CompletedPhase 1

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male Subjects

Lead sponsor

Novo Nordisk A/S

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI 20-29.9•Male•Healthy volunteers

Primary endpoint

•Number of treatment emergent adverse events (TEAEs) 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 IDNCT01967589

Org study IDNN9926-3950

Secondary ID2012-002893-30

Secondary IDU1111-1131-8724WHO

Timeline

Milestones

Study first posted2013-10-23estimated

Last update posted2014-06-20estimated

Study start2013-10 (month precision)

Primary completion2014-05actual (month precision)

Study completion2014-05actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Male, who is considered to be generally healthy, based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) 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

•BMI (body mass index) 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 (GI), 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 type 2

•History of chronic pancreatitis or idiopathic acute pancreatitis

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

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

Endpoints (7)

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.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline (Day -1) to after 10 weeks of treatment (Day 70)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)

change from baseline, improvement

Secondary/protocol endpoint

Change in HbA1C (glycosylated haemoglobin)

Time frame:From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Number of treatment emergent adverse events (TEAEs) 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

Area under the NNC0113-0987 plasma concentration 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

Secondary/protocol endpoint

Time to 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)

time to event, event

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.