-dose at day 10

Half-life

descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.