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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: NNC0519-0130; Drug: Levonorgestrel + Ethinylestradiol; Drug: Paracetamol

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Parexel International GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: NNC0519-0130; NNC0519-0130 will be administered subcutaneously.; Drug: Levonorgestrel + Ethinylestradiol; Levonorgestrel + Ethinylestradiol will be administered orally.; Drug: Paracetamol; Paracetamol will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state	Measured in hours picograms per milliliter (h*pg/mL).	Day 8
Area under the levonorgestrel plasma concentration time curve during a dosing interval at steady state	Measured in h*pg/mL.	Day 8
Area under the ethinylestradiol plasma concentration time curve during a dosing interval at steady state	Measured in h*pg/mL.	Day 188
Area under the levonorgestrel plasma concentration time curveduring a dosing interval at steady state	Measured in h*pg/mL.	Day 188

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum ethinylestradiol plasma concentration at steady state	Measured in picograms per milliliter (pg/mL).	Day 8 and Day 188
Maximum levonorgestrel plasma concentration at steady state	Measured in pg/mL.	Day 8 and Day 188
Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal	Measured in hours micrograms per milliliter (h*μg/mL).	Day 1 and Day 181
Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal	Measured in h*μg/mL.	Day 1 and Day 181
Maximum paracetamol plasma concentration following a standardised meal	Measured in micrograms per milliliter (μg/mL).	Day 1 and Day 181

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Actual): September 10, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Organic Chemicals; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Steroids; Fused-Ring Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Norpregnenes; Norpregnanes; Norsteroids; Norpregnatrienes; Estrogenic Steroids, Alkylated; Norgestrel; Acetaminophen; Levonorgestrel; Ethinyl Estradiol
• Other Study ID Numbers: NN9541-4922; U1111-1294-3433 (Other Identifier: World Health Organization (WHO)); 2023-507973-16 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No