GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study Looking Into the Effect of NNC0519-0130 on Blood Levels of a Birth Control Pill and Emptying of the Stomach in Women After Menopause

Investigation of the Effect of NNC0519-0130 on the Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Healthy Postmenopausal Females

Lead sponsor

Novo Nordisk A/S

Asset

NNC0519-0130

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 27-39.9•Female

Primary endpoints

•AUC of ethinylestradiol during a dosing interval at steady state•AUC of levonorgestrel during a dosing interval at steady state•AUC of levonorgestrelduring a dosing interval 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 IDNCT06513104

Org study IDNN9541-4922

Secondary ID2023-507973-16European Medical Agency (EMA)

Secondary IDU1111-1294-3433World Health Organization (WHO)

Timeline

Milestones

Study start2024-07-18actual

Study first posted2024-07-22actual

Primary completion2025-09-10actual

Study completion2025-09-30actual

Last update posted2026-03-12actual

Assets

Investigational agents

NNC0519-0130

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Maximum age45 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•Postmenopausal female.

•Age greater than or equal to (≥)45 years at the time of signing informed consent.

•Body weight ≥ 60 kilogram (kg).

•Body mass index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

•Considered to be otherwise 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, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.

•Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimoles per mole (mmol/mol)) at screening.

•Any contraindications for the use of the oral contraception used in the study according to the Microgynon Summary of Product Characteristics, including:

1. Presence or risk of venous thromboembolism or arterial thromboembolism, e.g., history of migraine with focal neurological symptoms or transitory ischemic attacks.

2. Undiagnosed vaginal bleeding.

3. Presence or history of breast cancer.

4. Presence or history of liver tumours (benign or malignant).

5. Positive family history of arterial thromboembolism and/or venous thromboembolism (ever in a sibling or parent especially at relatively early age e.g. below 50).

6. Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and anti-phospholipid antibodies (anticardiolipinantibodies, lupus anticoagulant).

7. Known hereditary or acquired predisposition to venous thromboembolism, such as Activated Protein C (APC) resistance (including factor V Leiden), antithrombin III deficiency, protein C deficiency or protein S deficiency.

8. Dyslipoproteinaemia.

•Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic cytochrome P450 (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 screening 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 (9)

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

9 endpoints

Primary/protocol endpoint

Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state

Time frame:Day 8

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state

Time frame:Day 188

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the levonorgestrel plasma concentration time curve during a dosing interval at steady state

Time frame:Day 8

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area under the levonorgestrel plasma concentration time curveduring a dosing interval at steady state

Time frame:Day 188

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum ethinylestradiol plasma concentration at steady state

Time frame:Day 8 and Day 188

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Maximum levonorgestrel plasma concentration at steady state

Time frame:Day 8 and Day 188

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal

Time frame:Day 1 and Day 181

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal

Time frame:Day 1 and Day 181

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum paracetamol plasma concentration following a standardised meal

Time frame:Day 1 and Day 181

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.