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CompletedPhase 1

A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects

A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects.

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

41

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 20-29.9Healthy volunteers

Primary endpoints

AUC of furosemideAUC of rosuvastatin

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 IDNCT03010475
Org study IDNN9924-4250
Secondary ID2015-003908-23
Secondary IDU1111-1173-8618UTN

Timeline

Milestones

Study first posted2017-01-05estimated
Study start2017-01-05actual
Primary completion2017-06-04actual
Study completion2017-08-09actual
Last update posted2017-12-20actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
Body mass index (BMI) between 20.0-29.9 kg/m^2 (both inclusive)
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiography and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion criteria

Smoker (defined as a subject who is smoking at least one cigarette or the equivalent per day)
Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
Have personal or family history of myopathy
Previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate
Thyroid-Stimulating Hormone outside lower limit of normal minus 10 percent and upper limit of normal plus 10 percent
Creatine kinase above 5 x upper limit of normal
Asian subject

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 furosemide plasma concentration-time curve

Time frame:day 1, day 7, day 54

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the rosuvastatin plasma concentration-time curve

Time frame:day 2, day 8, day 55

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed furosemide plasma concentration

Time frame:day 1, day 7, day 54

Cmax

concentration, descriptive

Secondary/protocol endpoint

Maximum observed rosuvastatin plasma concentration

Time frame:day 2, day 8, day 55

Cmax

concentration, 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.