CompletedPhase 1

Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy Subjects

Lead sponsor

Novo Nordisk A/S

Asset

NNC0113-0987

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

100

Study population

Diabetes (other / unspecified), Healthy volunteers

Eligibility highlights

•BMI 20-29.9•Male

Primary endpoint

•Number of treatment emergent adverse events recorded

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 IDNCT01978613

Org study IDNN9927-4022

Secondary ID2013-000188-10

Secondary IDU1111-1138-4595WHO

Timeline

Milestones

Study first posted2013-11-07estimated

Last update posted2014-06-30estimated

Study start2013-11 (month precision)

Primary completion2014-06actual (month precision)

Study completion2014-06actual (month precision)

Assets

Investigational agents

NNC0113-0987

Who this study enrolls

Diabetes (other / unspecified)Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexMale

Healthy volunteersNot accepted

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 and laboratory safety tests performed during the screening visit, as judged by the investigator

•Age 18-64 years (both inclusive) at the time of signing informed consent

•Body mass index (BMI): 20.0-29.9 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

•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

•History of chronic pancreatitis or idiopathic acute pancreatitis

•Subject with previous gastrointestinal surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy

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

Endpoints (4)

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

4 endpoints

Primary/protocol endpoint

Number of treatment emergent adverse events recorded

Time frame:From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)

event count, event

Secondary/protocol endpoint

Number of hypoglycaemic episodes

Time frame:From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)

event count, event

Secondary/protocol endpoint

Area under the NNC0113-0987 plasma concentration time curve

Time frame:During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69)

concentration, descriptive

Secondary/protocol endpoint

Maximum observed NNC0113-0987 plasma concentration

Time frame:During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69)

concentration, descriptive

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.