DelfaGLP-1 Atlas

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CompletedPhase 1

Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function

A Single-centre, Open-label, Trial Investigating the Pharmacokinetics and the Tolerability of Liraglutide in Subjects With Normal Renal Function and in Subjects With Impaired Renal Function

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

30

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criterion

—

Primary endpoint

•Area under the Curve (AUC)

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 IDNCT01508806
Org study IDNN2211-1329

Timeline

Milestones

Study first posted2012-01-12estimated
Last update posted2017-01-24estimated
Study start2005-08 (month precision)
Primary completion2006-03actual (month precision)
Study completion2006-03actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft and Gault formula) for any of the renal function groups
•Body Mass Index (BMI) maximum 40 kg/m^2

Exclusion criteria

•Known or suspected allergy to trial product(s) or related products
•Renal transplanted patients
•Haemodialysis patients
•Cardiac problems
•Uncontrolled treated/untreated hypertension
•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
•Excessive consumption of food deviating from a normal diet 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.

Coverage by outcome category

Safety / tolerability / PK
6
Renal / kidney
1

Renal / kidney

1 endpoint
Secondary/protocol endpoint

CLR (renal clearance)

descriptive

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

Area under the Curve (AUC)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

AUC (0-t)

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

t½, terminal half-life

Half-life

descriptive

Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

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.