← Trials/Trial dossier/NCT01272973

CompletedPhase 1

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

96

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 21-30Male

Primary endpoint

Treatment-emergent AEs (any)

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 IDNCT01272973
Org study IDNN9924-3692
Secondary ID2010-019951-23
Secondary IDU1111-1118-0257Who

Timeline

Milestones

Study first posted2011-01-10estimated
Last update posted2015-02-23estimated
Study start2011-01 (month precision)
Primary completion2011-07actual (month precision)
Study completion2011-07actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

Healthy male subjects, based on an assessment of medical history, physical examination and
BMI between 21 and 30 kg/m2 (21 inclusive)

Exclusion criteria

Male subjects who are sexually active and unwilling to use a highly effective method of contraception for both them and their nonpregnant partner
Any clinically significant, abnormal disease history of the following systems: cardio-pulmonary, gastrointestinal, hepatic, neurological, renal,genitourinary, endocrine or haematological
The receipt of any investigational product within 90 days before screening, or is currently enrolled in any other clinical trial

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

Frequency of adverse events (AEs)

Time frame:from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Hypoglycaemic episodes

Time frame:from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose

event count, event

Secondary/protocol endpoint

Laboratory safety variables (haematology, biochemistry, and urinalysis)

Time frame:from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose

descriptive

Secondary/protocol endpoint

Maximum plasma concentration of NN9924

Time frame:after dosing on the 68th, 69th and 70th Day

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the plasma concentration curve over the dosing interval (0-24 hours)

Time frame:after dosing on the 68th, 69th and 70th day

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Terminal phase elimination half-life

Time frame:from last dose (day 70) to follow-up visit 91-105 days after first dose

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.