GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Effect of Renal Impairment on the Pharmacokinetics of NN9535

An Open-label Trial Investigating the Pharmacokinetics and the Tolerability of NN9535 in Subjects With Normal Renal Function and Various Degrees of Impaired Renal Function

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criterion

•BMI ≤40

Primary endpoint

•AUC of NN9535

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 IDNCT00833716

Org study IDNN9535-3616

Timeline

Milestones

Study first posted2009-02-02estimated

Study start2009-02-02actual

Primary completion2010-07-26actual

Study completion2010-07-26actual

Last update posted2017-04-04actual

Assets

Investigational agents

Semaglutide

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

•Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)

•Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft \& Gault formula) for any of the renal function groups

•Body Mass Index (BMI) equal to or less than 40kg/m2

Exclusion criteria

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

•Renal transplanted patients

•Certain cardiac problems (heart failure, unstable angina, MI (myocardial infarction) within the last 3 months)

•Known current hepatic dysfunction or severe hepatic disease during the last 12 months

•Female of childbearing potential/breast feeding

•History of alcoholism or drug abuse

•Blood donation during the last 8 weeks prior to the study

•Past or current history of pancreatitis

Endpoints (2)

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

2 endpoints

Primary/protocol endpoint

AUC of NN9535

Time frame:at 21 days

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Laboratory safety, adverse events

Time frame:at 21 days

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

Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment.
Clinical pharmacokinetics2017 Nov (month)PMID28349386doi:10.1007/s40262-017-0528-2via CT.gov reference + pubmed nct search

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.