CompletedPhase 1

Comparison of Liraglutide Inhaled Into the Lungs Compared to Liraglutide Injected Under the Skin in Healthy Male Volunteers

A Single-Centre, Open-Label, Five-Period Crossover Trial In Healthy Male Volunteers Investigating the Relative Bioavailability of NNC 90-1170 By Pulmonary Administration Compared To A Subcutaneous Injection

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Inhaled · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 20-30•Male

Primary endpoint

•Ratio of the areas under the plasma NN 90-1170 curves

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 IDNCT01511159

Org study IDNN2211-1464

Timeline

Milestones

Study first posted2012-01-18estimated

Last update posted2015-03-26estimated

Study start2001-10 (month precision)

Primary completion2001-12actual (month precision)

Study completion2001-12actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexMale

Healthy volunteersNot accepted

Inclusion criteria

•No clinically important abnormal physical findings

•No clinically relevant abnormalities in the results of laboratory screening evaluation

•Normal (or abnormal but not clinically significant) ECG (electrocardiogram)

•Normal (or abnormal but not clinically significant) blood pressure and heart rate

•Body Mass Index (BMI) between 20-30 kg/m^2 or outwith range but not clinically significant

•Non-smoker

•Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) at least 85% of predicted normal for age, gender and height

•FVC ratio at least 75% of predicted normal for age, gender and height

Exclusion criteria

•A clinically significant illness or infection requiring treatment within the last two months

•Any infection involving the respiratory system or adverse event that may, in the opinion of the principal investigator, interfere with blood glucose homeostasis

•Subjects with first and/or second degree relative(s) with diabetes mellitus

•Donation or loss of greater than 500 ml of blood in the period 0-12 weeks before trial entry

•Alcohol use in excess of 28 units of alcohol per week. A unit of alcohol is equivalent to half a pint of average strength beer, a glass (125 ml) of wine or a pub measure (25 ml) of spirits, sherry or port

•Current addiction to alcohol or substances of abuse

•Females

•Presence of hepatitis B surface antigen, hepatitis C antibody or HIV (human immunodeficiency virus) 1 or 2 antibodies

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.

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

Ratio of the areas under the plasma NN 90-1170 curves

ratio, descriptive

Secondary/protocol endpoint

The maximum concentration (Cmax)

Cmax

concentration, descriptive

Secondary/protocol endpoint

The time to maximum concentration (tmax)

Tmax

descriptive

Secondary/protocol endpoint

Mean residence time (MRT)

descriptive

Secondary/protocol endpoint

Area under the curve

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Terminal rate constant

descriptive

Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive

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.