CompletedPhase 1

Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects

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

Lead sponsor

Novo Nordisk A/S

Asset

NNC0113-0987

Intravenous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

101

Study population

Healthy volunteers, Type 2 diabetes

Eligibility highlights

•BMI ≤30•Male

Primary endpoint

•Overview of Treatment Emergent Adverse Events (AEs)

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 IDNCT01405261

Org study IDNN9926-3894

Secondary ID2011-000297-57

Secondary IDU1111-1119-1560WHO

Timeline

Milestones

Study first posted2011-07-29estimated

Last update posted2013-11-28estimated

Study start2011-08 (month precision)

Primary completion2012-05actual (month precision)

Study completion2012-05actual (month precision)

Assets

Investigational agents

NNC0113-0987

Who this study enrolls

Healthy volunteersType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age50 Years

SexMale

Healthy volunteersNot accepted

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 and urinary laboratory assessments at the screening visit

•Body Mass Index (BMI) of minimum 18.5 and below 30 kg/m^2

Exclusion criteria

•Male subjects who are sexually active and not surgically sterilised, who or whose partner are 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 3 months following the last dose of trial medication

•The receipt of any investigational product within 90 days (or 5 half-lives of investigational drug, whichever is greater) prior to this trial (screening), or is currently enrolled in any other clinical trial

•Subjects with a 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 that might have 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 chronic or idiopathic acute pancreatitis or amylase or lipase values above 3x upper normal range (UNR)

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

Overview of Treatment Emergent Adverse Events (AEs)

Time frame:Up to 25 days after trial product administration

descriptive

Secondary/protocol endpoint

Frequency of hypoglycaemic episodes

Time frame:From screening (day 1-21 before trial product administration) and until completion of the post treatment follow-up visit (day 12-25 after trial product administration)

event count, event

Secondary/protocol endpoint

AUC0-240h; area under the NNC 0113-0987 concentration-time curve

Time frame:From time 0 to 240 hours after a single oral or intravenous (i.v.) dose

concentration, descriptive

Secondary/protocol endpoint

AUC, area under the curve

Time frame:From time 0 to infinity after a single oral or i.v. dose

concentration, descriptive

Secondary/protocol endpoint

Cmax; maximum concentration of NNC 0113-0987 in plasma

Time frame:After a single oral or i.v. dose

concentration, descriptive

Secondary/protocol endpoint

The time to maximum concentration (tmax) of NNC 0113-0987 in plasma

Time frame:After a single oral dose

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.