DelfaGLP-1 Atlas

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CompletedPhase 1

A Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug in Healthy Postmenopausal Females

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

25

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-29.9•Female•Healthy volunteers

Primary endpoints

•AUC of ethinylestradiol during a dosing interval (0-24 hours) at steady state•AUC of levonorgestrel during a dosing interval (0-24 hours) at steady state

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 IDNCT02845219
Org study IDNN9924-4249
Secondary ID2015-004232-35
Secondary IDU1111-1174-7914WHO

Timeline

Milestones

Study first posted2016-07-27estimated
Last update posted2017-06-07actual
Study start2016-07 (month precision)
Primary completion2016-12actual (month precision)
Study completion2016-12actual (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age45 Years
SexFemale
Healthy volunteersAccepted

Inclusion criteria

•Postmenopausal female, age at least 45 years at the time of signing informed consent. With at least 12 consecutive months since the last spontaneous menstrual bleeding (if there was any uncertainty of the time of the last spontaneous bleeding, the postmenopausal status is to be confirmed with follicle stimulating hormone (FSH) 40 mIU/mL)
•Body mass index (BMI) between 20.0 and 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, electrocardiogram 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). A subject smoking less than one cigarette or the equivalent per day must be able or willing to refrain from smoking and use of nicotine substitute products during the trial
•Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening
•Sitting blood pressure at screening (after resting for at least 5 minutes) outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic. If white-coat hypertension is suspected a single repeat measurement is allowed, last measurement being conclusive
•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)

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 ethinylestradiol plasma concentration-time curve during a dosing interval (0-24 hours) at steady state

Time frame:On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state)

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the levonorgestrel plasma concentration-time curve during a dosing interval (0-24 hours) at steady state

Time frame:On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed ethinylestradiol plasma concentration during a dosing interval (0-24 hours) at steady state

Time frame:On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state)

Cmax

concentration, descriptive

Secondary/protocol endpoint

Maximum observed levonorgestrel plasma concentration during a dosing interval 0-24 hours) at steady state

Time frame:On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state)

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.