← Trials/Trial dossier/NCT00983021

CompletedPhase 1

Safety and Tolerability of NN9068 in Healthy Male Volunteers

A Trial to Test for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9068 and Compared With NN1250 and NN2211 in Healthy Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

24

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 18-27Male

Primary endpoint

Number and severity of adverse events, number (Treatment-emergent AEs (any), Documented hypoglycemia)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00983021
Org study IDNN9068-3632
Secondary ID2009-011269-95
Secondary IDU1111-1111-8859WHO

Timeline

Milestones

Study first posted2009-09-23estimated
Last update posted2017-02-08estimated
Study start2009-09 (month precision)
Primary completion2009-12actual (month precision)
Study completion2009-12actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

Male subjects, who are considered to be generally healthy, based on an assessment of medical history, physical examination, and clinical laboratory data, as judged by the Investigator.
Body mass index (BMI) between 18.0 and 27.0 kg/m2 (both inclusive)
Body weight between 60 kg and 90 kg (both inclusive)

Exclusion criteria

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

Endpoints (3)

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

3 endpoints
Primary/protocol endpoint

Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes

Time frame:assessed 0-96 hours after trial product administration

descriptive

componentsTreatment-emergent AEs (any), Documented hypoglycemia

Secondary/protocol endpoint

The area under the NN2211 concentration-time curve after single-dose

Time frame:assessed 0-72 hours after trial product administration

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

The area under the NN1250 concentration-time curve after single-dose

Time frame:assessed 0-96 hours after trial product administration

AUC₀–∞

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.