NCT05896384

A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Blood

A Non-randomised, Open-label Phase I Trial to Evaluate the Effect of BI 456906 at Different Dose Levels of Multiple Subcutaneous Doses in a Titration Scheme on the Single Dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Otherwise Healthy Women With Overweight/Obesity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is open to women with overweight or obesity who are otherwise healthy. Women with a body mass index (BMI) from 27 to 40 kg/m2 can participate. The purpose of this study is to find out whether taking multiple doses of BI 456906 influences the amount of ethinylestradiol and levonorgestrel in the blood. Ethinylestradiol and levonorgestrel are ingredients of the contraceptive Microgynon®. The study has 2 treatment periods. In Period 1, participants get 1 tablet of Microgynon®. In Period 2, participants get weekly injections of BI 456906 for 7 months. The doses of BI 456906 increase each month. At 8 specific timepoints during Period 2, participants also get 1 tablet of Microgynon®. Participants visit the study site up to 40 times. At 8 visits, participants take Microgynon® and stay overnight at the site. During the visits, the doctors collect information about participants' health and take blood samples from the participants. They compare the amount of ethinylestradiol and levonorgestrel in the blood in Period 2 with the amounts in Period 1. Doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 456906	BI 456906
DRUG	Microgynon®	Ethinylestradiol (EE) and Levonorgestrel (LNG)

Timeline

• Start date: 2023-12-21
• Primary completion: 2025-02-14
• Completion: 2025-03-26
• First posted: 2023-06-09
• Last updated: 2025-04-16

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study