GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study Looking Into the Effect of Semaglutide and NNC0480 0389 on Blood Levels of a Birth Control Pill in Woman After Menopause

Investigation of the Effect of Subcutaneously Co-administered Semaglutide and NNC0480-0389 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) in Healthy Postmenopausal Females

Lead sponsor

Novo Nordisk A/S

Assets

NNC0480-0389 / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

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•AUC of levonorgestrel during a dosing interval

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 IDNCT05153564

Org study IDNN9389-4681

Secondary ID2021-003060-27

Secondary IDU1111-1266-3910WHO

Timeline

Milestones

Study first posted2021-12-10actual

Study start2021-12-13actual

Primary completion2022-08-13actual

Study completion2022-09-01actual

Last update posted2023-11-13actual

Assets

Investigational agents

NNC0480-0389 Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age45 Years

SexFemale

Healthy volunteersAccepted

Inclusion criteria

•Postmenopausal female, aged greater than or equal to 45 years at the time of signing informed consent

•Body mass index between 20.0 and 29.9 kilogram per meter square (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

•Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol

•HbA1c greater than or equal to 6.5 % (48 millimoles per mole (mmol/mol)) at screening

•Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic cytochrome P450 enzyme (CYP) pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are routine vitamins, occasional use of paracetamol, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation

•Use of hormone replacement therapy within 4 weeks before first dose of trial product or intention to initiate treatment with hormone replacement therapy during the study

•Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions

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 ethinylestradiol plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,EE,SS)

Time frame:From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the levonorgestrel plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,LN,SS)

Time frame:From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum concentration of ethinylestradiol at steady state (Cmax,EE,SS)

Time frame:Within pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100

Cmax

concentration, descriptive

Secondary/protocol endpoint

Maximum concentration of levonorgestrel at steady state (Cmax,LN,SS)

Time frame:Within pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal (AUC0-60min,para)

Time frame:From pre-dose to 60 minutes after dosing of paracetamol on day 1 and day 93

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal (AUC0-300min,para)

Time frame:From pre-dose to 300 minutes after dosing of paracetamol on day 1 and day 93

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum observed paracetamol concentration following a standardised meal (Cmax,para)

Time frame:Within pre-dose to 300 minutes after dosing of paracetamol on day 1 and day 93

Cmax

concentration, descriptive

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.