DelfaGLP-1 Atlas

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CompletedPhase 1

Effect of Liraglutide on Heart Frequency in Healthy Volunteers

A Thorough QTc Evaluation of the Effect of Liraglutide on Cardiac Repolarization in Healthy Volunteers: A Randomized, Double-blind, Placebo-controlled, Two Period Crossover Study Followed by Open-label Moxifloxacin (Positive Control) Administration

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

64

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-29•Healthy volunteers

Primary endpoint

•Maximum time-matched mean difference between the baseline subtracted QTci

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 IDNCT01516255
Org study IDNN2211-1644

Timeline

Milestones

Study first posted2012-01-24estimated
Last update posted2017-01-25estimated
Study start2006-07 (month precision)
Primary completion2006-11actual (month precision)
Study completion2006-11actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Healthy
•Fasting plasma glucose within normal limits (80-100 mg/dl)
•BMI (Body Mass Index): 20.0-29.0 kg/m^2 (inclusive)
•Heart rate within the range of 50-90 beats per minute (inclusive)
•Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data

Exclusion criteria

•Any clinically significant disease history, in the opinion of the investigator, of systemic or organ disease
•Any clinically significant disease history, in the opinion of the investigator, of cardiovascular disease
•Clinically significant abnormalities on any pre-study clinical examination or any abnormal laboratory measurements during screening
•A family history of sudden cardiac death at age less than 50 years old
•T-wave abnormalities
•Individual or familial history of long QT Syndrome
•Positive results on Screening for Hepatitis B surface antigen, Hepatitis C antibody or HIV (human immunodeficiency virus) antibody
•Positive results on the urine drug and alcohol screen
•Any regular use of prescription or nonprescription drugs or vitamins and herbal/nutritional supplements that cannot be stopped at screening
•Any strenuous exercise (as judged by the investigator) from 4 days prior to randomisation and during the entire trial period
•Blood donation, trauma or surgery with blood loss exceeding 500 ml within the last 2 months prior to dosing
•Subject is a smoker, occasional smoker or has a history of smoking (or use of any tobacco) within the last 3 months
•Excessive use of methylxanthine-containing beverages (more than 8 cups/day of coffee, tea, soda or chocolate)
•Females who are pregnant, breastfeeding, intend to become pregnant within the next 3 months, or who are judged to be using inadequate contraceptive measures
•A history (within the last 2 years) of drug or alcohol abuse

Endpoints (9)

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
7
Cardiometabolic biomarkers
2

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Vitals signs: Blood pressure

descriptive

Secondary/protocol endpoint

Vital signs: Pulse

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

7 endpoints
Primary/protocol endpoint

Maximum time-matched mean difference between the baseline subtracted QTci intervals

change from baseline, descriptive

Secondary/protocol endpoint

QTc at liraglutide tmax (time to reach maximum concentration)

descriptive

Secondary/protocol endpoint

Percentage subjects with QTc at least 450, 480 and 500 milliseconds

threshold achievement, event

Secondary/protocol endpoint

Moxifloxacin maximum time-matched mean change QTc and QTci

change from baseline, descriptive

Secondary/protocol endpoint

Cmax, maximum concentration of liraglutide

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, time to reach Cmax of liraglutide

Tmax

descriptive

Secondary/protocol endpoint

Serial electrocardiography

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.