DelfaGLP-1 Atlas

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CompletedPhase 1

Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects

An Open-label, One-sequence Cross Over, Single Centre Trial, Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

31

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 20-29.9

Primary endpoints

•AUC of atorvastatin•AUC of digoxin

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 IDNCT02243098
Org study IDNN9535-3818
Secondary ID2013-001288-22
Secondary IDU1111-1140-8551WHO

Timeline

Milestones

Study start2014-09-16actual
Study first posted2014-09-17estimated
Primary completion2015-04-07actual
Study completion2015-04-07actual
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 between 20.0 and 29.9 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 an adequate contraceptive method. Women of child-bearing potential must use an effective method of birth control throughout the trial including the 5 weeks follow-up period. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner
•Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, 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 supplements, but excluding paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2 (first dose administration)
•History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test
•History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units (male)/14 units (female) of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL spirits)
•Smoking in the last 3 months prior to screening or a positive nicotine test

Endpoints (5)

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

5 endpoints
Primary/protocol endpoint

Area under the atorvastatin plasma concentration-time curve

Time frame:From time 0 to 72 hours after a single dose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the digoxin plasma concentration-time curve

Time frame:From time 0 to 120 hours after a single dose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed atorvastatin plasma concentration

Time frame:From time 0 to 72 hours after a single dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Maximum observed digoxin plasma concentration

Time frame:From time 0 to 120 hours after a single dose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of treatment emergent AEs (TEAEs)

Time frame:From baseline (Visit 2, Day 1) to follow-up (Visit 12, 20 weeks after baseline)

Treatment-emergent AEs (any)

event count, event

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.