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CompletedPhase 1

Effect of Liraglutide on Gastrointestinal Absorption of Several Drugs and Potential Influence of Liraglutide on Intragastric pH

A Two-way Cross-over, Placebo-controlled Interaction Trial in Two Parts (in Healthy Subjects), Studying Liraglutide's Potential Influence on the Absorption Pharmacokinetics of Lisinopril, Atorvastatin, Griseofulvin and Digoxin, and Liraglutide's Potential Influence on Intragastric pH

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

70

Study population

Healthy volunteers

Eligibility highlights

•BMI 18-30

Primary endpoints

•Area under the curve of atorvastatin•Area under the curve of lisinopril•Area under the curve of griseofulvin

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 IDNCT01518166
Org study IDNN2211-1608
Secondary ID2006-000175-15

Timeline

Milestones

Study first posted2012-01-25estimated
Last update posted2017-01-25estimated
Study start2006-05 (month precision)
Primary completion2007-04actual (month precision)
Study completion2007-04actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Female subjects if using adequate anti-contraception or is sterile
•Body Mass Index (BMI) of 18-30 kg/m^2 (both inclusive)
•Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments
•Willing and capable to self-administer a subcutaneous injection

Exclusion criteria

•History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator
•Impaired renal function
•Blood pressure and heart rate in supine position outside the ranges 90-140 mmHg systolic, 50-90 mmHg diastolic and heart rate 40-100 beats/min
•Any clinically significant abnormal ECG
•Active hepatitis B and/or active hepatitis C
•Positive HIV (human immunodeficiency virus) antibodies
•Known or suspected allergy to trial product(s) or related products
•Use of any prescription or non-prescription medication except for paracetamol, nasal spray or drops for nasal congestion, and vitamins within 2 weeks prior to first dosing and during the entire trial period
•History of alcoholism or drug abuse during the last 12 months
•Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
•Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator

Endpoints (10)

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
9
Other clinical outcomes
1

Safety / tolerability / PK

9 endpoints
Primary/protocol endpoint

Area under the curve of atorvastatin

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Area under the curve of lisinopril

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Area under the curve of griseofulvin

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Area under the curve of digoxin

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Area under the curve of liraglutide

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Cmax, maximum concentration

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, time to reach Cmax

Tmax

descriptive

Secondary/protocol endpoint

Terminal elimination rate constant

descriptive

Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Intragastric pH

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 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.