DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT02014259

CompletedPhase 1

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function

Investigation of Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

4

Recruiting sites

—

Enrollment

71

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criterion

•BMI 18.5-40

Primary endpoint

•AUC of semaglutide

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 IDNCT02014259
Org study IDNN9924-4079
Secondary ID2013-000682-36
Secondary IDU1111-1139-4281WHO

Timeline

Milestones

Study start2013-12-11actual
Study first posted2013-12-18estimated
Primary completion2014-10-24actual
Study completion2014-10-24actual
Last update posted2018-04-19actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age85 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Male or female aged 18-85 years (both inclusive) at the time of signing inform consent
•Subject with normal renal function or renal impairment (mild, moderate, severe or end-stage renal disease requiring dialysis)
•For subject with normal renal function: good general health (as judged by the investigator)
•Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive)

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
•History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
•Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
•Any blood draw or donation of blood or plasma in excess of 400 mL within the 3 months preceding the screening visit (Visit 2)
•History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)

Endpoints (4)

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

4 endpoints
Primary/protocol endpoint

Area under the semaglutide plasma concentration time curve

Time frame:From time 0 to 24 hours after the 10th dosing

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed semaglutide plasma concentration

Time frame:0 to 24 hours after the 10th dosing

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve

Time frame:From time 0 to 24 hours after the 10th dosing

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed SNAC plasma concentration

Time frame:0 to 24 hours after the 10th dosing

Cmax

concentration, descriptive

Publications (2)

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.