CompletedPhase 1

Evaluation of Optimal Dosing Conditions for GLP-1 Analogue NNC0113-0987 When Administered Orally in Healthy Male Subjects

Lead sponsor

Novo Nordisk A/S

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Actual enrollment

122

Study population

Eligibility highlights

•BMI 18.5-29.9•Male

Primary endpoint

•AUC of NNC0113-0987

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 IDNCT02094521

Org study IDNN9926-4047

Secondary ID2012-003855-13

Secondary IDU1111-1133-7097WHO

Timeline

Milestones

Study first posted2014-03-24estimated

Last update posted2015-01-29estimated

Study start2014-03 (month precision)

Primary completion2014-07actual (month precision)

Study completion2014-07actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Male aged 18 between 55 years (both inclusive) at the time of signing informed consent

•Good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator

•Body mass index (BMI) between 18.5 and 29.9 kg/m^2 (both inclusive)

Exclusion criteria

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

•Blood pressure above 140 mmHg systolic and/or above 90 mmHg diastolic or pulse above 90 beats per minute at the screening visit

•Smoking more than 5 cigarettes or the equivalent per day (including use of nicotine substitute products)

•History of significant drug abuse, or a positive drug test at the screening visit

•Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding the screening visit

Endpoints (2)

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

2 endpoints

Primary/protocol endpoint

Area under the NNC0113-0987 plasma concentration time curve

Time frame:From time 0 to 24 hours after the 10th dosing

concentration, descriptive

Secondary/protocol endpoint

Maximum observed NNC0113-0987 plasma concentration

Time frame:0 to 24 hours after the 10th dosing

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.