GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Comparison of Two Liraglutide Formulations in Healthy Subjects

A Randomized, Double-blind, Single-centre, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between the Phase 2 Formulation of Liraglutide at pH 7.7 (Formulation 3) and the Phase 3 Formulation at pH 8.15 (Formulation 4)

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 18-27

Primary endpoints

•Area under the curve (0-t)•Cmax, Cmax

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 IDNCT01515579

Org study IDNN2211-1693

Secondary ID2005-005948-68

Timeline

Milestones

Study first posted2012-01-24estimated

Last update posted2015-01-30estimated

Study start2006-04 (month precision)

Primary completion2006-06actual (month precision)

Study completion2006-06actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

•BMI (Body Mass Index) of 18.0-27.0 kg/m^2, both inclusive

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

•Any clinically significant abnormal ECG, as judged by the Investigator

•Active hepatitis B and/or active hepatitis C

•Positive human immunodeficiency virus (HIV) antibodies

•Known or suspected allergy to trial product(s) or related products

•Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures

•Use of any prescription or non-prescription medication, except for paracetamol and vitamins, as judged by the Investigator

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

Area under the curve (0-t)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cmax, maximum concentration

Cmax

concentration, descriptive

Secondary/protocol endpoint/low confidence

Area under the curve

concentration, descriptive

Secondary/protocol endpoint

tmax, time to reach Cmax

Tmax

descriptive

Secondary/protocol endpoint

t½, terminal half-life

Half-life

descriptive

Secondary/protocol endpoint

Terminal elimination rate constant

descriptive

Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive, event

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.