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

Sponsor
Novo Nordisk A/S
Study ID
NCT05153564
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 13, 2021
Status verified
Nov 2023
Primary completion
Aug 13, 2022
Completion
Sep 1, 2022

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: One-sequence cross-over arm

Primary Outcome Measure

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 ]

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