CompletedPhase 1

Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects

Lead sponsor

Novo Nordisk A/S

Asset

NNC0113-0987

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Type 2 diabetes

Eligibility highlights

•BMI ≤30•Male

Primary endpoint

•Number of treatment emergent adverse events (TEAEs)

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 IDNCT01690169

Org study IDNN9927-3909

Secondary ID2012-000047-27

Secondary IDU1111-1126-7584WHO

Timeline

Milestones

Study start2012-09-14actual

Study first posted2012-09-21estimated

Primary completion2012-12-11actual

Study completion2012-12-11actual

Last update posted2017-02-28actual

Assets

Investigational agents

NNC0113-0987

Who this study enrolls

Healthy volunteersType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age50 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood assessments at the screening visit

•Body mass index (BMI) above or equal to 18.5 and below 30 kg/m^ 2

Exclusion criteria

•Male subjects who are sexually active and not surgically sterilised, who or whose partner is unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g., condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 12 weeks following the last dose of trial medication

•Participation in another trial within 90 days prior to screening

•Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (including gastroesophageal reflux disease and irritable bowel syndrome), endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorders that might have an impact on the current trial, as judged by the investigator

•Subjects who are known to have hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for Human Immunodeficiency Virus (HIV) antibodies

•History of acute idiopathic or chronic pancreatitis

Endpoints (5)

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

5 endpoints

Primary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From the dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)

event count, event

Secondary/protocol endpoint

Number and severity of hypoglycaemic episodes

Time frame:From dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)

event count, event

Secondary/protocol endpoint

AUC, the area under the NNC0113-0987 plasma concentration-time curve

Time frame:From dosing visit to infinity

concentration, descriptive

Secondary/protocol endpoint

Cmax, the maximum plasma concentration of NNC0113-0987

Time frame:From dosing visit until last PK sampling visit (e.g. day 11)

concentration, descriptive

Secondary/protocol endpoint

tmax, the time to maximum plasma concentration of NNC0113-0987

Time frame:From dosing visit until last PK sampling visit (e.g. day 11)

time to event, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.