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

NCT05153564 | Completed Phase 1

• 3 other identifiers: NN9389-46812021-003060-27U1111-1266-3910
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

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

  Measured in h\*pg/mL

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

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

  Measured in h\*pg/mL

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

Secondary Outcomes (5)

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

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

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

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

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

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

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

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

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

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

Study Arms (1)

One-sequence cross-over arm

EXPERIMENTAL

Drug: Semaglutide 1.34 mg/mL; Drug: Semaglutide 3.0 mg/mL; Drug: NNC0480-0389 10 mg/mL; Drug: NNC0480-0389 30 mg/mL; Drug: Microgynon®

Interventions

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.

One-sequence cross-over arm

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.

One-sequence cross-over arm

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.

One-sequence cross-over arm

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.

One-sequence cross-over arm

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.

One-sequence cross-over arm

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide; ethinyl estradiol, levonorgestrel drug combination

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 1452

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 10, 2021
• Study Start: December 13, 2021
• Primary Completion: August 13, 2022
• Study Completion: September 1, 2022
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)