Testing how a medicine is absorbed in people with and without kidney problems

Pharmacokinetics, Safety, and Tolerability of BI 456906 Following Subcutaneous Injection in Male and Female Participants With Mild, Moderate and Severe Renal Impairment in Comparison to Participants With Normal Renal Function (Mono-centric, Open-label Study With Parallel Matched-pair Design)

This study is testing how well a new medication for obesity and liver conditions is absorbed in the body of adults with different levels of kidney function.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 2 sites (Kiel and 1 other locations)
• Trial ID: NCT06352411 on ClinicalTrials.gov

What this trial studies

This study involves adults aged 18 to 80 with a BMI of 20 to 40 kg/m², examining how the medication BI 456906 is absorbed in the bloodstream of individuals with varying degrees of kidney function. Participants are divided into four groups: one without kidney issues and three with mild, moderate, and severe renal impairment. Each participant without kidney problems is matched with those from the other groups based on age, gender, race, and body composition. The goal is to determine if kidney function affects the absorption of BI 456906, which is being developed for obesity and liver conditions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with a BMI between 20 and 40 kg/m², both with and without kidney problems.

Not a fit: Patients with significant comorbidities that severely affect kidney function or those outside the specified age and BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with obesity and liver problems, particularly those with concurrent kidney issues.

How similar studies have performed: While this approach is focused on a specific medication, similar studies assessing drug absorption in patients with renal impairment have shown promising results.

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.

Where this trial is running

Kiel and 1 other locations

• CRS Clinical Research Services Kiel GmbH — Kiel, Germany (Recruiting)
• CRS Clinical Research Services Mannheim GmbH — Mannheim, Germany (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Healthy; Renal Impairment