CompletedPhase 1

Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

170

Study population

Healthy volunteers

Eligibility highlights

•BMI 20-30•HbA1c ≤6%•Male•Healthy volunteers

Primary endpoint

•Treatment-emergent AEs (any)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01866748

Org study IDNN9928-4048

Secondary ID2012-003199-38

Secondary IDU1111-1132-4190WHO

Timeline

Milestones

Study first posted2013-05-31estimated

Last update posted2014-04-28estimated

Study start2013-05 (month precision)

Primary completion2014-04actual (month precision)

Study completion2014-04actual (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator

•Body Mass Index (BMI) between 20 and 30 kg/m^2

•Glycosylated haemoglobin (HbA1c) below 6.0% (only in Part B)

Exclusion criteria

•History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (GI), endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator

•Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing. Occasional use of paracetamol or acetylsalicylic acid is permitted

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.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

Glycemic / diabetes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Part B: Change in body weight from baseline

Time frame:Day -1, day 70

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Part B: Change in fasting plasma glucose (FPG) from baseline

Time frame:Day 0 (pre-dose), day 70

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Part A: Number of treatment emergent adverse events (TEAEs)

Time frame:Day -1 to Day 24

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Part B: Number of treatment emergent adverse events (TEAEs)

Time frame:Recorded from the time of first dosing (Visit 3, Day -1 to day +2) and until completion of the post treatment follow-up visit (Visit 18, Day 90-104)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Part A: AUC0-24h,semaglutide: the area under the semaglutide plasma concentration curve

Time frame:From time 0 to 24 hours after a single dose (Day 0)

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Part B: AUCτ,semaglutide: area under the semaglutide plasma concentration curve

Time frame:Over the dosing interval (0-24 hours) after the last 3 daily doses (Days 67-69)

AUC₀-∞

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.