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

Last updated: April 15, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

1

Condition

Obesity

Hypertriglyceridemia

Treatment

Microgynon®

BI 456906

Clinical Study ID

NCT05896384
1404-0014
2022-503146-53-00
  • Ages 18-60
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Otherwise healthy women according to the assessment of the investigator, as based ona complete medical history including a physical examination, vital signs (bloodpressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinicallaboratory tests

  2. Age of 18 to 60 years (inclusive)

  3. Body mass index (BMI) of 27.0 to 40.0 kg/m2 (inclusive)

  4. Signed and dated written informed consent in accordance with International Councilfor Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior toadmission to the trial, i.e. prior to starting any screening procedures

  5. Subject fulfills any of the following criteria at least 4 weeks prior to allocationof subject number (i.e. prior to Day 1 of period 1):

  6. Use of non-hormone releasing intrauterine device (IUD) and male partner must bevasectomised (provided that partner is the sole sexual partner of the trialparticipant) with documented absence of sperm or use a condom

  7. Bilateral tubal ligation and male partner must be vasectomised (provided thatpartner is the sole sexual partner of the trial participant) with documentedabsence of sperm or use a condom

  8. Sexually abstinent (i.e. subjects must abstain from male-female sex)

  9. Surgically sterilised (including hysterectomy, bilateral salpingectomy,bilateral oophorectomy)

  10. Postmenopausal, defined as no menses for 1 year without an alternative medicalcause (in questionable cases a blood sample with levels of follicle stimulatinghormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion

Exclusion Criteria:

  1. Any finding in the medical examination (including BP, PR or ECG) deviating fromnormal and assessed as clinically relevant by the investigator

  2. Repeated measurement of systolic blood pressure outside the range of 90 to 140millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)

  3. Any laboratory value outside the reference range that the investigator considers tobe of clinical relevance and/or liver enzymes (alanine transaminase (ALT), aspartateaminotransferase (AST), gamma-glutamyl transpeptidase (GGT)) and/or pancreaticenzymes (amylase lipase) above upper limit of normal range +10% at screeningexamination, confirmed by a repeat test

  4. Any evidence of a concomitant disease assessed as clinically relevant by theinvestigator

  5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,immunological or hormonal disorders

  6. History of either chronic or acute pancreatitis

  7. Cholecystectomy, and/or prior surgery of the gastrointestinal (GI) tract (includingbariatric surgery) or any relevant anatomical malformation of the GI tract thatcould interfere with the pharmacokinetics of the trial medication (investigationalmedicinal product (IMP) or auxiliary medicinal product (AxMP)) - except appendectomyor simple hernia repair

  8. Diseases of the central nervous system (including but not limited to any kind ofseizures or stroke), and other relevant neurological or psychiatric disorders

  9. History of relevant orthostatic hypotension, fainting spells, or blackouts Furtherexclusion criteria apply

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: Microgynon®
Phase: 1
Study Start date:
December 21, 2023
Estimated Completion Date:
March 26, 2025

Connect with a study center

  • Charité Research Organisation GmbH

    Berlin, 10117
    Germany

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.