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

NCT ID: NCT06513104

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-18
• Study Completion Date: 2025-09-30

Brief Summary

The purpose of the study is to investigate if NNC0519-0130 affects the blood levels of a birth control pill that contains the two hormones ethinylestradiol and levonorgestrel. The study will also look into if NNC0519-0130 affects how fast stomach is emptied. Participants will get the new study medicine NNC0519-0130 and will also get birth control pills and paracetamol. The study will last for about 35 weeks.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NNC0519-0130 + OC+ paracetamol

All participants will initiate treatment with paracetamol (once) and oral contraceptive (Levonorgestrel + Ethinylestradiol) treatment only followed by a period with NNC0519-0130 treatment only, thereafter a period with NNC0519-0130, paracetamol (once) and oral contraceptive treatment.

Group Type: EXPERIMENTAL

NNC0519-0130

Intervention Type: DRUG

NNC0519-0130 will be administered subcutaneously.

Levonorgestrel + Ethinylestradiol

Intervention Type: DRUG

Levonorgestrel + Ethinylestradiol will be administered orally.

Paracetamol

Intervention Type: DRUG

Paracetamol will be administered orally.

Interventions

NNC0519-0130

NNC0519-0130 will be administered subcutaneously.

Intervention Type: DRUG

Levonorgestrel + Ethinylestradiol

Levonorgestrel + Ethinylestradiol will be administered orally.

Intervention Type: DRUG

Paracetamol

Paracetamol will be administered orally.

Intervention Type: DRUG

Eligibility Criteria

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.

• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Parexel International GmbH

Berlin, , Germany

Countries

Germany

Other Identifiers

U1111-1294-3433

Identifier Type: OTHER

Identifier Source: secondary_id

2023-507973-16

Identifier Type: OTHER

Identifier Source: secondary_id

NN9541-4922

Identifier Type: -

Identifier Source: org_study_id