Skip to main content
OpenTrials
Completed

NCT Number: NCT05153564

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

Novo Nordisk is developing a combination therapy with the investigational drug NNC0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (T2D). It is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone. The study will investigate the influence of the combination of semaglutide and NNC0480-0389 on the blood levels of a birth control pill (a combined oral contraceptive consisting of ethinylestradiol and levonorgestrel) and paracetamol. Participants will get semaglutide and NNC0480-0389 as injection under the skin of their belly using a pen-injector. The injections will be given once weekly for 14 weeks. Additionally, participants will at two occasions get paracetamol as soluble tablet in connection with a standardised breakfast meal. Further, participants will get the birth control pill in form of tablets in two periods of 8 days each. Participants will get the combination of semaglutide and NNC0480-0389 as well as paracetamol and the combined contraceptive in any case. The study participation will last up to about 24 weeks. Participants will have 25 visits at the study centre. For 4 of the visits participants will stay at the study centre; the remaining visits will be outpatient. Only healthy postmenopausal women can take part in this study.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semaglutide 1.34 mg/mL

Drug

Semaglutide will be administered at a dose of 0.25, 0.50 or 1.0 mg as indicated on scale drum once weekly by subcutaneous (s.c.) (under the skin) injections in the abdomen for 14 weeks.

Semaglutide 3.0 mg/mL

Drug

Semaglutide will be administered at a dose of 2.0 mg corresponding to the increment of 67 (pen injector units) as indicated on scale drum. once weekly by subcutaneous (s.c.) (under the skin) injections in the abdomen for 14 weeks.

NNC0480-0389 10 mg/mL

Drug

NNC0480-0389 will be administered at a dose of 0.23, 0.45 or 0.90 mL once weekly by s.c. (under the skin) injections for 14 weeks.

NNC0480-0389 30 mg/mL

Drug

NNC0480-0389 will be administered at a dose of 0.60 mL once weekly by s.c. (under the skin) injections for 14 weeks.

Microgynon®

Drug

Microgyn® will be given as once daily oral dosing in two periods, each of 8 days' duration. One tablet contains levonorgestrel 0.15 mg and ethinylestradiol 0.03 mg.

Primary outcomes

  1. 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

    Measured in h*pg/mL

  2. 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

    Measured in h*pg/mL

Secondary outcomes

  1. 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

    Measured in pg/mL

  2. 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

    Measured in pg/mL

  3. 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

    Measured in h*μg/mL

  4. 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

    Measured in h*μg/mL

  5. 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

    Measured in μg/mL

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2021
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.