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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-11-13

No results posted yet for this study

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

Interventions

DRUG

Semaglutide 1.34 mg/mL

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.

DRUG

Semaglutide 3.0 mg/mL

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.

DRUG

NNC0480-0389 10 mg/mL

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.

DRUG

NNC0480-0389 30 mg/mL

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

DRUG

Microgynon®

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency dept. 1452 · Novo Nordisk A/S

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-13
Primary Completion
2022-08-13
Completion
2022-09-01

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05153564 on ClinicalTrials.gov