A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems

Launched by BOEHRINGER INGELHEIM · Apr 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called BI 456906 is absorbed into the bloodstream of adults, both with and without kidney problems. The goal is to see if kidney issues affect how much of this drug enters the blood, which is important because BI 456906 is being developed to help treat obesity and liver problems—conditions that often come with kidney issues. To participate, individuals must be between 18 and 80 years old, have a body mass index (BMI) between 20 and 40, and provide written consent to join the study.

Participants will receive a single injection of BI 456906 and will be monitored closely for about two months. They will spend five days and four nights at the study site and will have around seven visits with their doctors during this time. These visits will involve health check-ups and regular blood tests to track how the medication works in their bodies. It's important for potential participants to know that the study is still recruiting, and they should meet specific health criteria, especially regarding kidney function, to be eligible.

Gender

ALL

Eligibility criteria

• • Inclusion criteria applicable to all participants
• Participants will only be included in the trial if they meet the following criteria:
• • Male or female participants with age 18 to 80 years, inclusive at the screening visit.
• • Body mass index (BMI) of 20.0-40.0 kg/m\^2 (inclusive).
• • Signed and dated written informed consent in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use -good clinical practice (ICH-GCP) and local legislation prior to admission to the trial.
• • Male participants are not required to use contraception. Further criteria apply.
• • Inclusion criteria applying only to participants with impaired renal function
• • Renal impairment based on assessment of estimated glomerular filtration rate (eGFR) at screening (severe renal impairment: 10.0-29.9 mL/min/1.73 m\^2, moderate renal impairment: 30.0 - 59.9 mL/min/1.73 m\^2 (with at least 4 participants with a GFR between 30.0 and 45.0 mL/min/1.73m\^2), mild renal impairment: 60.0 - 89.9 mL/min/1.73 m\^2)
• • Chronic renal impairment \> 12 months (documented renal impairment indicated by reduced eGFR for more than 12 months until screening)
• • Absence of clinically significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening, with the exception of findings that in the opinion of the investigator are consistent with the participant's renal impairment.
• • Medication and/or treatment regimens must have been stable (i.e., no dose adjustments) for at least 4 weeks prior to the screening period and should be kept stable until study completion. Fluctuating treatment regimens may be considered for inclusion on a case-by-case basis if the underlying disease is under control in the opinion of the investigator and must be agreed to by both the investigator and the sponsor's medical monitor. Further criteria apply.
• • Exclusion criteria applying to all participants
• • Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• • Diseases of the central nervous system (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders (including but not limited to major depressive disorder)
• • History of relevant orthostatic hypotension, fainting spells, or blackouts
• • Relevant chronic or acute infections Further criteria apply.
• • Exclusion criteria applying only to participants with renal impairment
• • A marked prolongation of ECG interval from the start of the QRS complex (measured from the beginning of the Q wave to the end of the S wave) to the end of the T wave (QT)/QT interval corrected for heart rate, e.g. using the method of Fridericia (QTcF) or Bazett (QTcB)(QTc) interval (such as QTc intervals that are repeatedly greater than 480 milliseconds (ms) in males or repeatedly greater than 500 ms in females) or any other relevant ECG finding at screening
• • Acute renal failure or active nephritis
• • Nephrotic syndrome
• • Impaired hepatic function, including relevant increases in liver enzymes indicating liver disease Further criteria apply.