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semaglutide glp 1 agonist rct n=27 2021-12-13 ClinicalTrials

Semaglutide Combination Investigated for Interaction with Oral Contraceptives

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

Background

Type 2 diabetes (T2D) is a chronic metabolic disorder requiring effective treatments, with semaglutide being a prominent GLP-1 receptor agonist. Novo Nordisk is developing a novel combination therapy of semaglutide with the investigational drug NNC0480-0389 to further improve blood sugar control. However, the potential for this new combination therapy to interact with the pharmacokinetics (how the body handles a drug) of commonly used oral medications, specifically oral contraceptives, was unknown.

Study Design

Population
27 healthy postmenopausal females.
Intervention
Co-administration of semaglutide and NNC0480-0389 (doses not specified, typically subcutaneous for semaglutide) with a single dose of an oral combination contraceptive containing ethinylestradiol and levonorgestrel.
Comparator
Pre/post administration of oral contraceptive components.
Outcome
The primary outcome was the assessment of whether the novel semaglutide and NNC0480-0389 combination therapy significantly altered the systemic exposure (AUC and Cmax) of ethinylestradiol and levonorgestrel.

This Phase 1 study enrolled 27 healthy postmenopausal females to investigate the drug-drug interaction potential. Participants received a single dose of an oral combination contraceptive containing ethinylestradiol and levonorgestrel. This was followed by co-administration with semaglutide and NNC0480-0389 (doses not specified, but typically administered subcutaneously for semaglutide). The study aimed to assess how the investigational combination therapy impacts the systemic exposure of the contraceptive components over a period from 2021-12-13 to 2022-09-01.

Results

The study systematically evaluated the pharmacokinetic parameters of ethinylestradiol and levonorgestrel when co-administered with semaglutide and NNC0480-0389. Key measurements included the AUC (area under the plasma concentration-time curve) and Cmax (maximum plasma concentration) for both contraceptive components. The investigation involved 27 healthy postmenopausal females. The primary finding was the assessment of whether the novel semaglutide and NNC0480-0389 combination therapy significantly altered the systemic exposure of ethinylestradiol and levonorgestrel. While specific quantitative results are not detailed in the summary, the study's completion indicates that data on these interactions were collected and analyzed. This data would inform whether dose adjustments for oral contraceptives might be necessary if co-prescribed with the new combination therapy.


semaglutide glp 1 agonist glp-1r protocol relevant safety data present
Source: clinicaltrials:NCT05153564 · Ingested 2026-05-12 · Digest: gemini-2.5-flash