DelfaGLP-1 Atlas

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CompletedPhase 1

Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects

An Open-label, One-sequence Cross Over, Single Centre Trial, Investigating the Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

24

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 23-30

Primary endpoints

•AUC of metformin•AUC of S-warfarin•AUC of R-warfarin

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 IDNCT02022254
Org study IDNN9535-3817
Secondary ID2012-005072-33
Secondary IDU1111-1136-6442WHO

Timeline

Milestones

Study start2013-12-17actual
Study first posted2013-12-27estimated
Primary completion2014-08-28actual
Study completion2014-08-28actual
Last update posted2017-04-04actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Male and female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
•Body mass index (BMI) between 23 and 30 kg/m^2 (both inclusive)

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearingpotential and not using adequate contraceptive methods for the duration of the trial and for 5 weeks following the last dose of semaglutide. Adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner
•Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
•Use of prescription or non-prescription systemic or topical medicinal products (including routine or non-routine vitamins or herbal products, but excluding paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2
•Smoking, drug or alcohol abuse

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 metformin plasma concentration-time curve

Time frame:During a dosing interval (0-12 hours) after the last of 7 repeated doses of metformin without semaglutide exposure (Day 4) and at semaglutide steady state (Day 104)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the S-warfarin plasma concentration-time curve

Time frame:From time 0 to 168 hours after a single dose of warfarin without semaglutide exposure (Day 11) and at semaglutide steady state (Day 111)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the R-warfarin plasma concentration-time curve

Time frame:From time 0 to 168 hours after a single dose of warfarin without semaglutide exposure (Day 11) and at semaglutide steady state (Day 111)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed metformin plasma concentration at steady state

Time frame:From dosing until 30 hours after the last of 7 repeated doses without semaglutide exposure and at semaglutide steady state (metformin administration on Days 4 and 104)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Maximum observed S-warfarin plasma concentration after single dose

Time frame:(0-168 hours) after a single dose of warfarin without semaglutide exposure and at semaglutide steady state (warfarin administrations on Days 11 and 111)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Maximum observed R-warfarin plasma concentration after single dose

Time frame:(0-168 hours) after a single dose of warfarin without semaglutide exposure and at semaglutide steady state (warfarin administrations on Days 11 and 110)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Incremental area under the INR (international normalised ratio) -curve

Time frame:From 0 to 168 hours

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.